Endoscopic Surgery for Bariatric Revision After Weight Loss Failure
Official Title:
Apollo OverStitch for Bariatric Surgery Revision After Weight Loss FailureBasic Trial Information
| Phase | Type | Age | Sponsor | Protocol IDs | Status |
|---|---|---|---|---|---|
| N/A | Interventional | 18 Years and older | University of California, San Francisco |
EndoSurgery NCT01871896 |
Enrolling patients |
Study Design:
Principal Investigator
Professor of Surgery
Division of General Surgery
Director, UCSF Surgery Clerkship Program
Matthew Y.C. Lin, MD
[email protected]
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.
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
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.
Important
Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.