Clinical Trial: Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Fibrin Glue Versus Tacked Fixation in Laparoscopic Groin Hernia Repair. A Randomized Double-blind Placebo-controlled Trial.

Brief Summary: In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Moreover, the researchers investigate general well-being, fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are investigating chronic pain and clinical recurrence.

Detailed Summary:
Sponsor: University Hospital Koge

Current Primary Outcome: Early pain after operation [ Time Frame: 1 month ]

Original Primary Outcome: Early pain after operation [ Time Frame: day 0-3, day 10, day 30 ]

Current Secondary Outcome:

  • haematoma in groin region [ Time Frame: day 10 ]
  • seroma in groin region [ Time Frame: day 10 ]
  • fatigue [ Time Frame: 10 days ]
  • discomfort [ Time Frame: 6 month ]
  • Postoperative nausea and vomiting (PONV) [ Time Frame: 10 days ]
  • Use of Analgesics at PACU [ Time Frame: 1 day ]


Original Secondary Outcome:

  • haematoma in groin region [ Time Frame: day 10 ]
  • seroma in groin region [ Time Frame: day 10 ]
  • fatigue [ Time Frame: day 0-3, day 10 ]
  • general well-being [ Time Frame: day 0-3, day 10, 1 + 6 month ]
  • Postoperative nausea and vomiting (PONV) [ Time Frame: day 0-3, day 10 ]


Information By: University Hospital Koge

Dates:
Date Received: October 16, 2009
Date Started: September 2009
Date Completion:
Last Updated: April 12, 2012
Last Verified: April 2012