An Expanded Examination of Outcomes from Revisional Bariatric Surgery: A Needs Assessment

Bariatric surgery has been established as the first-line treatment for morbid obesity. Revisional bariatric surgery follows a failed or complicated primary bariatric procedure; however, the outcomes of revisional bariatric surgery remain controversial. The current recommendation for revisional surgery is to follow guidelines for primary surgery despite the significant differences. There is also a lack of evidence demonstrating the benefit of revisions, such as weight loss achievement and comorbidity improvement. This gap makes it difficult to assess the risk versus benefits of revisional bariatric surgery. As obesity rates increase exponentially, bariatric surgery is becoming more common, the cohort of patients is younger, and the need for revisional surgery is rising. A previous analysis was done, at St. Mark's Weight Treatment Center (SMWTC), to assess the benefits and complications of revisional surgery in their practice. Further analysis is required to understand whether these results are clinically significant and comparable to nationwide outcomes. This quality improvement project assessed outcomes from revisional bariatric surgery in 160 patients who had a revision done at St. Mark's Hospital between 2017 and 2021. A retrospective chart review was conducted using a checklist derived from the literature and was edited based on recommendations from the previous analysis. Data were extracted regarding complications, the timing of complications, and benefits from revisional surgery. The results were analyzed, and recommendations were developed from the literature with strategies to improve future surgery outcomes. Data extraction began with the patient's preoperative visit and continued until their follow-up one year after surgery. Supplemental data were gathered by an employee who conducted follow-up phone calls to patients who are now two to five years post-revision to assess current BMI and comorbidity improvement. The data were organized into tables and figures to demonstrate the findings. An executive report, including recommendations, was presented to the team at SMWTC, and feedback was obtained about usability and satisfaction with the results. The chart review revealed a total complication rate of 54%, with 20% of patients experiencing a minor complication only and 34% experiencing at least one major complication. The median decrease in BMI was 13.14 kg/m², and 21% of patients had documented comorbidity improvement. Two to five years post revision, 50% of comorbidities were described as much better or somewhat better by patients. One hundred percent of the team at SMWTC reported being very likely to implement recommendations into practice and being very satisfied with the findings and report. The findings from this study revealed a moderate complication rate, a mortality rate comparable to the literature, and a clinically significant decrease in BMI and rate of comorbidity improvement at one year of follow-up as well as two to five years post revisional surgery. The surgical team reported that this project was worthwhile, sustainable, and impactful in their practice. This information can help inform surgical decision-making, and the results of this study can guide patient counseling for those pursuing revisional bariatric surgery.

1 An Expanded Examination of Outcomes from Revisional Bariatric Surgery: A Needs Assessment Lauren M. Reynolds, Nicholas Paulk, Nancy A. Allen, and Sara Simonsen College of Nursing: The University of Utah NURS 7703: DNP Scholarly Project III May 7, 2023 2 Abstract Background: Bariatric surgery has been established as the first-line treatment for morbid obesity. Revisional bariatric surgery follows a failed or complicated primary bariatric procedure; however, the outcomes of revisional bariatric surgery remain controversial. The current recommendation for revisional surgery is to follow guidelines for primary surgery despite the significant differences. There is also a lack of evidence demonstrating the benefit of revisions, such as weight loss achievement and comorbidity improvement. This gap makes it difficult to assess the risk versus benefits of revisional bariatric surgery. Local Problem: As obesity rates increase exponentially, bariatric surgery is becoming more common, the cohort of patients is younger, and the need for revisional surgery is rising. A previous analysis was done, at St. Mark’s Weight Treatment Center (SMWTC), to assess the benefits and complications of revisional surgery in their practice. Further analysis is required to understand whether these results are clinically significant and comparable to nationwide outcomes. Methods: This quality improvement project assessed outcomes from revisional bariatric surgery in 160 patients who had a revision done at St. Mark’s Hospital between 2017 and 2021. A retrospective chart review was conducted using a checklist derived from the literature and was edited based on recommendations from the previous analysis. Data were extracted regarding complications, the timing of complications, and benefits from revisional surgery. The results were analyzed, and recommendations were developed from the literature with strategies to improve future surgery outcomes. Interventions: Data extraction began with the patient’s preoperative visit and continued until their follow-up one year after surgery. Supplemental data were gathered by an employee who conducted follow-up phone calls to patients who are now two to five years post-revision to assess current BMI and comorbidity improvement. The data were organized into tables and figures to demonstrate the findings. An executive report, including recommendations, was presented to the team at SMWTC, and feedback was obtained about usability and satisfaction with the results. 3 Results: The chart review revealed a total complication rate of 54%, with 20% of patients experiencing a minor complication only and 34% experiencing at least one major complication. The median decrease in BMI was 13.14 kg/m², and 21% of patients had documented comorbidity improvement. Two to five years post revision, 50% of comorbidities were described as much better or somewhat better by patients. One hundred percent of the team at SMWTC reported being very likely to implement recommendations into practice and being very satisfied with the findings and report. Conclusion: The findings from this study revealed a moderate complication rate, a mortality rate comparable to the literature, and a clinically significant decrease in BMI and rate of comorbidity improvement at one year of follow-up as well as two to five years post revisional surgery. The surgical team reported that this project was worthwhile, sustainable, and impactful in their practice. This information can help inform surgical decision-making, and the results of this study can guide patient counseling for those pursuing revisional bariatric surgery. Keywords: revisional, reoperative, secondary, bariatric surgery, outcomes, complications 4 An Expanded Examination of Outcomes from Revisional Bariatric Surgery: A Needs Assessment Problem Description According to the Center for Disease Control and Prevention (2021), the U.S. obesity rate is 41.9%, and 9.2% for severe obesity. Obesity-related conditions are among the most preventable, premature causes of death, including but not limited to heart disease, stroke, type 2 diabetes, and certain types of cancer (Center for Disease Control and Prevention, 2021). Bariatric surgery has long been established as the first-line treatment for morbid obesity as it is proven to be safe and effective while achieving sustainable weight loss; however, the outcomes of revisional bariatric surgery remain controversial (Mahawar et al., 2015; Qiu et al., 2018; Super et al., 2021). Revisional bariatric surgery follows a failed or complicated primary bariatric procedure (Super et al., 2021). Reports show that revisional surgery is primarily patient-driven and that weight regain is responsible for more than half of cases (Lee Bion et al., 2021; Mirkin et al., 2021). Other indications for revisional surgery include inadequate weight loss, insufficient improvement of obesity-related comorbidities, or complications secondary to the initial operation (Lee Bion et al., 2021; Mirkin et al., 2021). As obesity rates increase exponentially, bariatric surgery is becoming more common, the cohort of patients is younger, and the need for revisional surgery is increasing (Super et al., 2021; Qiu et al., 2018). Previously, the bariatric surgeons at St. Mark’s Weight Treatment Center (SMWTC) requested an analysis of the benefits and complications of reoperative bariatric surgery in their practice. Results showed a complication rate of 58% and a mortality rate of 2.5% (Crapo & Allen, 2022). There was a lack of evidence demonstrating the benefit of surgery, likely due to the identified gap in follow-up visits after surgery, as most patients were lost to follow-up within one year and had inadequate documentation of comorbidity improvements at follow-up visits (Crapo & Allen, 2022). Further analysis is required to understand whether these results are clinically significant and comparable to nationwide outcomes. Available Knowledge Revisional bariatric surgery represents an essential topic for treating obesity, a chronic relapsing disease. The rise in prevalence has led to an increase in bariatric surgeries, ultimately creating a need for 5 more revisional procedures from increasing rates of failure and complications following primary bariatric surgery (Lee Bion et al., 2021; Super et al., 2021). Revisional surgeries are becoming more common over time, currently making up 7%-15% of the total number of bariatric procedures (Mirkin et al., 2021). Some studies show even higher rates of revisional surgery, ranging from 10%-50% of patients undergoing secondary bariatric procedures (Cheema et al., 2021). Many recent studies report that revisional surgery is more complex, has higher rates of hemorrhage, and increased risk of intra-operative complications (Axer et al., 2019; Pinto-Bastos et al., 2017; Lee Bion et al., 2021). Additional findings indicate that revisional surgery has higher complication rates post-operatively, inadequate comorbidity resolution, and lower weight-loss results than primary surgery (Lee Bion et al., 2021; Mirkin et al., 2021). Across the available literature, including a survey of 460 surgeons from 62 countries, there is a demonstrated need for further research to identify best practices and standardized clinical practice guidelines regarding revisional bariatric surgery (Mahawar et al., 2018). The current recommendation for revisional surgery is to follow guidelines for primary surgery despite the significant differences in the operations and the higher complication rates in revisions (Dunham, 2020). While there is a need for an increased understanding of postoperative complications following revisional bariatric surgery, there is also a lack of evidence demonstrating the benefit of revisions, such as weight loss achievement and comorbidity improvement (Cheema et al., 2021). This gap makes it difficult to assess the risk versus benefits of revisional bariatric surgery. Revisional surgery has typically resulted in less weight loss than initial bariatric surgery, which now conflicts with new data. For example, one recent study showed satisfactory weight loss outcomes including a median decrease in BMI of 9.2 among all types of revisional surgery (Elshaer et al., 2019). However, both procedures are shown to be equally effective at improving obesity-related comorbidities and result in more weight loss and comorbidity improvement than medical management alone (Lee Bion et al., 2021; Mechanick et al., 2020). According to a systematic review by Pinto-Bastos et al. (2017), despite the high rates of medical complications associated with revisional surgeries compared to primary surgeries, the risk-benefit relationship favors the decision for a second surgery. Recent studies show satisfactory results, including successful weight loss 6 and significant improvements in cardiovascular risk and comorbidities like diabetes and hypertension (Cheema et al., 2021; Super et al., 2021). Weight loss success following revisional surgery is thought to be independent of the weight loss outcomes following primary surgery (Super et al., 2021). Additionally, an analysis by Andalib et al. (2021) demonstrated that at one year, revisional procedures offer further weight loss after a failed primary sleeve gastrectomy. Most agree that revisional bariatric surgery is associated with higher morbidity rates and less optimal outcomes than primary surgery. Nonetheless, data do support that revisional surgery can be performed safely, with excellent outcomes and improved quality of life for patients (Mirkin et al., 2021; Super et al., 2021). Rationale The Donabedian logic model was used to guide this quality improvement needs assessment to improve outcomes following revisional bariatric surgery. This conceptual model addresses quality improvement methods rather than findings and emphasizes shifting concern from evaluating quality to concentrating on understanding the medical care process itself (Donabedian, 2005). It includes measures of structures, processes, outcomes, and their effects on each other (Donabedian, 2005). Structures refer to physical and organizational characteristics in which care delivery occurs. Process refers to the workings of structures and processes in delivering care and helps determine whether care is being delivered appropriately. Outcomes refer to the impact of care delivery on patients, the results of improvements, and whether the intended goals were met (Donabedian, 2005). The structures involved in this project at SMWTC included the healthcare team of bariatric surgeons, one weight loss nurse practitioner, the clinic managing director, and the electronic medical record used for clinical data. The process consisted of current practices associated with revisional bariatric surgery at SMWTC. The measured outcomes were complications, comorbidity improvement, and weight loss following revisional surgery. Specific Aims The purpose of this project was to expand upon a previous needs assessment of revisional bariatric surgery outcomes by determining complication rates and when complications occurred, comorbidity improvement, and weight loss achievement. A secondary purpose of this project was to 7 provide practice improvement recommendations to the surgeons based on the chart review and findings in the literature. Methods Context This quality improvement project took place at St. Mark’s Weight Treatment Center. This clinic is a bariatric center in urban Millcreek, Utah, with surgeries performed at St. Mark’s Hospital. The team at this clinic consists of four bariatric surgeons, two advanced practice providers, three medical assistants, two registered nurses, and one clinic manager. There were 120 revisional bariatric surgeries performed between 1/1/2017 and 11/30/2020, and an analysis was conducted last year to assess the rate of complication and benefit for each type of revisional surgery. In that analysis, recommendations were developed with strategies intended to improve the outcomes for future surgeries. There were 40 revisional surgeries performed between 12/1/2020 and 12/6/2021. A further analysis was conducted to include new data from the 40 surgeries performed since the previous analysis, and expanded details were assessed for all 160 surgeries. Intervention(s) In phase one of this project, the checklist from the previous analysis was expanded upon (see Appendix A) to guide the chart review based on a review of more than 20 studies from the literature published within the past five years as well as recommendations from the surgeons at SMWTC. A list was obtained of the 120 patients who underwent revisional bariatric surgery between 1/1/2017 and 11/30/2020, deidentified by assigned numbers, as well as the data extracted from their electronic health records for the previous analysis. An additional list was obtained including the 40 patients who underwent revisional bariatric surgery between 12/1/2020 and 12/8/2021, and each were deidentified by assigning them a number, 122-161. A retrospective chart review was conducted in both the clinic and the hospital electronic health records, and data were extracted regarding complications and benefits from revisional surgery. Data extraction began with the patient’s preoperative visit and continued until their follow-up visit one year after surgery. Variables included gender, age, race/ethnicity, pre-operative BMI, 8 comorbidities, type of initial surgery, type of revisional surgery, duration of surgery, length of hospital stay, minor complications, major complications, timing of complications, and BMI one year after surgery. In this study, minor complications were defined as complications not requiring intervention and included diarrhea, nausea, vomiting, minor bleeding, hematoma, post-operative anemia, dysphagia, and reflux (Tran et al., 2016; Frantzides et al., 2019; Pinto-Bastos et al., 2017). Major complications were defined as complications requiring intervention or causing major morbidity or mortality. These included anastomotic or gastrointestinal (GI) leak, bowel paralysis or obstruction, venous thromboembolism, stricture, internal hernia, intraabdominal abscess, GI bleed, wound infection, malnutrition, perforation, hematemesis, ulceration, return to surgery, readmission with 30 days of discharge, ICU admission, sepsis, fistula, retained foreign body, GI ischemia, and death (Tran et al., 2016; Frantzides et al., 2019; Pinto-Bastos et al., 2017). Timing of complications, both minor and major, were reported at <1 month, 1–3-month, 3–6month, 6–9-month, and 9–12-months post-operatively. Electronic health records of patients from the previous analysis, who experienced minor and major complications, were re-reviewed to determine the timing of each complication. The data were then analyzed and separated by type of revisional surgery. The rate of complications, timing of complications, improvement of comorbidities, and change in BMI were then determined, and the data were organized into tables and graphs to demonstrate the findings. Additionally, supplemental data were gathered by an employee at SMWTC. This employee conducted follow-up phone calls to the original 120 patients, who underwent revisional bariatric surgery between 1/1/2017 and 11/30/2020, using a telephone survey that was developed based on a review of more than 20 studies from the literature published within the past five years (see Appendix B). This survey included questions about the date of their revisional surgery, the patient’s current weight, and selfreport of improvement or resolution of comorbidities including gastroesophageal reflux disease, hypertension, obstructive sleep apnea, dyslipidemia, type 2 diabetes, and pre-diabetes. These data were then analyzed and organized into tables and graphs to demonstrate the findings including change in BMI and improvement of comorbidities. 9 In phase two of this project, peer-reviewed articles from the past five years were studied to identify factors that impact outcomes from revisional bariatric surgery. Based on the chart review and literature review findings, recommendations were developed to address outcomes from reoperation at SMWTC. The complication and improvement rates and the strategies to improve outcomes were presented to the clinic team members in a PowerPoint presentation (see Appendix C). Feedback was obtained from the team members at this meeting and the team members were then presented with a final executive report. A survey was then sent to the surgeons and their team regarding the type and number of recommendations they intend to implement into their practice, the feasibility and usability of recommendations, and their overall satisfaction with the project. Study of the Intervention(s) For this project and the previous needs assessment, a checklist was derived from the literature to guide the chart review. Before beginning data extraction, this checklist was reviewed, revised, and approved by a bariatric surgeon at SMWTC. A detailed chart review was carried out to record patient demographics and clinical characteristics such as comorbidities, complications from surgery, when complications occurred, change in BMI, and improvement of comorbidities. Telephone surveys were conducted to follow up with patients 2-5 years post-revisional surgery regarding BMI changes, comorbidity improvement, and other complications. An executive report was generated from the findings of this study and a final survey was administered to the surgeons to determine the feasibility and usability of the project, including which recommendations they intend to implement into their practice. Measures The original checklist used for the chart review included gender, age, race/ethnicity, BMI the day of surgery, comorbidities, type of reoperation, duration of surgery, length of hospital stay, minor complications (complications not requiring intervention), major complications (complications requiring intervention or causing major morbidity or mortality), BMI at 1-year follow-up visit, months of follow-up (up to 12), and comorbidity improvement. The revised checklist (see Appendix A) included the same items as the original checklist with the addition of when minor and major complications occurred post- 10 surgery. Patient charts marked as having experienced minor and/or major complications that were reviewed using the original checklist were re-reviewed to determine the timing of their complications. Follow-up phone call interviews were made to the original 120 patients who are now 2-5 years post-revisional surgery. The survey used (see Appendix B) included questions about the date of their revisional surgery, the patient’s current weight, and self-report of improvement or resolution of comorbidities including gastroesophageal reflux disease, hypertension, obstructive sleep apnea, dyslipidemia, type 2 diabetes, and pre-diabetes. Response choices for rating comorbidity improvement consisted of much better, somewhat better, stayed the same, somewhat worse, and much worse. The patients were also asked if they have experienced any complications after their first-year post-surgery. The findings from the chart review, phone call surveys, and literature review were presented to the team at SMWTC in a PowerPoint presentation (see Appendix C). The comments and suggestions from the surgeons during this meeting were recorded in detailed notes, and modifications were made to the executive report based on their feedback. The team was presented with a document of the final executive report (see Appendix D). A final survey to determine feasibility, usability, and satisfaction was administered to the SMWTC surgeons (see Appendix E). The survey had 4 items that included both openended questions and Likert Scale questions. The open-ended questions helped determine perceived barriers to implementing the findings and recommendations and which specific recommendations the surgeons intended to implement into their practice. The Likert Scale questions addressed how likely the surgeons were to implement the findings into their practice and how satisfied they were with the project. Analysis Descriptive statistics, mean, median, standard deviation, range, number, and percentage were used to describe the quantitative data collected from the chart review. Descriptive statistics also explained the quantitative data collected from the phone call interviews. Notes were taken during the meeting with the SMWTC team, and their suggestions were implemented into the executive report. A content analysis was then performed on the open-ended survey questions answered by the surgeons following the final 11 executive report, by analyzing the survey responses line by line to develop common categories and subcategories. Ethical Considerations This project was deemed to be quality improvement in nature by the University of Utah Quality Improvement Self-Assessment process, and was not subject to institutional review board oversight. The St. Mark’s Hospital Research Council reviewed and approved this study. There were no conflicts of interest concerning this study. Results In phase one of this project, 160 cases of revisional bariatric surgery were reviewed. The demographic information of the population is summarized in Table 1. Eighty-eight percent (n=140) of the population was female, and 12% (n=20) was male. The patient sample was 97% (n=155) White, 1.3% (n=2) Black, and 1.9% (n=3) other or unknown race. Four percent (n=7) of the patient population was Hispanic or Latino, and 0.6% (n=1) was of unknown ethnicity. The average age on the day of surgery was 49 years (range 27-71). The clinical characteristics on the day of surgery are described in Table 2. The median BMI was 42.47 kg/m² (range 20.39-73.22 kg/m²). The obesity-related comorbidities with the highest prevalence were GERD (71.3%, n=114), obstructive sleep apnea (42.5%, n=68), and hypertension (40%, n=64). Most participants had more than one comorbidity. Conversion to duodenal switch was the most prevalent type of surgery, which accounted for 44.4% (n=71) of cases. Thirty-three percent (n=52) of cases were conversion to gastric bypass, 15% (n=24) were conversion to sleeve gastrectomy, and 8% (n=13) were revision gastrojejunostomy. An overview of the rates of complications and benefits is provided in Table 3. Of the 160 surgeries, 54.4% (n=87) were associated with at least one minor or major complication after one year of follow-up. Twenty percent (n=32) of the patients experienced minor complications only, while 34.4% (n=55) experienced at least one major complication. Duodenal switch was associated with the highest percentage of total complications (66.2%, n=47), including both major complications (42.3%, n=30) and minor complications (23.9%, n=17), and also had the greatest median decrease in BMI (14.7 kg/m², 12 range 5.52-27.26 kg/m²). Gastric bypass had the next highest percentage of total complications (48.1%, n=25) and yielded the highest percentage of comorbidity improvement (34.6%, n=18). Of the 160 patients, 40.6% (n=65) attended follow-up visits for one full year. Median decrease in BMI was only noted for those who followed up for one year and was 13.14 kg/m² (range -0.23-27.26 kg/m²). Comorbidity improvement was noted in 20.6% (n=33) of patient records. The incidence of each type of major complication is summarized in Table 4 and the timing of when these major complications occurred is outlined in Table 7 and Figures 2 and 3. The most common major complications were return to surgery (14.4%, n=23), readmission within 30 days (11.3%, n=18), stricture (11.3%, n=18), and bowel paralysis or obstruction (8.1%, n=13). Seventy-eight percent (n=18) of patients who returned to surgery had this occur within the first month. Among the 18 patients readmitted within 30 days, 10 (55.5%) were admitted to the ICU. Among those who experienced a stricture, 72% (n=13) were between 1-3 months post-surgery. Forty-six percent (n=6) of those with bowel paralysis or obstruction experienced this complication within one month of surgery, with 2 patients between 1-3 months, 1 between 3-6 months, 2 between 6-9 months, and 2 between 9-12 months. The mortality rate was 1.9% (n=3). Minor complications are outlined in Table 5 with their timing outlined in Table 6 and Figure 1. The most common minor complications were nausea/vomiting (25%, n=40), dysphagia (17.5%, n=28), and diarrhea (11.3%, n=18). The majority of nausea/vomiting cases were reported in the first three months (85%, n=34). Seventy-one percent (n=20) of dysphagia incidences occurred between 1-3 months with only 14% (n=4) occurring before one month. Among cases with reported diarrhea, 38.8% (n=7) occurred between 1-3 months and 22% (n=4) in the first month. For both major and minor complications, some patients experienced recurring complications, but the timing of the complication was documented only for the initial occurrence. Follow-up phone calls were made to 120 patients who are currently two to five years post revision surgery; the participation rate was 45.8% (n=55). Among the contacted patients, the median decrease in BMI since time of surgery was 11.71 kg/m² (range -7.91-35.56 kg/m²), found in Table 8. Current weight was patient-reported and BMI was calculated based off of the height in patient records. 13 Decrease in BMI was then calculated based off of pre-operative BMI. The patients were also asked about improvement or resolution of comorbidities including GERD, hypertension, obstructive sleep apnea, dyslipidemia, type 2 diabetes, and pre-diabetes; the results are summarized in Table 9. Among all comorbidities, 50% (n=79) were reported to be much better or somewhat better. Sixty percent (n=16) of cases with pre-diabetes reported this comorbidity as much better with obstructive sleep apnea having the next highest percentage of improvement with 52% (n=15) reporting their obstructive sleep apnea to be much better. The only comorbidity with reports of being much worse, other than one case of hypertension, was GERD (13.8%, n=5). Phase two of this project involved developing recommendations from the literature to address outcomes from reoperation at SMWTC, presenting the findings to the clinic team, modifying the executive report based on their suggestions, and obtaining feedback regarding feasibility, usability, and satisfaction after presentation of the final executive report. The outcome comparison to the literature can be reviewed in Appendix C. The recommendations presented to the surgeons outlined strategies to improve patient compliance and better outcomes after surgery. This included multidisciplinary reevaluation prior to surgery, and follow-up with a multidisciplinary team including social workers/psychiatry after revisional surgery (Lee Bion et al., 2021; Pinto-Bastos et al., 2017). Other recommendations included creating or fine-tuning a protocol for scheduling follow-up appointments and contacting patients when follow-up appointments are not attended, and creating a documentation template more specific to documenting comorbidity improvement so that the data are more complete. Following the initial presentation of the chart review, analysis, and literature findings, the surgeons recommended dividing the data further by what type of bariatric surgery was done primarily rather than only the type revisional surgery done. It was also suggested to separate patients who underwent surgery for any reason other than weight-regain or insufficient weight loss, such as patients who underwent surgery for improvement of reflux or other complications/comorbidities. They also recommended calculating weight loss as % EWL (excess weight loss), mean total body weight loss, or mean % excess BMI rather than decrease in BMI. While the allotted time for this study was insufficient to 14 implement these modifications, each suggestion would add to the overall relevance of this study and could be examined in the next phase of this project. Table 10 summarizes the final surgeon and advanced practice provider survey responses. Out of the four bariatric surgeons and two advanced practice providers, three survey responses were received. One hundred percent (N=3) of the team responded that they were “very likely” to use the information in their future practice, and 100% (N=3) responded that they were “very satisfied” with the project and executive report. An open-ended question asked what they intended to implement into their practice. Their responses included discussing this crucial information with patients as they assess the risk versus benefits of revisional bariatric surgery. They agreed that this information would enable them to make better decisions about whether revisional surgery is the right course of action in individual circumstances. Patients may use the data to decide on and prepare for surgery. When asked about barriers to implementing this information in their practice, responses included concerns about time constraints during patient consultations and the ability to disseminate all of the information. Discussion Summary A previous needs assessment performed at SMWTC showed a complication rate of 58%, a mortality rate of 2.5%, and a lack of evidence demonstrating the benefit of surgery. This needs assessment revealed a complication rate of 54%, a mortality rate of 1.9%, a median decrease in BMI of 13.14 kg/m² after one year, and 21% of patients with documented comorbidity improvement after one year. In patients two to five years post revisional bariatric surgery, the median decrease in BMI since surgery was 11.71 kg/m², and 50% of patient-reported comorbidities were described as much better or somewhat better. Recommendations were made to the team at SMWTC, which consisted of four bariatric surgeons, two advanced practice providers, three medical assistants, two registered nurses, and one clinic manager. Team members responded with reported intentions to implement the needs assessment recommendations into their practice. Interpretation 15 Revisional bariatric surgery can lead to significant weight loss and comorbidity improvement, resulting in improved quality of life for patients, despite the complication rate, which is reported to be higher than that of primary bariatric surgery. The median decrease in BMI of 13.14 kg/m² following revision in this study has the potential to improve health outcomes significantly. Even small amounts of weight loss are associated with decreased mortality rate and improved blood pressure, dyslipidemia, obstructive sleep apnea, and diabetes (Rueda Clausen et al., 2015). In addition, improved mental health, fertility, pregnancy outcomes, cancer outcomes, respiratory health, and gastrointestinal health, as lower rates of chronic pain, osteoarthritis, and cancer, are benefits associated with a decrease in BMI (Rueda Clausen et al., 2015). Recent studies specific to revisional bariatric surgery show satisfactory results in weight loss and improvements in cardiovascular risk and comorbidities like diabetes and hypertension (Cheema et al., 2021; Super et al., 2021), which was also proven to be true in this needs assessment at SMWTC. 30-day readmissions are commonly used as a key quality metric. A large study in Boston showed a 30-day readmission rate of 6.56% for secondary bariatric procedures (Vierra et al., 2022). The 30-day readmission rate at SMWTC is 11.3%. Another study showed 30-day readmission rates for Duodenal Switch at 5.9%, compared to 11.3% at SMWTC, 5.9% for Gastric Bypass, compared to 7.7% at SMWTC and 2.9% for Gastric Sleeve, compared to 12.5% at SMWTC (Bennett et al., 2022). Some readmissions are unavoidable even if bariatric perioperative care is optimized (Vierra et al., 2022). There is no significant difference in readmission rates between primary and secondary procedures, suggesting they can be performed in a high-volume center without negatively impacting important quality metrics (Vierra et al., 2022). When considering revisional surgery, multidisciplinary re-evaluation is essential (Lee Bion et al., 2021; Pinto-Bastos et al., 2017). Nutritional and lifestyle compliance is a critical factor in maintaining long-term weight loss. Research shows poor weight outcomes are associated with non-compliance with post-operative nutritional requirements. The recommendation is to be aware of the psychological variables that may compromise the necessary behavioral modifications and compliance, and a pre- 16 operative assessment is crucial. These points should be included in regular follow-up sessions to optimize weight outcomes. Follow-up with a multidisciplinary team is crucial (Pinto-Bastos et al., 2017). Following these recommendations, following up with social workers at SMWTC after revisional bariatric surgery may be beneficial. A low follow-up rate, in general, is concerning in this population due to the increased risk of clinical and nutritional problems. A further recommendation given to the team at SMWTC included creating or fine-tuning a protocol for scheduling follow-up appointments and contacting patients when follow-ups are not attended. Limitations The inconsistency in documenting comorbidity improvement and the high percentage of patients lost to follow-up created a limitation in thoroughly understanding the outcomes of this study. The median decrease in BMI was only calculated for those who followed up for one year, which was 41% of patients (n=65). A few patients were thought to have undergone revisional surgery for reasons other than weight loss. In that case, their decrease in BMI may not have contributed relatively to the median decrease in BMI. When determining the timing of complications, it was found that for both major and minor complications, some patients experienced recurring complications. However, the timing of complications was recorded only for the initial occurrence; this makes it difficult to assess the full spectrum of when complications occurred. When conducting follow-up phone calls to survey patients two to five years post revisional surgery, limitations involved patient-reported outcomes. The patient reported current weight, and BMI was calculated based on the height in their chart. The self-reported weight may have been inaccurate. Comorbidity improvement was also patient-reported, not based on clinical findings, blood work, or other testing. When comparing results from this study to outcomes in the literature, studies often report weight loss by % EWL (excess weight loss), mean total body weight loss, or mean % excess BMI rather than decrease in BMI, making it challenging to compare weight loss numbers directly. Many studies have small patient numbers and are very specific to one type of surgery or method, making it difficult to make meaningful comparisons. Many studies focus on indications for different types of 17 revisional surgery rather than outcomes. Another limitation of the data in this study at SMWTC is that it is a single practice in one geographic location with a relatively homogenous population. Conclusions Despite the ongoing rise in obesity prevalence, leading to the need for more revisional bariatric surgeries from increasing rates of failure and complications following primary bariatric surgery, there are gaps in the data regarding the risks and benefits of revisional surgery. This project aimed to add to the science in this area by providing a comprehensive overview of the surgical outcomes at one urban weight treatment center, which consisted of 160 revisional bariatric procedures carried out within the past five years. The findings from this study revealed a moderate complication rate, a mortality rate comparable to the literature, and a clinically significant decrease in BMI and rate of comorbidity improvement at one year of follow-up as well as two to five years post revisional surgery. The surgical team reported that this project was worthwhile, sustainable, and impactful in their practice. This information can help inform surgical decision-making, and the results of this study can guide patient counseling for those pursuing revisional bariatric surgery. The process used for this project could also be applied in other bariatric surgical centers to gather a broader understanding of outcomes from revisional surgery. The next steps for this project include separating patients by indication for revisional surgery, calculating BMI changes using other formulas to more easily compare weight loss outcomes to the literature, refining follow-up protocols to increase follow-up rates, and improving clinic documentation of comorbidity improvement. 18 Acknowledgements Dr. Nicholas Paulk, Dr. Elizabeth Hanna, Alicia Allen, Dr. Kelsey Crapo, Dr. Nancy Allen, and Dr. Sara Simonsen significantly contributed to the completion of this project through their participation, guidance, feedback, and support throughout the process. 19 References Andalib, A., Alamri, H., Almuhanna, Y., Bouchard, P., Demyttenaere, S., & Court, O. (2021). Short-term outcomes of revisional surgery after sleeve gastrectomy: A comparative analysis of re-sleeve, Roux en-Y gastric bypass, duodenal switch (Roux en-Y and single-anastomosis). Surgical Endoscopy, 35(8), 4644–4652. https://doi.org/10.1007/s00464-020-07891-z Axer, S., Szabo, E., Agerskov, S., & Näslund, I. (2019). Predictive factors of complications in revisional gastric bypass surgery: Results from the Scandinavian Obesity Surgery Registry. Surgery for Obesity and Related Diseases, 10(12), 2094-2100. http://doi.org/10.1016/j.soard.2019.09.071 Bennett, W. C., Garbarine, I. C., Mostellar, M., Lipman, J., Sanchez-Casalongue, M., Farrell, T., & Zhou, R. (2023). Comparison of early post-operative complications in primary and revisional laparoscopic sleeve gastrectomy, gastric bypass, and duodenal switch MBSAQIP-reported cases from 2015 to 2019. Surgical Endoscopy. https://doi.org/10.1007/s00464-022-09796-5 Center for Disease Control and Prevention (2021). Adult obesity facts. https://www.cdc.gov/obesity/data/adult.html Cheema, F., Choi, M., Moran-Atkin, E., Camacho, D., & Choi, J. (2021). Outcomes in revisional bariatric surgery: A high-volume single institution experience. Surgical Endoscopy, 35(7), 3932–3939. https://doi.org/10.1007/s00464-020-07855-3 Crapo, K. S., & Allen, N. A. (2022). Outcomes from reoperative bariatric surgery: A needs assessment. College of Nursing, University of Utah. Donabedian, A. (2005). Evaluating the quality of medical care. The Millbank Quarterly, 83(4), 691-729. https://doi.org/10.1111/j.1468-0009.2005.00397.x Dunham, M. (2020). Revisional surgery evaluation and contraindications. Bariatric Times, 17(3), 16-17. Elshaer, M., Hamaoui, K., Rezai, P., Ahmed, K., Mothojakan, N., & Al-Taan, O. (2019). Secondary bariatric procedures in a high-volume centre: Prevalence, indications and outcomes. Obesity Surgery, 29(7), 2255–2262. https://doi.org/10.1007/s11695-019-03838-z Frantzides, C. T., Alexander, B., & Frantzides, A. T. (2019). Laparoscopic revision of failed bariatric 20 procedures. Journal of the Society of Laparoendoscopic Surgeons, 23(1). https://doi.org/10.4293/Jsls.2018.00074 Lee Bion, A., Le Roux, Y., Alves, A., & Menahem, B. (2021). Bariatric revisional surgery: What are the challenges for the patient and the practitioner? Journal of Visceral Surgery, 158(1), 38–50. https://doi.org/10.1016/j.jviscsurg.2020.08.014 Mahawar, K. K., Graham, Y., Carr, W. R. J., Jennings, N., Schroeder, N., Balupuri, S., & Small, P. K. (2015). Revisional Roux-en-Y Gastric Bypass and Sleeve Gastrectomy: A Systematic Review of Comparative Outcomes with Respective Primary Procedures. Obesity Surgery, 25(7), 1271–1280. https://doi.org/10.1007/s11695-015-1670-2 Mahawar, K. K., Nimeri, A., Adamo, M., Borg, C.-M., Singhal, R., Khan, O., & Small, P. K. (2018). Practices concerning revisional bariatric surgery: A survey of 460 surgeons. Obesity Surgery, 28(9), 2650–2660. https://doi.org/10.1007/s11695-018-3226-8 Mechanick, J. I., Apovian, C., Brethauer, S., Garvey, W. T., Joffe, A. M., Kim, J., Kushner, R. F., Lindquist, R., Pessah-Pollack, R., Seger, J., Urman, R. D., Adams, S., Cleek, J. B., Correa, R., Figaro, M. K., Flanders, K., Grams, J., Hurley, D. L., Kothari, S.,…Still, C. D. (2020). Clinical practice guidelines for the perioperative nutrition, metabolic, and nonsurgical support of patients undergoing bariatric procedures- 2019 update. Surgery for Obesity and Related Diseases, 16, (175-247). https://doi.org/10.1016/j.soard.2019.10.025 Mirkin, K., Alli, V. V., & Rogers, A. (2021). Revisional bariatric surgery. The Surgical Clinics of North America, 101(2), 213-222. https://doi.org/10.1016/j.suc.2020.12.008 Pinto-Bastos, A., Conceição, E. M., & Machado, P. P. P. (2017). Reoperative bariatric surgery: A systematic review of the reasons for surgery, medical and weight loss outcomes, relevant behavioral factors. Obesity Surgery, 27(10), 2707–2715. https://doi.org/10.1007/s11695-0172855-7 Qiu, J., Lundberg, P. W., Javier Birriel, T., Claros, L., Stoltzfus, J., & El Chaar, M. (2018). Revisional bariatric surgery for weight regain and refractory complications in a single MBSAQIP accredited 21 center: What are we dealing with? Obesity Surgery, 28(9), 2789–2795. https://doi.org/10.1007/s11695-018-3245-5 Rueda-Clausen, C. F., Ogunleye, A. A., & Sharma, A. M. (2015). Health benefits of long-term weightloss maintenance. Annual Review of Nutrition, 35(1), 475-516. https://doiorg.ezproxy.lib.utah.edu/10.1146/annurev-nutr-071714-034434 Super, J., Charalampakis, V., Tahrani, A. A., Kumar, S., Bankenahally, R., Raghuraman, G., Jambulingam, P. S., Kelly, J., Ammori, B. J., & Singhal, R. (2021). Safety and feasibility of revisional bariatric surgery following laparoscopic adjustable gastric band – Outcomes from a large UK private practice. Obesity Research & Clinical Practice, 15(4), 381–386. https://doi.org/10.1016/j.orcp.2021.06.001 Tran, D. D., Nwokeabia, I. D., Purnell, S., Zafar, S. N., Ortega, G., Hughes, K., & Fullum, T. M. (2016). Revision of roux-en-y gastric bypass for weight regain: A systematic review of techniques and outcomes. Obesity Surgery, 26(7), 1627-1634. https://doi.org.ezproxy.lib.utah.edu/10.1007/s11695-016-2201-5 Vierra, B. M., Edgerton, C. A., & Shikora, S. A. (2022). The impact of procedure type on 30-day readmissions following metabolic and bariatric surgery: Postoperative complications of bariatric surgery. Surgical Endoscopy. https://doi.org/10.1007/s00464-022-09720-x 22 Tables and Figures 23 24 25 26 27 28 29 30 31 Table 10 Stakeholder Survey Responses Survey Question How likely are you to use the information from Open and Closed-Ended Responses 100% (N=3) responded “very likely” this project in your future practice? What do you intend to implement into your Utilize this crucial information to discuss risk vs practice? benefit of revisional surgery with patients. Help patients decide on and prepare for surgery. Will enable the team to make better decisions in each individual circumstance. What are the barriers to implementing the Ability to disseminate results. Time constraints information obtained from this project? during patient consultations. Rate your overall satisfaction with this project and 100% (N=3) responded “very satisfied” executive report: 32 Figure 1 Timing of Minor Complications 33 Figure 2 Timing of Major Complications 34 Figure 3 Timing of Major Complications (Continued) 35 Appendix A Checklist for Chart Review  Gender  Age  Race/ethnicity  BMI the day of surgery  Comorbidities (GERD, hypertension, OSA, dyslipidemia, type 2 diabetes, pre-diabetes)  Type of reoperation  Duration of surgery  Length of hospital stay  Minor complications (complications not requiring intervention) o Diarrhea, nausea/vomiting, minor bleeding, hematoma, post-operative anemia, dysphagia, reflux)  Major complications (complications requiring intervention or causing major morbidity or mortality) o Anastomotic/gastrointestinal leak, bowel paralysis/obstruction, venous thromboembolism, stricture, ventral hernia, internal hernia, intraabdominal abscess, gastrointestinal bleed, wound infection, malnutrition, perforation, hematemesis, ulceration, return to surgery, intensive care unit admission, readmission within 30 days of discharge, sepsis, fistula, retained foreign body, gastric or intestinal ischemia, death)  When each complication occurred after surgery (1-month, 3-month, 6-month, 9-month intervals)  BMI at 1-year follow-up visit  Months of follow-up (up to 12)  Comorbidity improvement 36 Appendix B Reoperative Bariatric Surgery Follow-Up Phone Calls Date of phone call: Patient name (Last, First): 1. What was the date of your reoperative surgery? __________________ 2. What is your current weight? ________________ 3. Have you had improvement or resolution of comorbidities including: A. Gastroesophageal reflux disease (yes/no/NA) If yes or no then: a. Much better b. Somewhat better c. Stayed the same d. Somewhat worse e. Much worse B. Hypertension (high blood pressure) (yes/no/NA) If yes or no then: a. Much better b. Somewhat better c. Stayed the same d. Somewhat worse e. Much worse C. Obstructive sleep apnea (yes/no/NA) If yes or no then: a. Much better b. Somewhat better c. Stayed the same d. Somewhat worse e. Much worse D. Dyslipidemia (elevated cholesterol or triglycerides) (yes/no/NA) If yes or no then: 37 a. Much better b. Somewhat better c. Stayed the same d. Somewhat worse e. Much worse E. Type 2 diabetes (yes/no/NA) If yes or no then: a. Much better b. Somewhat better c. Stayed the same d. Somewhat worse e. Much worse F. Pre-diabetes (yes/no/NA) If yes or no then: a. Much better b. Somewhat better c. Stayed the same d. Somewhat worse e. Much worse 4. Have you experienced any complications after your first-year post-surgery? Please explain: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ 38 Appendix C Executive Report Draft- PowerPoint Presentation 39 40 41 42 43 44 45 46 47 48 49 50 51 Appendix D Executive Report: Expanded Outcomes from Reoperative Bariatric Surgery Problem Statement: • Revisional bariatric surgery is a newer and more complex procedure with increased complications and mortality compared to primary surgery • The current recommendation for revision is to follow guidelines for primary surgery despite the significant differences (Dunham, 2020) • While there is a need for increased understanding of postoperative complications, there is also a lack of evidence demonstrating the benefit of revisions, such as weight loss achievement and comorbidity improvement (Cheema et al., 2021) • This gap makes it difficult to assess the risk versus benefit of revisional bariatric surgery Objectives: 1. Assess types and timing of complications, comorbidity improvement, and weight loss outcomes from revisional bariatric surgery at St Mark’s Weight Treatment Center (SMWTC) 2. Compare findings at SMWTC with national outcomes and identify potential strategies to improve outcomes 3. Develop recommendations to improve outcomes and present findings to the surgeons 4. Evaluate feedback from the surgeons regarding the recommendations they intend to implement into their practice Methods: A list was obtained of the 120 patients who underwent revisional surgery between 1/1/201711/30/2020 and their data from the original analysis. An additional list of 40 patients was obtained including those who underwent revisional surgery between 12/1/2020 and 12/8/202. A checklist was 52 developed from the literature, and was edited based on recommendations from the previous analysis. A retrospective chart review was conducted on the 40 additional patients and the original 120 patient charts were re-reviewed to determine the timing of their complications over one year. Supplemental data was gathered by an employee who conducted follow-up phone calls to the original 120 patients. Telephone surveys included questions about the date of their revisional surgery, the patient’s current weight, improvement of comorbidities including GERD, HTN, OSA, dyslipidemia, T2DM, and pre-diabetes. A preliminary data analysis was performed, using Microsoft Excel, for the chart review and the follow-up phone calls. Data Gathered from Chart Review: The following data was obtained from each patient record:  Gender, age, race/ethnicity, BMI day of surgery, comorbidities, type of reoperation, duration of surgery, length of hospital stay, minor complications, major complications, when each complication occurred, BMI at 1-year follow-up, months of follow-up (up to 12), comorbidity improvement o Comorbidities included: gastroesophageal reflux disease (GERD), hypertension (HTN), obstructive sleep apnea (OSA), dyslipidemia, type 2 diabetes (DM2), and pre-diabetes (Tran et al., 2016; Frantzides et al., 2019; Pinto-Bastos et al., 2017)  Results summarized in Tables and Figures Major and Minor Complications: Minor complications were defined as complications not requiring intervention, and included:  Diarrhea, nausea/vomiting, minor bleeding, hematoma, post-operative anemia, dysphagia, reflux Major complications were defined as complications requiring intervention or causing major morbidity or mortality. These included:  Anastomotic/gastrointestinal (GI) leak, bowel paralysis/obstruction, VTE, stricture, ventral 53 hernia, internal hernia, intraabdominal abscess, GI bleed, wound infection, malnutrition, perforation, hematemesis, ulceration, return to surgery, intensive care unit (ICU) admission, readmission within 30 days of discharge, sepsis, fistula, retained foreign body, gastric or intestinal ischemia, death (Tran et al., 2016; Frantzides et al., 2019; Pinto-Bastos et al., 2017) Outcome Comparison: A large retrospective database analysis showed a table of postoperative outcomes by type of revisional surgery (Vanetta et al., 2022). Limitations of this study include the lack of definitions for each outcome and the criteria used. This study also only looked at the first 30 days, not one year, so it was compared to only the complications experienced within the first 30 days at SMWTC. Of 13,257 revisional operations, 0.5% experienced anastomotic or GI leak compared to 5.6% at SMWTC; 0.9 % experienced bowel obstructions compared to 3.8% at SMWTC; 0.8% were admitted to the ICU compared to 6.3% at SMWTC; 0.3% had sepsis compared to 3.8% at SMWTC; 2.5% underwent reoperations compared to 11.3% at SMWTC; and there was a 0.1% mortality rate compared to 1.3% at SMWTC (Vanetta et al., 2022). According to another study, the overall mortality rate is estimated to be about 2%, showing higher values when compared to those estimated for primary procedures, which is expected to range between 0.1% and 1.1% (Pinto-Bastos et al., 2017). The one-year mortality rate for revisional bariatric surgery at SMWTC is 1.9%. 30-day readmissions are commonly used as a key quality metric. A large study in Boston showed a 30-day readmission rate of 6.56% for secondary bariatric procedures (Vierra et al., 2022). The 30-day readmission rate at SMWTC is 11.3%. Another study showed 30-day readmission rates for Duodenal Switch at 5.9%, compared to 11.3% at SMWTC, 5.9% for Gastric Bypass, compared to 7.7% at SMWTC and 2.9% for Gastric Sleeve, compared to 12.5% at SMWTC (Bennett et al., 2022). Some readmissions are unavoidable even if bariatric perioperative care is optimized (Vierra et al., 2022). There is no significant difference in readmission rates between primary and secondary procedures, suggesting they 54 can be performed in a high-volume center without negatively impacting important quality metrics (Vierra et al., 2022). Similarly to primary surgery, a few studies have shown that most of the weight loss occurs within the first 12 months after revisional bariatric surgery (Pinto-Bastos et al., 2017). Studies often report weight loss by % EWL (excess weight loss), mean total body weight loss, or mean % excess BMI rather than decrease in BMI, making it difficult to directly compare weight loss numbers. Many studies have small patient numbers and are very specific to one type of surgery or method, making it difficult to make meaningful comparisons and many studies focus on indications for different types of revisional surgery rather than outcomes. The evidence does support the indication of revisional surgery to address the persistence of obesity and/or comorbidities, complications, and refractory symptoms (Vanetta et al., 2022). Literature Findings and Other Recommendations: When considering revisional surgery, multidisciplinary re-evaluation is essential (Lee Bion et al., 2021; Pinto-Bastos et al., 2017). Nutritional and lifestyle compliance is a critical factor in maintaining long-term weight loss, and research shows that poor weight outcomes are associated with non-compliance with post-operative nutritional requirements. The recommendation is to be aware of the psychological variables that may compromise the necessary behavioral modification and compliance and a pre-operative assessment is crucial. These points should be included in regular follow-up sessions to optimize weight outcomes; Follow-up with a multidisciplinary team is crucial (Pinto-Bastos et al., 2017). Following these recommendations, it may be beneficial to follow-up with social workers at SMWTC after revisional surgery. Other ideas going forward include creating or fine-tuning a protocol for scheduling follow-up appointments and contacting patients when follow-ups are not attended; the one-year follow up rate was 40.6%. Another recommendation is to create an electronic health record template more specific to documenting comorbidity improvement so that data is more complete; the total comorbidity improvement rate was 20.6% but only 33 charts had that documented. 55 Appendix E Survey Questions 1. How likely are you to use the information from this project in your future practice? o Very unlikely o Somewhat unlikely o Neutral o Somewhat likely o Very likely 2. What (if anything) do you intend to implement into your practice? 3. What are the barriers to implementing the information obtained from this project (if any)? 4. Rate your overall satisfaction with this project and executive report: o Very unsatisfied o Somewhat unsatisfied o Neutral o Somewhat satisfied o Very satisfied