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Internal Hernias After Laparoscopic Gastric Bypass (IHafterLRYGB)

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.
ClinicalTrials.gov Identifier: NCT01040364
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : September 24, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
The main goal of this study is to describe the trends in the incidence rate of internal hernia presentation after different modifications of the mesenteric closure technique after primary laparoscopic Roux-en-Y gastric bypass (RYGB) surgery from 1997-2009.

Condition or disease
Internal Hernia Mesocolic Hernia Petersen´s Hernia Jejunojejunostomy Hernia Bowel Obstruction Ischemic Bowel

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Study Design

Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence of Internal Hernias After Laparoscopic Roux-en-Y Gastric Bypass Over the Last Decade: 1997 to 2008
Study Start Date : May 2009
Primary Completion Date : June 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Groups and Cohorts

Interna hernia after primary gastric bypass

Outcome Measures

Primary Outcome Measures :
  1. Closure technique for mesocolic defect: 1- non-closure, 2- running with absorbable material, 3- interrupted with non-absorbable material, and 4- running with non-absorbable [ Time Frame: throughout follow-up ]
  2. recurrence of symptomatic mesocolic internal hernia [ Time Frame: throughout follow-up ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting with internal hernia after different modifications of the mesenteric closure technique after Primary Laparoscopic RYGB surgery from 1997-2009.

Inclusion Criteria:

  • patient status post primary laparoscopic standard RYGB surgery who underwent internal hernia reduction and repair with any or the combination of the following:

    • closure of synchronous mesocolic or mesenteric space defects without incarcerated bowel
    • conversion to open (laparotomy)
    • small bowel resection with or without reversal
  • status post primary laparoscopic standard RYGB surgery with incidental finding of internal hernia space defect with or without bowel through the defect

Exclusion Criteria:

  • any other type of re-operative surgery after primary standard RYGB
  • patient age < 18 years
  • missing records and/or unreachable patients with scant information for analysis
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01040364

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
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:
http://www.asbs.org/htm/Private/resolution.html. American Society of Metabolic and Bariatric Surgeons.

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01040364     History of Changes
Other Study ID Numbers: CMC IRB No. 2009024
U1111-1113-0414 ( Other Identifier: World Health Organization, Universal Trial Number )
First Posted: December 29, 2009    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013

Keywords provided by University of California, San Francisco:
Internal hernia
Mesocolic hernia
Petersen´s hernia
Jejunojejunostomy hernia
Bowel obstruction
Ischemic bowel
Complication after gastric bypass
Re-operative bariatric surgery
Chronic pain after gastric bypass

Additional relevant MeSH terms:
Intestinal Obstruction
Hernia, Abdominal
Pathological Conditions, Anatomical
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases