CClinicalTrials.gg
CompletedNCT01040377IIWLUpdated Dec 29, 2009

Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss

An observational study in Inadequate Initial Weight Loss and Persistent Clinically Severe Obesity, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-12-29.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
42
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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).

02

Conditions studied

  • Inadequate Initial Weight Loss
  • Persistent Clinically Severe Obesity

Keywords

  • Inadequate Initial Weight Loss
  • Inadequate weight loss
  • Poor weight loss
  • Failed gastric bypass
  • Revision gastric bypass
03

In context

Obesity, Morbid

922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.

This study's enrollment of 42 is below the median of 78 across 306 observational studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients that underwent laparoscopic revision gastric bypass after previously failed Roux-en-Y gastric bypass "RYGB" with an Inadequate initial weight loss "IIWL" pattern.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
42 participants (actual)

Groups and cohorts

  • Inadequate initial weight loss after gastric bypass
06

What researchers measure

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

07

Study locations

1 site
  • UCSF Fresno Center for Medical Education and Research
    Fresno, California 93701, United States
08

References and documents

Publications

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01040377
Lead sponsor
University of California, San Francisco
First posted
Dec 29, 2009
Start date
Oct 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Dec 29, 2009

Study contacts

Francisco M Tercero, MD
study director · Research Associate, University of California San Franisco
Kelvin D Higa, MD
principal investigator · Professor of Surgery, University of California San Francisco

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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