Clinical Trial: The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair.
Brief Summary: A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in laparoscopic ventral hernia repair.
Detailed Summary:
Sponsor: University Hospital, Ghent
Current Primary Outcome: Seroma formation after 4 weeks. [ Time Frame: 4 weeks after surgery. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pain, discomfort and esthetic evaluation after 4 weeks. [ Time Frame: 4 weeks after surgery. ]Pain, discomfort and esthetic evaluation is performed after 4 weeks by clinical evaluation and the Visual Analogue Scale.
- Pain, discomfort and esthetic evaluation after 1 year. [ Time Frame: 1 year after surgery. ]Pain, discomfort and esthetic evaluation is performed after 1 year by clinical evaluation and the Visual Analogue Scale.
- Pain, discomfort and esthetic evaluation after 2 years. [ Time Frame: 2 years after surgery. ]Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale.
Original Secondary Outcome: Same as current
Information By: University Hospital, Ghent
Dates:
Date Received: October 30, 2012
Date Started: October 2012
Date Completion: December 2015
Last Updated: December 4, 2014
Last Verified: December 2014