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Morbid obesity and its associated metabolic diseases are on the rise in the United States. Currently, the best treatment for obesity is bariatric surgery where both roux-en-Y gastric bypass and sleeve gastrectomy offer substantial weight loss. Unfortunately, 20% of patients who undergo bariatric surgery fail to lose enough weight defined as less than 50% of excess body weight loss or regain of weight. For those patients who fail to lose weight after bariatric surgery and have failed maximal medical therapy and diet supervision, the treatment is re-operation and revision. Re-operation of the abdomen carries significant postoperative morbidity and mortality. The investigators propose to use the Apollo OverStitch endoscopic suturing device that has already been approved by the FDA as an option for bariatric surgery revision without having to re-operate on the patient. The investigators believe that the endoscopic technique may be able to provide weight loss without having to re-operate on the patient.
The most effective weight loss procedures in the United States are both roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG)where the majority are performed laparoscopically. Estimated excess body weight loss (EBWL) is >50% at the end of one year. However, nearly 20% of patients fail to meet the estimated EBWL or they may experience weight gain recidivism. The first step is nutritional counseling, medically supervised diets, and medical therapy. Surgery would be for those who still fail to lose weight despite the aforementioned efforts.
It is hypothesized that failure of weight loss for RYGB is gastrojejunostomy (GJ) dilation defined as >2 cm. Surgical treatment would require revision of this dilation. Unfortunately many of these revision procedures cannot be done laparoscopically given dense intra-abdominal adhesions. This will require conversion to an open surgery in a morbidly obese patient thus raising postoperative morbidity and mortality estimated to range between 15%-50%.
The investigators propose to use the endoscopic suturing device designed by Apollo EndoSurgery to decrease the GJ dilation to 5-6 mm thus causing restriction, delayed food transit time, and promote early satiety. These efforts will limit overall caloric intake thereby promoting weight loss.
It is thought that patients with previous SG may have a dilation of their stomach. The investigators propose a pyloric cerclage using the Apollo EndoSurgery suturing device by decreasing the opening of the pylorus thus achieving the same goals that the investigators proposed above with RYGB revision.
Endoscopic procedures are same day procedures with little morbidity and mortality when compared to laparoscopic or open bariatric surgery revision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Gain | Experimental | Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Suturing to Create Early Satiety | Device | Evaluating the efficacy of endoscopic suturing for weight loss. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Weight Loss | We will track patient's weight after their endoscopic bariatric surgery. | 3 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Resolved Co-morbidities | We will track the patient's weight loss and see if their obesity-related co-morbidities resolve. | 2 years |
| Tolerance | We will be monitoring patient's tolerance to this procedure and evaluate their satisfaction via a short questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley J Rogers, MD | University of California, San Francisco | Principal Investigator |
| Jonathan T Carter, MD | University of California, San Francisco | Principal Investigator |
| John P Cello, MD | University of California, San Francisco | Principal Investigator |
| Matthew Lin, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23567348 | Background | Thompson CC, Chand B, Chen YK, DeMarco DC, Miller L, Schweitzer M, Rothstein RI, Lautz DB, Slattery J, Ryan MB, Brethauer S, Schauer P, Mitchell MC, Starpoli A, Haber GB, Catalano MF, Edmundowicz S, Fagnant AM, Kaplan LM, Roslin MS. Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology. 2013 Jul;145(1):129-137.e3. doi: 10.1053/j.gastro.2013.04.002. Epub 2013 Apr 5. | |
| 22258299 |
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24 patients were recruited 23 underwent the proposed procedure
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight. Endoscopic Suturing to Create Early Satiety: Evaluating the efficacy of endoscopic suturing for weight loss. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Weight Gain | Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight. Endoscopic Suturing to Create Early Satiety: Evaluating the efficacy of endoscopic suturing for weight loss. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Weight Loss | We will track patient's weight after their endoscopic bariatric surgery. | Posted | Mean | Full Range | Pounds | 3 months after procedure |
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Up to 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Weight Gain | Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight. Endoscopic Suturing to Create Early Satiety: Evaluating the efficacy of endoscopic suturing for weight loss. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leak | Gastrointestinal disorders | Systematic Assessment | The patient sustained a small leak from the revision. This was identified the day after surgery and treated with IV antibiotics. She recovered 4 days afterwards and was discharged. We followed her for 3 hours and she has been doing well. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment | Patient's revision was very tight. We dilated her and it resolved. No long term issues. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Lin | University of California San Francisco | 415 353 2161 | Matthew.Lin@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2017 | Jun 22, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| 2 years |
| Background |
| Deylgat B, D'Hondt M, Pottel H, Vansteenkiste F, Van Rooy F, Devriendt D. Indications, safety, and feasibility of conversion of failed bariatric surgery to Roux-en-Y gastric bypass: a retrospective comparative study with primary laparoscopic Roux-en-Y gastric bypass. Surg Endosc. 2012 Jul;26(7):1997-2002. doi: 10.1007/s00464-011-2140-0. Epub 2012 Jan 19. |
| 22054158 | Background | Kellogg TA. Revisional bariatric surgery. Surg Clin North Am. 2011 Dec;91(6):1353-71, x. doi: 10.1016/j.suc.2011.08.004. |
| 21902955 | Background | deWolfe MA, Bower CE. Using the StomaphyX(TM) endoplicator to treat a gastric bypass complication. JSLS. 2011 Jan-Mar;15(1):109-13. doi: 10.4293/108680811X13022985131570. |
| 21640665 | Background | Thompson CC, Jacobsen GR, Schroder GL, Horgan S. Stoma size critical to 12-month outcomes in endoscopic suturing for gastric bypass repair. Surg Obes Relat Dis. 2012 May-Jun;8(3):282-7. doi: 10.1016/j.soard.2011.03.014. Epub 2011 Apr 19. |
| 21474389 | Background | Raman SR, Holover S, Garber S. Endolumenal revision obesity surgery results in weight loss and closure of gastric-gastric fistula. Surg Obes Relat Dis. 2011 May-Jun;7(3):304-8. doi: 10.1016/j.soard.2011.01.045. Epub 2011 Feb 22. |
| 22055390 | Background | Heneghan HM, Yimcharoen P, Brethauer SA, Kroh M, Chand B. Influence of pouch and stoma size on weight loss after gastric bypass. Surg Obes Relat Dis. 2012 Jul-Aug;8(4):408-15. doi: 10.1016/j.soard.2011.09.010. Epub 2011 Sep 23. |
| 21533520 | Background | Yimcharoen P, Heneghan HM, Singh M, Brethauer S, Schauer P, Rogula T, Kroh M, Chand B. Endoscopic findings and outcomes of revisional procedures for patients with weight recidivism after gastric bypass. Surg Endosc. 2011 Oct;25(10):3345-52. doi: 10.1007/s00464-011-1723-0. Epub 2011 Apr 30. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Participants With Resolved Co-morbidities | We will track the patient's weight loss and see if their obesity-related co-morbidities resolve. | Posted | Count of Participants | Participants | 2 years |
|
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| Secondary | Tolerance | We will be monitoring patient's tolerance to this procedure and evaluate their satisfaction via a short questionnaire. | Data were not collected for this outcome measure. Milestone visit dates at which surveys were going to be provided were not followed through by patients resulting in the lack of data collected. | Posted | 2 years |
|
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| 1 |
| 24 |
| 1 |
| 24 |
| 1 |
| 24 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |