Laparoscopic Revision From Biliopancreatic Diversion to Gastric Bypass

NCT01041456 | Completed DMC

• 2 other identifiers: CMC IRB No. 2009016U1111-1113-0264
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to describe the clinical presentation, indications, and operative treatment as well as assess the morbidity, mortality, and overall performance of revisional GBP after either failed and/or complicated Biliopancreatic Diversion "BPD" for weight loss. With such information, we hope to determine what features might assist us in advancing our knowledge about mechanisms of failure after primary bariatric surgery, mechanism of action of revisional GBP, and performance of revisional GBP through traditional outcome measurements as well as identifying predictors of good or poor outcome after revisional GBP in this specific subpopulation.

Conditions

Metabolic and Nutritional Complications; Protein Malnutrition; Intestinal Malabsorptive Syndrome; Metabolic Bone Disease

Keywords

complicated biliopancreatic diversion; failed biliopancreatic diversion; revision gastric bypass; conversion bariatric surgery; revision bariatric surgery; re-operative bariatric surgery; malabsorptive syndrome; protein malnutrition; metabolic bone disease

Outcome Measures

Primary Outcomes (2)

• Morbidity and mortality

  at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 8 years

• Weight loss expressed as Body Mass Index and Percentage of excess weight loss

  at 6 months, 1 year and annually thereafter for up to 8 years

Secondary Outcomes (4)

• Trend in comorbidities

  at 6 months, 1 year, and annually thereafter for up to 8 years

• Symptom resolution

  at 6 months, 1 year, and annually thereafter for up to 8 years

• Length of operative time which is defined as the time duration of operation measured in minutes from the first skin incision to the final closure of the skin incision

  It is measured in minutes from the first skin incision to the final closure of the skin incision at the time of revisional surgery under study. It is a transoperative measure of outcome of the surgery under study

• Length of Hospital Stay which is a measured of surgical recovery quantified and reported in days. It is a hospital pre-discharge traditional measure of outcome

  It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study

Study Arms (1)

complicated and/or failed BPD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred with severe, persistent and/or recurrent metabolic/nutritional complications after open biliopancreatic diversion for clinically severe obesity underwent either laparoscopic or open conversion to Roux-en-Y gastric bypass. Intractability after interdisciplinary optimized medical therapy for metabolic and/or nutritional complications warranted surgical management.

You may qualify if:

• Patients status post biliopancreatic diversion with any combination of the following severe late complications:
• Metabolic and/or nutritional BPD-related complications.
• Excessive weight loss
• Poor weight loss, either Inadequate initial weight loss or Weight recidivism
• Intolerable intestinal malabsorptive symptoms without severe malnutrition
• Undergoing either open or laparoscopic conversion to Roux-en-Y gastric bypass (RYGB) surgery.

You may not qualify if:

• Any other type of revision or conversion surgery.
• Adequate response to medical management of metabolic and nutritional complications after previous BPD
• missing records and/or unreachable patients with scant information for analysis

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Fresno Center for Medical Education and Research

Fresno, California, 93701, United States

Location

Related Publications (71)

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Related Links

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MeSH Terms

Conditions

Kwashiorkor; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases

Study Officials

• Francisco M Tercero, MD

  Research Associate, University of California San Francisco

  STUDY DIRECTOR

• Kelvin D Higa, MD

  Professor of Surgery, University of California San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2009
• First Posted: December 31, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 1, 2010

Record last verified: 2009-12

Locations

US (1)