Mesh Fixation With Intraperitoneal Tisseel

Herlev Hospital40 enrolled

Overview

The purpose of this study is to determine whether mesh fixation in laparoscopic umbilical hernia repair with fibrin glue is superior to tacks in terms of postoperative pain and recovery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postoperative Pain Ventral Hernia

Interventions

tack fixation of meshPROCEDURE

tack fixation of mesh

glue fixation of meshPROCEDURE

glue fixation of mesh

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: 18-85 years and Danish speaking * Umbilical hernia Ø 1.5 - 5 cm at preoperative clinical examination * ASA group I-III Exclusion Criteria: * Former laparoscopic umbilical herniotomy * Incarceration * Drug/alcohol abuse/ongoing use of strong analgesic * Bad compliance * Liver disease Child-Pugh stage B/C * Immunodeficiency (ex. steroid use) * Pregnancy * Other hernias recognized perop. and operated on at the same operation * Lack of consent

Locations (4)

Bispebjerg University Hospital, Dept. Surgical Gastroenterology

Copenhagen, Denmark

Gentofte University Hospital, Dept. Surg. Gastroenterology

Gentofte, Copenhagen, Denmark

Herlev University Hospital, Dept. Surgical Gastroenterology

Herlev, Denmark

Køge University Hospital, Dept. Surg. Gastroenterology

Koege, Denmark

Outcomes

Primary Outcomes

Postoperative pain VAS 0-100 mm

Time frame: 1 year

Secondary Outcomes

QoL, SF-36, recurrence (safety)

Time frame: 1 year

Data from ClinicalTrials.gov

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