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

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

This study is currently recruiting participants.
Verified by University Hospital, Ghent, December 2007

Sponsored by:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00498810

Purpose

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	Intervention
Incisional Hernia	Procedure: complete repair Procedure: partial repair of the abdominal wall

MedlinePlus related topics:

Hernia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

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

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

recurrence rate [ Time Frame: 1 year ]

Secondary Outcome Measures:

Perioperative morbidity rate
Postoperative pain
Long term complication rate
Recurrence rate [ Time Frame: 3 years ]

Estimated Enrollment:

160

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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All patients with mesh placed intra-abdominally during surgery have to be withdrawn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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498810

Contacts


Contact: Frederik Berrevoet, MD	0032(0)9/240.48.92	frederik.berrevoet@ugent.be

Locations


Belgium
	University Hospital Ghent	Recruiting
	Ghent, Belgium, 9000
	Contact: Frederik Berrevoet, MD 0032(0)9/240.48.92 frederik.berrevoet@ugent.be
	Principal Investigator: Frederik Berrevoet, MD

Sponsors and Collaborators

University Hospital, Ghent

Investigators


Principal Investigator:	Frederik Berrevoet, MD	University Hospital, Ghent

More Information

Website University Hospital Ghent This link exits the ClinicalTrials.gov site

Study ID Numbers:	2007/241
First Received:	July 9, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00498810
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Hernia

ClinicalTrials.gov processed this record on October 06, 2008