IIWL: Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01040377

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inadequate Initial Weight Loss Persistent Clinically Severe Obesity

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).

Study Design

Study Type:

Observational

Actual Enrollment :

42 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Inadequate initial weight loss after gastric bypass

Outcome Measures

Primary Outcome Measures

Weight loss expressed as Body Mass Index and Percentage excess weight loss [at the lowest weight loss point and at last follow-up]
Comorbidity status [throughout follow-up]
Health-related Quality of Life (HR-QoL) [at last follow-up]
Subjective satisfaction [at the last follow-up]
Morbidity and mortality [throughout follow-up]

Secondary Outcome Measures

Failure/success rate [at yearly intervals throughout follow-up]
Metabolic and nutritional variables [throughout follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF Fresno Center for Medical Education and Research	Fresno	California	United States	93701

Sponsors and Collaborators

University of California, San Francisco

Investigators

Study Director: Francisco M Tercero, MD, Research Associate, University of California San Franisco
Principal Investigator: Kelvin D Higa, MD, Professor of Surgery, University of California San Francisco