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NCT00894582 · ClinicalTrials.gov registry record
Prospective Study of Ventral Hernia Repair
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 21
- Enrollment target
NCT00894582 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 21 participants.
The verdict
NCT00894582 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 21 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Components separation hernia repair
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00894582
The ClinicalTrials.gov registry entry for NCT00894582 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Components separation hernia repair is the first listed.
NCT00894582 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00894582 about?
NCT00894582 is a clinical study titled "Prospective Study of Ventral Hernia Repair". 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 interfer...
What is the current status of trial NCT00894582?
This trial is currently completed. The enrollment target is 21 participants. The study started on 2007-01. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00894582?
The interventions under investigation include: Components separation hernia repair (PROCEDURE).
Who is sponsoring clinical trial NCT00894582?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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