NCT06380621

Bilateral vs Unilateral Totally Extraperitoneal Repair Among Patients With Unilateral Inguinal Hernia

Completed NA Last updated 24 April 2024

What this trial tests

NA trial testing Totally Extra Peritoneal repair (TEP) repair in Inguinal Hernia in 60 participants. Completed in 15 March 2019.

Timeline

15 March 2018

Primary endpoint
15 February 2019

15 March 2019

Quick facts

Lead sponsor	B.P. Koirala Institute of Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	15 March 2018
Primary completion	15 February 2019
Estimated completion	15 March 2019
Sites	1 location across Nepal

Drugs / interventions tested

• Totally Extra Peritoneal repair (TEP) repair

Conditions studied

• Inguinal Hernia — all drugs for Inguinal Hernia →

Sponsor

B.P. Koirala Institute of Health Sciences

Who can join

Adults 16 to 55, any sex, with Inguinal Hernia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to investigate the feasibility of bilateral laparoscopic exploration for all unilateral cases followed by laparoscopic bilateral TEP repair in all cases with a contralateral occult hernia and to compare complications, recurrence rates, postoperative pain, and operative duration with prospectively performed unilateral repairs in young to middle-aged patients presenting with unilateral hernias in the surgery outpatient department.

The main questions it aims to answer are:

* To compare complications, recurrence rates, postoperative pain, and operative duration between both groups.
* Incidence of occult contralateral hernia Patients attending the OPD for unilateral inguinal hernia were counseled about the trial and fully encouraged to understand the difference between two procedures for unilateral hernia: bilateral exploration and bilateral TEP repair, upon which if a contralateral occult inguinal hernia was observed, documented, and controls were taken from the patients who denied bilateral exploration and underwent unilateral TEP repair. The allotment of patients was done in two groups of 30 patients each.

Researchers will compare Group A( bilateral TEP) with Group B (unilateral TEP) to see if complications, recurrence rates, postoperative pain, and operative duration occur in each group

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.