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

Zealand University Hospital

Status: Completed

Conditions: Femoral Hernia; Inguinal Hernia

Treatments: Procedure: Tacks; Procedure: Fibrin glue

Study type: Interventional

Funder types: Other

Identifiers

NCT01000116

SJ-138

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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112 participants in 2 patient groups

Fibrin glue

Active Comparator group

Treatment:

Procedure: Tacks

Tacks

Active Comparator group

Treatment:

Procedure: Fibrin glue