Laparoscopic Revision From Biliopancreatic Diversion to Gastric Bypass (BPD-to-RYGB)
This study has been completed.
Sponsor:
University of California, San Francisco
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
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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
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:
|
Bone Diseases Bone Diseases, Metabolic Kwashiorkor Malnutrition Musculoskeletal Diseases |
Protein-Energy Malnutrition Protein Deficiency Deficiency Diseases Nutrition Disorders |
ClinicalTrials.gov processed this record on June 13, 2013