Study of Laparoscopic Inguinal Hernia Repair

Recurrence Clinical Trial

Official title: Prospective, Randomized and Controlled Study Comparing Fixation Versus no Fixation of Mesh in Laparoscopic Inguinal Hernia Repair

Status Completed

Clinical Trial Summary

Although mesh fixation has been associated to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.

Clinical Trial Description

A randomized prospective study was conducted. Four groups of patients were constituted: (1) TEP with mesh fixation (2) TEP without fixation, (3) TAPP with mesh fixation, (4) TAPP without fixation. 120 patients were randomized to each group. The principal outcomes assessed were postoperative chronic groin pain assessed by visual analogue pain scale (VAS), hernia recurrence, other morbidity rates and hospital costs. Patients were reviewed in outpatient unit at 1 week and at 1, 6, 12 and 24 months. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Femoral
• Hernia, Inguinal
• Inguinal Hernia, Direct
• Inguinal Hernia, Indirect
• Neuralgia
• Neuralgia, Atypical
• Neuralgia, Iliohypogastric Nerve
• Neuralgia, Ilioinguinal
• Recurrence

• NCT number: NCT02920307
• Study type: Interventional
• Source: Medical Park Gaziantep Hospital
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Completion date: September 2016