Prospective Study of Ventral Hernia Repair

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: NCT00894582
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : May 7, 2009
Information provided by:
Northwestern University

Brief Summary:
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 or disease Intervention/treatment
Ventral Hernia Procedure: Components separation hernia repair

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.

Study Type : Observational
Actual Enrollment : 21 participants
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
Study Start Date : January 2007
Actual Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Change in abdominal volume [ Time Frame: 3 months following hernia repair ]

Secondary Outcome Measures :
  1. Change in pulmonary function [ Time Frame: 3 months following hernia repair ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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): NCT00894582

United States, Illinois
Division of Plastic and Reconstructive Surgery,
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gregory A. Dumanian, M.D., Division of Plastic and Reconstructive Surgery, Northwestern University Identifier: NCT00894582     History of Changes
Other Study ID Numbers: 0678-010
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: May 7, 2009
Last Verified: May 2009

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

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