Endoscopic Surgery for Bariatric Revision After Weight Loss Failure

Not Applicable

Completed

• Conditions: Morbid Obesity; Weight Loss
• Interventions: Device: Endoscopic Suturing to Create Early Satiety

• Registration Number: NCT01871896
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-05-11
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-07
• Study Start: 2014-01
• Primary Completion: 2022-06
• Study Completion: 2022-06
• Results First Submitted: 2023-06-22
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-25
• Last Update Submitted: 2023-07-25
• Results First Posted: 2023-08-16
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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Exclusion Criteria

• Esophageal Stricture
• Marginal Ulcer at the gastrojejunostomy anastomosis
• Non-compliance with bariatric follow-up
• Gastric ulcers
• Paraesophageal hernias

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Weight Gain	Endoscopic Suturing to Create Early Satiety	Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight.

Primary Outcome Measures

Name	Time	Method
Mean Weight Loss	3 months after procedure	We will track patient's weight after their endoscopic bariatric surgery.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Resolved Co-morbidities	2 years	We will track the patient's weight loss and see if their obesity-related co-morbidities resolve.
Tolerance	2 years	We will be monitoring patient's tolerance to this procedure and evaluate their satisfaction via a short questionnaire.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States