NCT02920307

Study of Laparoscopic Inguinal Hernia Repair

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Medical Park Gaziantep Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	TEP without fixation	Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair
PROCEDURE	TEP with fixation	Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair
PROCEDURE	TAPP without fixation	Standard transabdominal preperitoneal (TAPP) inguinal hernia repair without mesh fixation
PROCEDURE	TAPP with fixation	Standard transabdominal preperitoneal (TAPP) inguinal hernia repair

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-09-01
• Completion: 2016-09-01
• First posted: 2016-09-30
• Last updated: 2016-09-30

Locations

1 site across 1 country: Turkey (Türkiye)