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NCT00498810 Clinical Trial

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

Incisional Hernia Clinical Trial

— COMPAC  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00498810
Other study ID # 2007/241
Secondary ID
Status Terminated
Phase N/A
First received July 9, 2007
Last updated January 27, 2011
Start date September 2007
Est. completion date January 2008

Study information
Verified date January 2011
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 160
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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- All patients with mesh placed intra-abdominally during surgery have to be withdrawn

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• complete repair

• partial repair of the abdominal wall

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary recurrence rate 1 year
Secondary Perioperative morbidity rate
Secondary Postoperative pain
Secondary Long term complication rate
Secondary Recurrence rate 3 years
See also
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Completed NCT01961687 - A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair. N/A
Completed NCT02089958 - Standardization of Laparoscopic Hernia Repair N/A
Completed NCT00998907 - PDS*Plus and Wound Infections After Laparotomy N/A
Completed NCT04961346 - RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair N/A
Terminated NCT03912662 - ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention N/A
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Recruiting NCT03561727 - Risk Factors for Development of Incisional Hernia in Transverse Incisions N/A
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Not yet recruiting NCT05568238 - Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen N/A
Not yet recruiting NCT02896686 - Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure Phase 4
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Active, not recruiting NCT02328352 - "BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation" Phase 1/Phase 2
Suspended NCT01520168 - Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management N/A
Recruiting NCT05579652 - Change in Fascial Tension in Open Abdomens
Active, not recruiting NCT03390764 - Hernia After Colorectal Cancer Surgery N/A
Completed NCT02321059 - Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia N/A
Completed NCT02011048 - Giant Ventral Incisional Hernia: Abdominal Wall Function, Respiratory Performance and Quality of Life N/A

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