Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01040377

Acronym

IIWL

Enrollment

Registered

2009-12-29

Start date

2009-10-31

Completion date

2009-12-31

Last updated

2009-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Health-related Quality of Life (HR-QoL)	at last follow-up
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
Morbidity and mortality	throughout follow-up
Subjective satisfaction	at the last follow-up

Secondary

Measure	Time frame
Metabolic and nutritional variables	throughout follow-up
Failure/success rate	at yearly intervals throughout follow-up

Countries

United States

Outcome results