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. ]

The seroma formation is checked by clinical evaluation.


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