Working… Menu
Trial record 15 of 27 for:    15479938 [PUBMED-IDS]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01041456
Recruitment Status : Completed
First Posted : December 31, 2009
Last Update Posted : January 1, 2010
Information provided by:
University of California, San Francisco

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.

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

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 10 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

complicated and/or failed BPD

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Trend in comorbidities [ Time Frame: at 6 months, 1 year, and annually thereafter for up to 8 years ]
  2. Symptom resolution [ Time Frame: at 6 months, 1 year, and annually thereafter for up to 8 years ]
  3. 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 ]
  4. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01041456

Layout table for location information
United States, California
UCSF Fresno Center for Medical Education and Research
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
Layout table for investigator information
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

Additional Information:
Publications: American Society of Metabolic and Bariatric Surgeons.
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.

Layout table for additonal information
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 Identifier: NCT01041456     History of Changes
Other Study ID Numbers: CMC IRB No. 2009016
U1111-1113-0264 ( Other Identifier: World Health Organization, Universal Trial Number )
First Posted: December 31, 2009    Key Record Dates
Last Update Posted: January 1, 2010
Last Verified: December 2009
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:
Layout table for MeSH terms
Bone Diseases
Bone Diseases, Metabolic
Nutrition Disorders
Musculoskeletal Diseases
Metabolic Diseases
Severe Acute Malnutrition