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Internal Hernias After Laparoscopic Gastric Bypass (IHafterLRYGB)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01040364
First received: December 26, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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
Internal Hernia
Mesocolic Hernia
Petersen´s Hernia
Jejunojejunostomy Hernia
Bowel Obstruction
Ischemic Bowel

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • recurrence of symptomatic mesocolic internal hernia [ Time Frame: throughout follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 220
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Interna hernia after primary gastric 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 presenting with internal hernia after different modifications of the mesenteric closure technique after Primary Laparoscopic RYGB surgery from 1997-2009.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040364

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:
"Click here for more information about the department sponsor´s web site"  This link exits the ClinicalTrials.gov site

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: NCT01040364     History of Changes
Other Study ID Numbers: CMC IRB No. 2009024, U1111-1113-0414
Study First Received: December 26, 2009
Last Updated: December 26, 2009
Health Authority: United States: Institutional Review Board

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:
Hernia
Intestinal Obstruction
Ischemia
Hernia, Abdominal
Pathological Conditions, Anatomical
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013