Laparoscopic Revision From Biliopancreatic Diversion to Gastric Bypass (BPD-to-RYGB)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01041456
First received: December 26, 2009
Last updated: December 31, 2009
Last verified: December 2009
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Another Revisional Strategy to Address Severe Late Complications After Previous Biliopancreatic Diversion for Obesity: Major Revision From Standard Biliopancreatic Diversion to Proximal Roux-en-Y Gastric Bypass

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Morbidity and mortality [ Time Frame: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 8 years ] [ Designated as safety issue: Yes ]
  • Weight loss expressed as Body Mass Index and Percentage of excess weight loss [ Time Frame: at 6 months, 1 year and annually thereafter for up to 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trend in comorbidities [ Time Frame: at 6 months, 1 year, and annually thereafter for up to 8 years ] [ Designated as safety issue: No ]
  • Symptom resolution [ Time Frame: at 6 months, 1 year, and annually thereafter for up to 8 years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: March 2009
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
complicated and/or failed BPD

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041456

Locations
United States, California
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 Francisco
Principal Investigator: Kelvin D Higa, MD Professor of Surgery, University of California San Francisco
  More Information

Additional Information:
Publications:
Scopinaro N, Papadia F, Marinari G, et al. (2007). Biliopancreatic diversion. In Surgical Management of Obesity (pp.239-51). Philadelphia: Saunders.
Ren CJ. (2004). Laparoscopic malabsorption procedures: Complications. In Laparoscopic Bariatric Surgery (pp. 343-53). Philadelphia: Lippincott Williams & Wilkins.
Scopinaro N. (2008). Biliopancreatic diversion: Revisional surgery. In obesity Surgery Principles and Practice (pp.277-83). New York: McGraw Hill.

Responsible Party: Kelvin D Higa, MD, FACS; FASMBS; Professor of Surgery, University of California San Francisco, UCSF Fresno / ALSA Medical Group, Inc. Minimally Invasive Surgery Program
ClinicalTrials.gov Identifier: NCT01041456     History of Changes
Other Study ID Numbers: CMC IRB No. 2009016, U1111-1113-0264
Study First Received: December 26, 2009
Last Updated: December 31, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
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

Additional relevant MeSH terms:
Syndrome
Malnutrition
Nutrition Disorders
Bone Diseases
Bone Diseases, Metabolic
Kwashiorkor
Disease
Pathologic Processes
Musculoskeletal Diseases
Protein-Energy Malnutrition
Protein Deficiency
Deficiency Diseases

ClinicalTrials.gov processed this record on September 30, 2014