Clinical Trial: Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: One-stage Laparoscopic Revision of Failed and/or Complicated Jejunoileal Bypass to Roux-en-Y Gastric Bypass

Brief Summary:

This study objectives are the following.

  • To describe the updated clinical presentation, indications, and multidisciplinary medical management of patients with a failed and/or complicated jejunoileal bypass (JIB).
  • To analyze the feasibility, safety, and efficacy of one-stage laparoscopic re-operative gastric bypass surgery for failed and/or complicated Jejunoileal bypass (JIB) for weight loss.
  • To determine what factors or strategies are associated with a successful outcome. In particular, the completion of the surgery in one stage with a laparoscopic approach.

Detailed Summary:

The epidemic of overweight and obesity in the United States of America along with its comorbidities continues to expand. Bariatric surgery has demonstrated to be the most effective and sustained method to control severe obesity and its comorbidities. For instance, type 2 diabetes mellitus was completely resolved in 76.8 percent, systemic arterial hypertension was resolved in 61.7 percent, dyslipidemia improved in 70 percent, and obstructive sleep apnea hypopnea syndrome was resolved in 85.7 percent. Furthermore, bariatric surgery significantly increases life expectancy (89 percent) and decreases overall mortality (30 to 40 percent), particularly deaths from diabetes, heart disease, and cancer. Lastly, preliminary evidence about downstream savings associated with bariatric surgery offset the initial costs in 2 to 4 years8.

Since 1998, there has been a substantially progressive increase in bariatric surgery. In 2005, the American Society of Metabolic and Bariatric Surgery "ASMBS" reported that 81 percent of bariatric procedures were approached laparoscopically. 205,000 people, in 2007, had bariatric surgery in the United States from which approximately 80 percent of these were Gastric Bypass. Moreover, there is a mismatch between eligibility and receipt of bariatric surgery with just less than 1 percent of the eligible population being treated for morbid obesity through bariatric surgery. Along with the increasing number of elective primary weight loss procedures, up to 20 percent of post RYGB patients cannot sustain their weight loss beyond 2 to 3 years after the primary bariatric procedure. Thus, revisional surgery for poor weight loss and re-operations for technical or mechanical complications will rise in a parallel manner.

Regardless of being an effective treatment of morbid obesity, JIB was abandoned in the e
Sponsor: University of California, San Francisco

Current Primary Outcome:

  • Morbidity and mortality [ Time Frame: throughout follow-up ]
  • Weight loss expressed as Body Mass Index and Percentage excess weight loss [ Time Frame: throughout follow-up ]
  • Remission or improvement of symptoms and JIB-related complications [ Time Frame: throughout follow-up ]
  • Remission or improvement of other comorbidities [ Time Frame: throughout follow-up ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Operative time [ Time Frame: transoperatively ]
  • conversion to open approach [ Time Frame: transoperatively ]
  • Hospital stay [ Time Frame: same hospitalization ]


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: December 26, 2009
Date Started: December 2008
Date Completion:
Last Updated: December 28, 2009
Last Verified: December 2009