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Trial record 7 of 12 for:    16234497 [PUBMED-IDS]

Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass (JIB-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: NCT01040533
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : December 29, 2009
Information provided by:
University of California, San Francisco

Brief Summary:

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

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 4 participants
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
Study Start Date : December 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Failed / complicated jejunoileal bypass

Primary Outcome Measures :
  1. Morbidity and mortality [ Time Frame: throughout follow-up ]
  2. Weight loss expressed as Body Mass Index and Percentage excess weight loss [ Time Frame: throughout follow-up ]
  3. Remission or improvement of symptoms and JIB-related complications [ Time Frame: throughout follow-up ]
  4. Remission or improvement of other comorbidities [ Time Frame: throughout follow-up ]

Secondary Outcome Measures :
  1. Operative time [ Time Frame: transoperatively ]
  2. conversion to open approach [ Time Frame: transoperatively ]
  3. Hospital stay [ Time Frame: same hospitalization ]

Information from the National Library of Medicine

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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 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

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

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): NCT01040533

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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
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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:

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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: NCT01040533     History of Changes
Other Study ID Numbers: CMC IRB No. 2008085
U1111-1112-9885 ( Other Identifier: World Health Organization, Universal Trial Number )
First Posted: December 29, 2009    Key Record Dates
Last Update Posted: December 29, 2009
Last Verified: December 2009

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

Additional relevant MeSH terms:
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Weight Loss
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes
Severe Acute Malnutrition