Endoscopic Surgery for Bariatric Revision After Weight Loss Failure

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    20
  • sponsor
    University of California, San Francisco
Updated on 21 May 2021
gastrectomy
metabolic disorders
bariatric surgery
gastric bypass
morbid obesity
gastrojejunostomy
roux-en-y
sleeve gastrectomy

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.

Details
Condition severe obesity, Morbid obesity, Weight Loss
Treatment Endoscopic Suturing to Create Early Satiety
Clinical Study IdentifierNCT01871896
SponsorUniversity of California, San Francisco
Last Modified on21 May 2021

Eligibility

Yes No Not Sure

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
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