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OpenTrials
Completed

NCT Number: NCT01040377

Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss

The main aim of this study is to analyze and report traditional, patient-centered, and composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for inadequate initial weight loss.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Fresno Center for Medical Education and Research

Fresno, California, 93701, United States

About this study

There is lack of standardization of primary and revisional bariatric surgery compounded by a scant long-term outcome data. The treatment of inadequate weight loss, weight recidivism, and most severe technical complications after primary bariatric surgery remains refractory to non-operative treatment. Failure rates have been reported up to 20% and 35% for the morbidly obese (MO) and super obese (SO), respectively at 2 to 3 years after surgery. The indication for further surgical intervention remains controversial, as does what type of revisional procedure, both operative and endoscopic, to recommend. Furthermore, there is no standardization of the limb lengths, pouch size or the use of prosthetic reinforcement. Therefore the approach to these patients must be as individualized as their original operations. We formally analyze our experience with all laparoscopic revisional strategies for Inadequate Initial Weight Loss after failed Roux-en-Y gastric bypass(RYGB).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • laparoscopic revisional RYGB for failed RYGB with IIWL or non-responders pattern

Exclusion criteria

  • failed RYGB with a WR pattern
  • patients with prior major bariatric conversion or esophago-gastric surgeries
  • RYGB patients revised by an open surgical approach
  • RYGB patients who underwent laparoscopic revisional RYGB surgery somewhere else and continue their follow-up care with program
  • missing records and/or unreachable patients with scan information for analysis

Treatment and study plan

Primary outcomes

  1. Weight loss expressed as Body Mass Index and Percentage excess weight loss

    Time frame: at the lowest weight loss point and at last follow-up

  2. Comorbidity status

    Time frame: throughout follow-up

  3. Health-related Quality of Life (HR-QoL)

    Time frame: at last follow-up

  4. Subjective satisfaction

    Time frame: at the last follow-up

  5. Morbidity and mortality

    Time frame: throughout follow-up

Secondary outcomes

  1. Failure/success rate

    Time frame: at yearly intervals throughout follow-up

  2. Metabolic and nutritional variables

    Time frame: throughout follow-up

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss After Gastric Bypass: Intermediate Results

Acronym: IIWL

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 29, 2009
Registry last updated
Dec 29, 2009

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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