Prospective Study of Ventral Hernia Repair
Completed
Conditions studied: Ventral Hernia
In brief
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.
Key facts
- Study ID
- NCT00894582
- Run by
- Northwestern University
- People needed
- 21
- Starts
- 2007-01-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2009-05-07
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- any patient with a large ventral hernia already scheduled to undergo ventral hernia repair with components separation technique
You may not qualify if…
- any patient unwilling to comply with pre-operative pulmonary function testing, or postoperative pulmonary function testing or postoperative one-time abdominal CT scan
Where it is running
- Division of Plastic and Reconstructive Surgery, Northwestern.edu — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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