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Prospective Study of Ventral Hernia Repair

NCT00894582 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2009-05-07

No results posted yet for this 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.

Conditions

  • Ventral Hernia

Interventions

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.

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00894582 on ClinicalTrials.gov