Prospective Study of Ventral Hernia Repair

NCT00894582 | Completed DMC

• 1 other identifier: 0678-010
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia

Keywords

massive ventral hernia; abdominal volume; pulmonary function; components separation; abdominal compartments syndrome

Outcome Measures

Primary Outcomes (1)

• Change in abdominal volume

  3 months following hernia repair

Secondary Outcomes (1)

• Change in pulmonary function

  3 months following hernia repair

Interventions

Components separation hernia repair PROCEDURE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Division of Plastic and Reconstructive Surgery, Northwestern.edu

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Agnew SP, Small W Jr, Wang E, Smith LJ, Hadad I, Dumanian GA. Prospective measurements of intra-abdominal volume and pulmonary function after repair of massive ventral hernias with the components separation technique. Ann Surg. 2010 May;251(5):981-8. doi: 10.1097/SLA.0b013e3181d7707b.

  PMID: 20395855 DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 7, 2009
• Study Start: January 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 7, 2009

Record last verified: 2009-05

Locations

US (1)