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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920307
• Other study ID #: MK-002-LHR
• Status: Completed
• Phase: N/A
• First received: September 22, 2016
• Last updated: September 29, 2016
• Start date: May 2010
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Medical Park Gaziantep Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

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

Intervention

Procedure:
• TEP without fixation
Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair
• TEP with fixation
Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair
• TAPP without fixation
Standard transabdominal preperitoneal (TAPP) inguinal hernia repair without mesh fixation
• TAPP with fixation
Standard transabdominal preperitoneal (TAPP) inguinal hernia repair

Locations

Country	Name	City	State
Turkey	Medical Park Gaziantep Hospital	Gaziantep

Sponsors (3)

Lead Sponsor	Collaborator
Medical Park Gaziantep Hospital	Bahçesehir University, Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS)	neuralgia, inguinal	preoperative and postoperative 2nd year	No
Primary	Change from preoperative pain levels at 1 year assessed by the VAS	neuralgia, inguinal	preoperative and postoperative 1st year	No
Primary	Change from preoperative pain levels at 6 months assessed by the VAS	neuralgia, inguinal	preoperative and postoperative 6th month	No
Primary	Change from preoperative pain levels at 3 months assessed by the VAS	neuralgia, inguinal	preoperative and postoperative 3th month	No
Primary	Change from preoperative pain levels at 1 month assessed by the VAS	neuralgia, inguinal	preoperative and postoperative 1 month	No
Primary	Change from preoperative pain levels at 1 week assessed by the VAS	neuralgia, inguinal	preoperative and postoperative 1th week	No
Secondary	Total hospital costs	consisted all costs of hospital stays and outpatient treatments	up to 24 months	No
Secondary	conversion rate	conversion to open surgery	through the first day	No
Secondary	recurrence rate	clinical and radiological diagnosed	up to 24 months	No
Secondary	rate of minor and major complications	it was assessed as; no complication, minor complications, major complications and complications needed reoperation	2 year	No