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

Not Applicable

Completed

• Conditions: Inguinal Hernia; Femoral Hernia
• Interventions: Procedure: Tacks; Procedure: Fibrin glue

• Registration Number: NCT01000116
• Lead Sponsor: Zealand University Hospital

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 Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2009-10-21
• Study First Posted: 2009-10-22
• Primary Completion: 2011-08
• Study Completion: 2012-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 112

Inclusion Criteria

• unilateral groin hernia
• planned laparoscopic inguinal or femoral herniorrhaphy
• ASA I-III
• fluent Danish

Exclusion Criteria

• converting to open operation
• low compliance
• daily use of morphine or similar drugs daily in the last month
• complications to the operation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibrin glue	Tacks	-
Tacks	Fibrin glue	-

Primary Outcome Measures

Name	Time	Method
Early pain after operation	1 month

Secondary Outcome Measures

Name	Time	Method
seroma in groin region	day 10
haematoma in groin region	day 10
fatigue	10 days
discomfort	6 month
Use of Analgesics at PACU	1 day
Postoperative nausea and vomiting (PONV)	10 days

Trial Locations

Locations (1)

Private Hospital Hamlet; 🇩🇰 Søborg, Denmark