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NCT00573105 Clinical Trial

Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)

Ventral Hernia Clinical Trial

Official title:
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00573105
Other study ID # 2007/421
Secondary ID
Status Terminated
Phase N/A
First received December 11, 2007
Last updated January 25, 2011
Start date February 2008
Est. completion date November 2010

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

1. General

- antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery

2. Laparoscopic surgery

- at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)

- with or without anchoring transparietal sutures or double crown technique

Recruitment information / eligibility
Status Terminated
Enrollment 110
Est. completion date November 2010
Est. primary completion date November 2010
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

- ventral hernia requiring elective surgical repair

Exclusion Criteria:

- no written informed consent

- 'hostile' abdomen; open abdomen treatment

- contraindication to pneumoperitoneum

- emergency surgery (incarcerated hernia)

- parastomal hernia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic Ventral hernia repair by heavy weight mesh
Laparoscopic Ventral hernia repair by heavy weight mesh
• Laparoscopic Ventral hernia repair by lighter weight mesh
Laparoscopic Ventral hernia repair by lighter weight mesh

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent C. R. Bard

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary recurrence rate after 1 year No
Secondary morbidity rate perioperative Yes
Secondary quality of life after 1 year No
Secondary postoperative pain within 1 week No
Secondary long term complication rate after 1 year No
See also
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Completed NCT01325246 - Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair N/A
Completed NCT03283982 - Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM N/A
Not yet recruiting NCT05526209 - Longitudinal Relaxing Incision as a Technique for Recurrence Prevention in Ventral Hernia
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Recruiting NCT04173884 - Video-based Collaborative Learning to Improve Ventral Hernia Repair N/A
Recruiting NCT02703662 - Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction Phase 2/Phase 3
Completed NCT03938688 - Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation N/A
Completed NCT01719718 - The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair N/A
Completed NCT03342040 - Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair N/A
Completed NCT04150796 - Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral Hernias N/A
Recruiting NCT03222102 - Ventral Hernia Prevention After Liver Transplantation N/A
Completed NCT05610267 - Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Terminated NCT01794338 - The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients N/A
Completed NCT01886963 - A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair N/A

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