Clinical trial NCT02920307: Study of Laparoscopic Inguinal Hernia Repair
Official title: Prospective, Randomized and Controlled Study Comparing Fixation Versus no Fixation of Mesh in Laparoscopic Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Inguinal Hernia, Direct
Inguinal Hernia, Indirect
Hernia, Femoral
Recurrence
Neuralgia, Atypical
Neuralgia, Ilioinguinal
Neuralgia, Iliohypogastric Nerve
Keywords: laparoscopic inguinal hernia repair
total extraperitoneoscopic hernia repair
transabdominal preperitoneal hernia repair
inguinal hernia
laparoscopy
hernia repair
herniorraphy
laparoscopic surgery
Lead sponsor: Medical Park Gaziantep Hospital
Sponsor class: OTHER
Collaborators: name: Muğla Sıtkı Koçman University
name: Bahçeşehir University
First posted: 2016-09-30
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS)
timeFrame: preoperative and postoperative 2nd year
measure: Change from preoperative pain levels at 1 year assessed by the VAS
timeFrame: preoperative and postoperative 1st year
measure: Change from preoperative pain levels at 6 months assessed by the VAS
timeFrame: preoperative and postoperative 6th month
measure: Change from preoperative pain levels at 3 months assessed by the VAS
timeFrame: preoperative and postoperative 3th month
measure: Change from preoperative pain levels at 1 month assessed by the VAS
timeFrame: preoperative and postoperative 1 month
measure: Change from preoperative pain levels at 1 week assessed by the VAS
timeFrame: preoperative and postoperative 1th week
Secondary outcomes:
measure: Total hospital costs
timeFrame: up to 24 months
measure: conversion rate
timeFrame: through the first day
measure: recurrence rate
timeFrame: up to 24 months
measure: rate of minor and major complications
timeFrame: 2 year
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Medical Park Gaziantep Hospital
Study officials:
affiliation: Bahçeşehir Üniversitesi Tıp Fakültesi
name: Mehmet Kaplan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mugla University, School of Medicine
name: Onder Ozcan, M.D.
role: STUDY_CHAIR
References: