Prospective Study of Ventral Hernia Repair

Ventral Hernia Clinical Trial

Official title:

Prospective Measurements of Intra-Abdominal Volume and Pulmonary Function After Repair of Massive Ventral Hernias With the Components Separation Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894582
• Other study ID #: 0678-010
• Status: Completed
• Phase: N/A
• First received: May 5, 2009
• Last updated: May 5, 2009
• Start date: January 2007
• Est. completion date: December 2008

Study information

• Verified date: May 2009
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

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.

Locations

Country	Name	City	State
United States	Division of Plastic and Reconstructive Surgery, Northwestern.edu	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in abdominal volume		3 months following hernia repair	No
Secondary	Change in pulmonary function		3 months following hernia repair	No