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Transoral Oulet Reduction with Full Thickness Endoscopic Suturing for Weight Regain after Gastric Bypass: A Large Multicenter International Experience and Meta-Analysis
Table 1: Summary of Patient Characteristics
Su2040
Background: Intragastric balloon (IGB) treatment for obesity is a minimally-invasive outpatient procedure that is currently recommended for weight loss in some patients who fail lifestyle interventions. The aim of this study is to analyze the long-term results regarding efficacy, tolerability and patient satisfaction, in a cohort of patients who undergone IGB insertion. Methods: All the patients that had their IGB inserted or removed between the years 2009 and 2016 at the American University of Beirut Medical Center were contacted by phone and asked to answer a short questionnaire. Baseline characteristics, pre and post IGB weight, as well as their current weight were recorded. Different parameters of satisfaction were noted in addition to whether or not they resorted to alternative weight reduction measures. Results: A total of 99 patients were identified, 65 of which agreed to participate and were included in the final analysis. Of those patients, 21.5% were male and 78.5% were females; their mean age was 39 years and their mean baseline BMI was 32.9kg/m2. The mean weight loss achieved at the end of the treatment period (3 to 10 months) was 11.1kg (range : -7 to 37) corresponding to 12% decrease from baseline. Only 30.8% of our patients were satisfied with the overall experience and 44.6% were satisfied with the weight loss achieved (Table 1). Satisfied patients were similar to those in the unsatisfied group except that they reported significantly higher weight loss at IGB removal (Table 2).When assessing the long-term follow up after IGB removal (mean of 2.4 years with a maximum of 5 years), the vast majority of our patients (78.7%) regained weight and 35.6% resorted to further bariatric measures. Conclusion: IGB is an effective short-term approach for weight loss. It could be recommended for patients seeking rapid and safe methods of weight reduction. However, this approach does not offer long lasting results and most patients were not satisfied with the experience. The level of satisfaction appears to correlate with the initial degree of weight loss. Patient satisfaction with the overall procedure and other specific parameters.
Table 2. Multivariate analysis assessing effect of joint repair on weight-regain post-endoscopic revision adjusted for co-variates at 3 months, 6 months, 1 year, 2 years, and 3 years
Su2039 TRANSORAL OULET REDUCTION WITH FULL THICKNESS ENDOSCOPIC SUTURING FOR WEIGHT REGAIN AFTER GASTRIC BYPASS: A LARGE MULTICENTER INTERNATIONAL EXPERIENCE AND META-ANALYSIS Eric J. Vargas, Tarun Rustagi, Monika Rizk, Andres J. Acosta Cardenas, Fateh Bazerbachi, Erik B. Wilson, Todd Wilson, Manoel Galvao Neto, Natan Zundel, Maria L. CollazoClavell, H.S Abu-Lebdeh, Todd A. Kellogg, Travis J. McKenzie, Michael L. Kendrick, Mark Topazian, Christopher Gostout, Barham K. Abu Dayyeh Background and Aims: Weight recidivism occurs in about 25% of patients after Roux-enY gastric bypass (RYGB). A dilated gastrojejunal anastomosis (GJA) is a well-established independent predictor for weight regain. Endoscopic transoral oulet reduction (TORe) has been preferred over surgical revision due to its minimally invasive nature; however, long term efficacy data is limited. Our aims were to report safety and long term efficacy data from three high volume centers and conduct a systematic review and meta-analysis of the available literature to assess reproducibility and generalizability of the technique. Methods: Patients who underwent TORe using a full-thickness endoscopic-suturing device for the treatment of weight regain after RYGB (Overstitch, Apollo Endosurgery, Austin, Tx) among three centers in Minnesota, Texas and South America between January 2013- November 2016 were included in the study. Data was entered into a prospectively-maintained database at each center that was retrospectively reviewed for this analysis. For the systematic review and meta-analysis, a comprehensive search of Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, Scopus, and Web of Science was conducted. Two independent reviewers reviewed all citations and identified clinical studies published in English investigating TORe with a full thickness endoscopic suturing device for the management of weight regain after RYGB. A random-effects meta-analysis was performed. Results: 130 consecutive patients (Minnesota [n=50], Texas [n=42], South America [n=38]) underwent post-RYGB TORe revision for their GJA. These patients (age 47 ± 8.55 years, BMI of 36.8 ± 6.84 kg/m2) had experienced 24.6% ± 15.6 weight regain from nadir at 8.4 ± 4.78 years from their index surgery at the time of endoscopic revision. Average weight lost at 6, 12, and 18 months after TORe was 9.31kg ± 6.7(n=84), 7.75kg ± 8.4 (n=70), 8 ± 8.8kg (n=46) (p<0.01 for all three time points), respectively. Percent excess weight loss (%EWL) at 12 months was 20.2% ± 10. In a meta-analysis that included 330 patients (n=130 our series and n=200 published in the literature) (Table 1), the pooled weight loss at 12 months using a random effects model was 8.3kg [95% CI 5.9-10.7] with acceptable heterogeneity (Q value = 5.1, I2 60.9). No serious device or treatment-related adverse events were reported and all procedures done in the outpatient setting Conclusion: TORe with a full thickness endoscopic suturing device is a safe and effective technique with durable weight loss. Given the morbidity and cost of revision surgery, TORe should be considered the initial intervention of choice for post RYGB weight-regain patients.
Su2041 ENDOSCOPIC MANAGEMENT OF GASTRIC LEAKS AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY, BY INTERNAL DRAINAGE WITH DOUBLE PIGTAIL STENT: BARTOLI PROCEDURE Constance Deschepper, Lionel Rebibo, Jean Philippe Le Mouel, Adrien Wacrenier, Franck Brazier, Mathurin Fumery, Richard Delcenserie, Cyril Cosse, Abdennaceur Dhahri, Henri Thiebault, Jean Marc Regimbeau, Jean-Louis Dupas, Eric Nguyen-Khan, Sami Hakim Background : Gastric leak (GL) after sleeve gastrectomy (SG) is the main early postoperative complication, reported in about 2.5% of patients. There is no consensus on the management of these fistula. We aimed to evaluate the efficacy and safety of internal endoscopic drainage of GL after SG by double pigtail stent (DPS). Methods : Between December 2009 and March 2016 (Total Period, TP), all patients with GL after SG initially treated by DPS were consecutively included and retrospectively analyzed. Before the establishement of a standardized technique after January 2014 (Period 2, P2), different modalities of endoscopic management by DPS were evaluated between December 2009 and December 2013 (Period 1, P1). The primary outcome was to evaluate the efficacy of the internal drainage by DPS during the TP, and to compare P1 and P2 periods. Efficacy was defined by refeeding without any abdominal collection, sepsis, endoscopic prothesis and external drainage module. Results : Eighty-two patients were included, 34 for P1 and 48 for P2. The median follow up after GL diagnosis was 64 days (extremes, 25-412). Endoscopic drainage by DPS was effective in 79.3% of patients (n=65) for TP, 67.7 % (n=23) for P1 and 87.5% (n=42) for P2 (p= 0.028). Radical surgery rate after endoscopic treatment failure was 3.7 %(n=3) during the total period. Median duration to fistula healing was 58 days ( 18-204) for the TP, 70 days (24-363) for P1 and 48.5 days (18-125) for P2 (p=0.003). Endoscopic complications were observed in 20.7% of patients (n=17) for the TP, with a migration rate of 17.1% (n=14) and a perforation rate of 3.6% (n=3). After migration, new endoscopic procedure was needed in 57.1 % (n=8) of cases. Median number of procedure per patients was 2 (1-5) for TP, 3 (1-5) for P1 and 2 (1-5) for P2 (p=0.0012). Median hospitalization duration for the TP, P1 and P2 were respectively, 16 days (3-87), 20 days (7-87) and 14.5 days (3-42) (p=0.019). Rate of hospitalization in intensive care unit for the TP, P1 and P2 were respectively, 24.6 % (n=16), 39.1% (n=9) and 16.6 %( n=7) (p=0.04). For the TP, median duration of ablation of the external drainage module after DPS drainage was 4 days (extremes, 1-17) and clinical tolerance of DPS was 97.6%. No deaths were observed during follow-up. Conclusions : This is the largest cohort of patients with GL after SG. Management of these patients by standardized endoscopic drainage with DPS is safe and effective, with a good tolerance. This technique is associated with easy management of external drainage modules, short hospitalization duration and a low rate of radical surgery.
S-637
AGA Abstracts
AGA Abstracts
INTRAGASTRIC BALLOON TREATMENT FOR OBESITY: MEDIUM, LONGTERM RESULTS, AND PATIENT SATISFACTION Yasser H. Shaib, Aline K. El Haddad, Assaad Soweid, Ala I. Sharara, Fady Daniel, Mohammad Rammal, Mahmoud Rahal
Su2040
Background: Intragastric balloon (IGB) treatment for obesity is a minimally-invasive outpatient procedure that is currently recommended for weight loss in some patients who fail lifestyle interventions. The aim of this study is to analyze the long-term results regarding efficacy, tolerability and patient satisfaction, in a cohort of patients who undergone IGB insertion. Methods: All the patients that had their IGB inserted or removed between the years 2009 and 2016 at the American University of Beirut Medical Center were contacted by phone and asked to answer a short questionnaire. Baseline characteristics, pre and post IGB weight, as well as their current weight were recorded. Different parameters of satisfaction were noted in addition to whether or not they resorted to alternative weight reduction measures. Results: A total of 99 patients were identified, 65 of which agreed to participate and were included in the final analysis. Of those patients, 21.5% were male and 78.5% were females; their mean age was 39 years and their mean baseline BMI was 32.9kg/m2. The mean weight loss achieved at the end of the treatment period (3 to 10 months) was 11.1kg (range : -7 to 37) corresponding to 12% decrease from baseline. Only 30.8% of our patients were satisfied with the overall experience and 44.6% were satisfied with the weight loss achieved (Table 1). Satisfied patients were similar to those in the unsatisfied group except that they reported significantly higher weight loss at IGB removal (Table 2).When assessing the long-term follow up after IGB removal (mean of 2.4 years with a maximum of 5 years), the vast majority of our patients (78.7%) regained weight and 35.6% resorted to further bariatric measures. Conclusion: IGB is an effective short-term approach for weight loss. It could be recommended for patients seeking rapid and safe methods of weight reduction. However, this approach does not offer long lasting results and most patients were not satisfied with the experience. The level of satisfaction appears to correlate with the initial degree of weight loss. Patient satisfaction with the overall procedure and other specific parameters.
Table 2. Multivariate analysis assessing effect of joint repair on weight-regain post-endoscopic revision adjusted for co-variates at 3 months, 6 months, 1 year, 2 years, and 3 years
Su2039 TRANSORAL OULET REDUCTION WITH FULL THICKNESS ENDOSCOPIC SUTURING FOR WEIGHT REGAIN AFTER GASTRIC BYPASS: A LARGE MULTICENTER INTERNATIONAL EXPERIENCE AND META-ANALYSIS Eric J. Vargas, Tarun Rustagi, Monika Rizk, Andres J. Acosta Cardenas, Fateh Bazerbachi, Erik B. Wilson, Todd Wilson, Manoel Galvao Neto, Natan Zundel, Maria L. CollazoClavell, H.S Abu-Lebdeh, Todd A. Kellogg, Travis J. McKenzie, Michael L. Kendrick, Mark Topazian, Christopher Gostout, Barham K. Abu Dayyeh Background and Aims: Weight recidivism occurs in about 25% of patients after Roux-enY gastric bypass (RYGB). A dilated gastrojejunal anastomosis (GJA) is a well-established independent predictor for weight regain. Endoscopic transoral oulet reduction (TORe) has been preferred over surgical revision due to its minimally invasive nature; however, long term efficacy data is limited. Our aims were to report safety and long term efficacy data from three high volume centers and conduct a systematic review and meta-analysis of the available literature to assess reproducibility and generalizability of the technique. Methods: Patients who underwent TORe using a full-thickness endoscopic-suturing device for the treatment of weight regain after RYGB (Overstitch, Apollo Endosurgery, Austin, Tx) among three centers in Minnesota, Texas and South America between January 2013- November 2016 were included in the study. Data was entered into a prospectively-maintained database at each center that was retrospectively reviewed for this analysis. For the systematic review and meta-analysis, a comprehensive search of Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, Scopus, and Web of Science was conducted. Two independent reviewers reviewed all citations and identified clinical studies published in English investigating TORe with a full thickness endoscopic suturing device for the management of weight regain after RYGB. A random-effects meta-analysis was performed. Results: 130 consecutive patients (Minnesota [n=50], Texas [n=42], South America [n=38]) underwent post-RYGB TORe revision for their GJA. These patients (age 47 ± 8.55 years, BMI of 36.8 ± 6.84 kg/m2) had experienced 24.6% ± 15.6 weight regain from nadir at 8.4 ± 4.78 years from their index surgery at the time of endoscopic revision. Average weight lost at 6, 12, and 18 months after TORe was 9.31kg ± 6.7(n=84), 7.75kg ± 8.4 (n=70), 8 ± 8.8kg (n=46) (p<0.01 for all three time points), respectively. Percent excess weight loss (%EWL) at 12 months was 20.2% ± 10. In a meta-analysis that included 330 patients (n=130 our series and n=200 published in the literature) (Table 1), the pooled weight loss at 12 months using a random effects model was 8.3kg [95% CI 5.9-10.7] with acceptable heterogeneity (Q value = 5.1, I2 60.9). No serious device or treatment-related adverse events were reported and all procedures done in the outpatient setting Conclusion: TORe with a full thickness endoscopic suturing device is a safe and effective technique with durable weight loss. Given the morbidity and cost of revision surgery, TORe should be considered the initial intervention of choice for post RYGB weight-regain patients.
Su2041 ENDOSCOPIC MANAGEMENT OF GASTRIC LEAKS AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY, BY INTERNAL DRAINAGE WITH DOUBLE PIGTAIL STENT: BARTOLI PROCEDURE Constance Deschepper, Lionel Rebibo, Jean Philippe Le Mouel, Adrien Wacrenier, Franck Brazier, Mathurin Fumery, Richard Delcenserie, Cyril Cosse, Abdennaceur Dhahri, Henri Thiebault, Jean Marc Regimbeau, Jean-Louis Dupas, Eric Nguyen-Khan, Sami Hakim Background : Gastric leak (GL) after sleeve gastrectomy (SG) is the main early postoperative complication, reported in about 2.5% of patients. There is no consensus on the management of these fistula. We aimed to evaluate the efficacy and safety of internal endoscopic drainage of GL after SG by double pigtail stent (DPS). Methods : Between December 2009 and March 2016 (Total Period, TP), all patients with GL after SG initially treated by DPS were consecutively included and retrospectively analyzed. Before the establishement of a standardized technique after January 2014 (Period 2, P2), different modalities of endoscopic management by DPS were evaluated between December 2009 and December 2013 (Period 1, P1). The primary outcome was to evaluate the efficacy of the internal drainage by DPS during the TP, and to compare P1 and P2 periods. Efficacy was defined by refeeding without any abdominal collection, sepsis, endoscopic prothesis and external drainage module. Results : Eighty-two patients were included, 34 for P1 and 48 for P2. The median follow up after GL diagnosis was 64 days (extremes, 25-412). Endoscopic drainage by DPS was effective in 79.3% of patients (n=65) for TP, 67.7 % (n=23) for P1 and 87.5% (n=42) for P2 (p= 0.028). Radical surgery rate after endoscopic treatment failure was 3.7 %(n=3) during the total period. Median duration to fistula healing was 58 days ( 18-204) for the TP, 70 days (24-363) for P1 and 48.5 days (18-125) for P2 (p=0.003). Endoscopic complications were observed in 20.7% of patients (n=17) for the TP, with a migration rate of 17.1% (n=14) and a perforation rate of 3.6% (n=3). After migration, new endoscopic procedure was needed in 57.1 % (n=8) of cases. Median number of procedure per patients was 2 (1-5) for TP, 3 (1-5) for P1 and 2 (1-5) for P2 (p=0.0012). Median hospitalization duration for the TP, P1 and P2 were respectively, 16 days (3-87), 20 days (7-87) and 14.5 days (3-42) (p=0.019). Rate of hospitalization in intensive care unit for the TP, P1 and P2 were respectively, 24.6 % (n=16), 39.1% (n=9) and 16.6 %( n=7) (p=0.04). For the TP, median duration of ablation of the external drainage module after DPS drainage was 4 days (extremes, 1-17) and clinical tolerance of DPS was 97.6%. No deaths were observed during follow-up. Conclusions : This is the largest cohort of patients with GL after SG. Management of these patients by standardized endoscopic drainage with DPS is safe and effective, with a good tolerance. This technique is associated with easy management of external drainage modules, short hospitalization duration and a low rate of radical surgery.
S-637
AGA Abstracts
AGA Abstracts
INTRAGASTRIC BALLOON TREATMENT FOR OBESITY: MEDIUM, LONGTERM RESULTS, AND PATIENT SATISFACTION Yasser H. Shaib, Aline K. El Haddad, Assaad Soweid, Ala I. Sharara, Fady Daniel, Mohammad Rammal, Mahmoud Rahal