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Prospective Study of Ventral Hernia Repair

This study has been completed.
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00894582
First received: May 5, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

Immediate post-operative abdominal compartment syndrome is a feared complication after hernia repair in patients with a "loss of abdominal domain." Replacement of the viscera within an unyielding stiff abdominal wall may compromise the perfusion of the intestines, elevate the diaphragm, and interfere with ventilation. The components separation technique, used to repair these massive hernias, employs bilateral relaxing incisions in the external oblique muscle and fascia in order to approximate the rectus abdominis muscles in the midline. Reducing a large volume hernia into the abdominal cavity and primary closure of the abdominal wall should cause problems both with abdominal compartment pressure and with postoperative ventilation, but in the investigators' 13-year experience with over 250 cases, this has not been seen clinically, and the investigators sought to understand why. The investigators' hypothesis is that releasing the rectus muscles from the external obliques expands the intra-abdominal compartment, reclaims lost domain, and thus reduces abdominal pressure and respiratory problems. The investigators have previously reported increased abdominal volumes using the components separation technique in a retrospective series, but patients were not standardized for the collection of data, and no pulmonary function tests were obtained in that series (Hadad, in press). The purpose of this study was to prospectively analyze the effect of this surgical technique on abdominal volume and pulmonary function.


Condition Intervention
Ventral Hernia
Procedure: Components separation hernia repair

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Measurements of Intra-Abdominal Volume and Pulmonary Function After Repair of Massive Ventral Hernias With the Components Separation Technique

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in abdominal volume [ Time Frame: 3 months following hernia repair ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in pulmonary function [ Time Frame: 3 months following hernia repair ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: January 2007
Estimated Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Components separation hernia repair
    Components separation is one method currently employed for repair of massive ventral hernias. In this study we simply measured the volume of patients' abdomen (who were already undergoing this surgery) as well as their pulmonary function both pre and postoperatively.
Detailed Description:

With approval from the Institutional Review Board of Northwestern University, twenty-one patients with large ventral hernias were selected due to their large hernia size from a pool of 130 patients undergoing abdominal wall reconstruction from January 2007 to December 2008. No patients were excluded based on co-morbid conditions. One patient of the 21 selected was excluded because his preoperative CT scan that was performed at an outside institution was stored in an incompatible format for analysis. Another patient was excluded because it was decided intra-operatively that she could be repaired in a tension-free manner without components separation and was closed with mesh alone. Standard abdominal and pelvic CT scans and pulmonary function tests were performed immediately before hernia repair, and 3 months after repair. Pulmonary function tests were interpreted by blinded members of the Department of Pulmonology. Intra-operative peak airway pressure, bladder pressure, postoperative oxygen requirement, diagnosis of pneumonia, and any other cardio-respiratory complications were recorded on the remaining 19 patients. Routine patient demographics, clinical characteristics, postoperative course and incidence of recurrence were prospectively collected on all patients. Statistical analysis was performed in an intention-to-treat manner, using paired student's t-test where applicable.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • any patient with a large ventral hernia already scheduled to undergo ventral hernia repair with components separation technique

Exclusion Criteria:

  • any patient unwilling to comply with pre-operative pulmonary function testing, or postoperative pulmonary function testing or postoperative one-time abdominal CT scan
  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: NCT00894582

Locations
United States, Illinois
Division of Plastic and Reconstructive Surgery, Northwestern.edu
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
  More Information

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregory A. Dumanian, M.D., Division of Plastic and Reconstructive Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT00894582     History of Changes
Other Study ID Numbers: 0678-010
Study First Received: May 5, 2009
Last Updated: May 5, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
massive ventral hernia
abdominal volume
pulmonary function
components separation
abdominal compartments syndrome

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 27, 2014