COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00498810
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Duration (Months): 4
• Patients Per Site Per Month: 39.9

Study Details

Study Description

Brief Summary

To compare the complete repair of the abdominal wall at the level of the former incision with only a partial repair at the level of the hernia in patients with an incisional hernia after median laparotomy in a prospective randomized trial.

Condition or Disease	Intervention/Treatment	Phase
Incisional Hernia	Procedure: complete repair; Procedure: partial repair of the abdominal wall	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Outcome Measures

Primary Outcome Measures

1. recurrence rate [1 year]

Secondary Outcome Measures

1. Perioperative morbidity rate []

2. Postoperative pain []

3. Long term complication rate []

4. Recurrence rate [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Written informed consent from the patient or his/her legal representative

• Incisional hernia requiring elective surgical repair

Exclusion Criteria:

• No written informed consent

• Emergency surgery (incarcerated hernia)

• All incisional or parastomal hernias not originating at the midline

• All recurrent hernias

• All patients with mesh placed intra-abdominally during surgery have to be withdrawn

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Frederik Berrevoet, MD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website University Hospital Ghent

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00498810
• Other Study ID Numbers: 2007/241
• First Posted: Jul 10, 2007
• Last Update Posted: Jan 28, 2011
• Last Verified: Jan 1, 2011

• Additional relevant MeSH terms: Hernia; Incisional Hernia

Study Results

No Results Posted as of Jan 28, 2011