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OpenTrials
Completed

NCT Number: NCT01871896

Endoscopic Surgery for Bariatric Revision After Weight Loss Failure

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.

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Key information

Conditions

Morbid Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Suturing to Create Early Satiety

Device

Evaluating the efficacy of endoscopic suturing for weight loss.

Other names: Endoscopic Cerclage, Bariatric Surgery Revision, Apollo EndoStitch, Apollo OverTube

Primary outcomes

  1. Mean Weight Loss

    Time frame: 3 months after procedure

    We will track patient's weight after their endoscopic bariatric surgery.

Secondary outcomes

  1. Number of Participants With Resolved Co-morbidities

    Time frame: 2 years

    We will track the patient's weight loss and see if their obesity-related co-morbidities resolve.

  2. Tolerance

    Time frame: 2 years

    We will be monitoring patient's tolerance to this procedure and evaluate their satisfaction via a short questionnaire.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Apollo OverStitch for Bariatric Surgery Revision After Weight Loss Failure

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2013
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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