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

Zealand University Hospital112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

112

Conditions

Inguinal Hernia Femoral Hernia

Interventions

Fibrin gluePROCEDURE

Tissucol 2 ml

TacksPROCEDURE

Protacks

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Private Hospital Hamlet

Søborg, Denmark

Outcomes

Primary Outcomes

Early pain after operation

Time frame: 1 month

Secondary Outcomes

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

Data from ClinicalTrials.gov

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