Study of Laparoscopic Inguinal Hernia Repair

Not Applicable

Completed

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

• Registration Number: NCT02920307
• Lead Sponsor: Medical Park Gaziantep Hospital

Brief 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.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2014-09
• Status Verified: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-09-29
• Last Update Submitted: 2016-09-29
• Study First Posted: 2016-09-30
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• unilateral hernia
• uncomplicated hernia
• medical fitness for general anesthesia

Exclusion Criteria

• unfit for general anesthesia
• complicated hernia
• uncorrectable coagulopathy
• BMI > 35
• concomitant pathologies requiring simultaneous surgery
• bilateral hernia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS)	preoperative and postoperative 2nd year	neuralgia, inguinal
Change from preoperative pain levels at 1 year assessed by the VAS	preoperative and postoperative 1st year	neuralgia, inguinal
Change from preoperative pain levels at 6 months assessed by the VAS	preoperative and postoperative 6th month	neuralgia, inguinal
Change from preoperative pain levels at 3 months assessed by the VAS	preoperative and postoperative 3th month	neuralgia, inguinal
Change from preoperative pain levels at 1 month assessed by the VAS	preoperative and postoperative 1 month	neuralgia, inguinal
Change from preoperative pain levels at 1 week assessed by the VAS	preoperative and postoperative 1th week	neuralgia, inguinal

Secondary Outcome Measures

Name	Time	Method
Total hospital costs	up to 24 months	consisted all costs of hospital stays and outpatient treatments
conversion rate	through the first day	conversion to open surgery
recurrence rate	up to 24 months	clinical and radiological diagnosed
rate of minor and major complications	2 year	it was assessed as; no complication, minor complications, major complications and complications needed reoperation

Trial Locations

Locations (1)

Medical Park Gaziantep Hospital; 🇹🇷 Gaziantep, Turkey