Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia
This trial is active, not recruiting.
|Conditions||ventral hernia, postoperative pain|
|Treatments||ventral hernia repair using full thickness skin graft, ventral hernia repair using mesh|
|Start date||December 2009|
|End date||December 2016|
|Trial size||50 participants|
|Trial identifier||NCT01413412, 2009/227-31/3|
This is a prospective randomized study to compare surgical methods for the repair of large abdominal hernia.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Rate of complication
time frame: 3 month, 1 year and 3 year post-operative clinical follow-up
Ventral Hernia Pain Questionnaire (VHPQ)
time frame: 1 year period of follow-up
Abdominal wall function
time frame: 3 year period of follow up
Male or female participants from 18 years up to 90 years old.
Inclusion Criteria: - ventral hernia > 10 centimeters, abdominal wall pain or discomfort, desire hernia repair. Exclusion Criteria: - < 18 years of age, ongoing pregnancy or nursing, ongoing immunosuppressive treatment,ongoing smoking.
|Official title||Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia - a Prospective Randomized Controlled Study|
|Principal investigator||Leonard Clay, MD|
|Description||Patients with giant (>10 cm in diameter) abdominal wall hernia are included in a prospective randomized study comparing conventional mesh repair with the best possible method to onlay full thickness skin grafts.|
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