Clinical trial NCT01040377: Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss
Official title: Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss After Gastric Bypass: Intermediate Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-12-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Weight loss expressed as Body Mass Index and Percentage excess weight loss
timeFrame: at the lowest weight loss point and at last follow-up
measure: Comorbidity status
timeFrame: throughout follow-up
measure: Health-related Quality of Life (HR-QoL)
timeFrame: at last follow-up
measure: Subjective satisfaction
timeFrame: at the last follow-up
measure: Morbidity and mortality
timeFrame: throughout follow-up
Secondary outcomes:
measure: Failure/success rate
timeFrame: at yearly intervals throughout follow-up
measure: Metabolic and nutritional variables
timeFrame: throughout follow-up
Other outcomes:
Locations:
city: Fresno
country: United States
facility: UCSF Fresno Center for Medical Education and Research
state: California
Study officials:
affiliation: Research Associate, University of California San Franisco
name: Francisco M Tercero, MD
role: STUDY_DIRECTOR
affiliation: Professor of Surgery, University of California San Francisco
name: Kelvin D Higa, MD
role: PRINCIPAL_INVESTIGATOR
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