Study of Laparoscopic Inguinal Hernia Repair

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrence; Hernia, Inguinal; Hernia, Femoral; Inguinal Hernia, Indirect; Inguinal Hernia, Direct; Neuralgia, Atypical; Neuralgia, Ilioinguinal; Neuralgia, Iliohypogastric Nerve
• Intervention / Treatment: Procedure: TEP without fixation; Procedure: TEP with fixation; Procedure: TAPP without fixation; Procedure: TAPP with fixation

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gaziantep, Turkey, 27090
    • Medical Park Gaziantep Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEP without fixation; Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair without mesh fixation	Procedure: TEP without fixation; Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair; Other Names: TEP no fixation
Active Comparator: TEP with fixation; Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair	Procedure: TEP with fixation; Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair; Other Names: Standard TEP
Experimental: TAPP without fixation; Standard transabdominal preperitoneal (TAPP) hernia repair without mesh fixation	Procedure: TAPP without fixation; Standard transabdominal preperitoneal (TAPP) inguinal hernia repair without mesh fixation; Other Names: TAPP no fixation
Active Comparator: TAPP with fixation; Standard transabdominal preperitoneal (TAPP) hernia repair	Procedure: TAPP with fixation; Standard transabdominal preperitoneal (TAPP) inguinal hernia repair; Other Names: Standard TAPP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical Park Gaziantep Hospital
• Collaborators: Muğla Sıtkı Koçman University; Bahçeşehir University
• Investigators: Principal Investigator: Mehmet Kaplan, M.D., Bahçeşehir Üniversitesi Tıp Fakültesi; Study Chair: Onder Ozcan, M.D., Mugla University, School of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 22, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: laparoscopy; laparoscopic surgery; inguinal hernia; hernia repair; laparoscopic inguinal hernia repair; total extraperitoneoscopic hernia repair; transabdominal preperitoneal hernia repair; herniorraphy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease Attributes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Neuralgia; Recurrence; Hernia, Femoral
• Other Study ID Numbers: MK-002-LHR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES