Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass (JIB-to-RYGB)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01040533
First received: December 26, 2009
Last updated: December 28, 2009
Last verified: December 2009
  Purpose

This study objectives are the following.

  • To describe the updated clinical presentation, indications, and multidisciplinary medical management of patients with a failed and/or complicated jejunoileal bypass (JIB).
  • To analyze the feasibility, safety, and efficacy of one-stage laparoscopic re-operative gastric bypass surgery for failed and/or complicated Jejunoileal bypass (JIB) for weight loss.
  • To determine what factors or strategies are associated with a successful outcome. In particular, the completion of the surgery in one stage with a laparoscopic approach.

Condition
Clinically Severe Obesity
Metabolic Complications After Jejunoileal Bypass
Nutritional Complications After Jejunoileal Bypass
Obesity Recidivism
Inadequate Initial Weight Loss
Intestinal Malabsorptive Syndrome
Protein Malnutrition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: One-stage Laparoscopic Revision of Failed and/or Complicated Jejunoileal Bypass to 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: throughout follow-up ] [ Designated as safety issue: Yes ]
  • Weight loss expressed as Body Mass Index and Percentage excess weight loss [ Time Frame: throughout follow-up ] [ Designated as safety issue: No ]
  • Remission or improvement of symptoms and JIB-related complications [ Time Frame: throughout follow-up ] [ Designated as safety issue: No ]
  • Remission or improvement of other comorbidities [ Time Frame: throughout follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Operative time [ Time Frame: transoperatively ] [ Designated as safety issue: No ]
  • conversion to open approach [ Time Frame: transoperatively ] [ Designated as safety issue: No ]
  • Hospital stay [ Time Frame: same hospitalization ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Failed / complicated jejunoileal bypass

  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 who underwent laparoscopic revision of JIB to Roux-en-Y gastric bypass (RYGB) for poor weight loss or JIB-related late complications were analyzed. Failed or JIB-related late complications, mostly metabolic, were considered for surgical intervention after optimized medical multidisciplinary management

Criteria

Inclusion Criteria:

  • Met NIH criteria for weight loss surgery with poor weight loss after JIB
  • Intractable, severe and/or recurrent JIB-related late complications after optimized medical management
  • Laparoscopic approach for primary revisional bariatric surgery

Exclusion Criteria:

  • Any other type of revisional bariatric procedure
  • Open approach for revision surgery
  • 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: NCT01040533

Locations
United States, California
UCSF Fresno Center for Medical Education and Research, Department of Surgery
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:

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: NCT01040533     History of Changes
Other Study ID Numbers: CMC IRB No. 2008085, U1111-1112-9885
Study First Received: December 26, 2009
Last Updated: December 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Failed jejunoileal bypass
Complicated jejunoileal bypass
Revision gastric bypass
Revisional surgery
Reoperations
Metabolic and nutritional complications

Additional relevant MeSH terms:
Kwashiorkor
Obesity
Obesity, Morbid
Weight Loss
Malnutrition
Nutrition Disorders
Protein-Energy Malnutrition
Protein Deficiency
Deficiency Diseases
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 28, 2014