Endoscopic Surgery for Bariatric Revision After Weight Loss Failure

Weight Loss Clinical Trial

Official title:

Apollo OverStitch for Bariatric Surgery Revision After Weight Loss Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871896
• Other study ID #: EndoSurgery
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: June 2022

Study information

• Verified date: July 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previous Roux-En-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)

• Failure to lose >50% of their excess body weight after 1 year

• Failure of weight loss despite maximal medical therapy and medically-supervised diets

Exclusion Criteria:

• Esophageal Stricture

• Marginal Ulcer at the gastrojejunostomy anastomosis

• Non-compliance with bariatric follow-up

• Gastric ulcers

• Paraesophageal hernias

Related Conditions & MeSH terms

• Body Weight
• Morbid Obesity
• Obesity, Morbid
• Weight Loss

Intervention

Device:
• Endoscopic Suturing to Create Early Satiety
Evaluating the efficacy of endoscopic suturing for weight loss.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

Kellogg TA. Revisional bariatric surgery. Surg Clin North Am. 2011 Dec;91(6):1353-71, x. doi: 10.1016/j.suc.2011.08.004. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Weight Loss	We will track patient's weight after their endoscopic bariatric surgery.	3 months after procedure
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.	2 years
Secondary	Tolerance	We will be monitoring patient's tolerance to this procedure and evaluate their satisfaction via a short questionnaire.	2 years