Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia

Not Applicable

Completed

• Conditions: Bilateral Inguinal Hernia; Postoperative Complications
• Interventions: Procedure: Bilateral TAPP Repair; Procedure: Open PP Repair; Procedure: Bilateral Lichtenstein Repair

• Registration Number: NCT04357665
• Lead Sponsor: University of Alexandria

Brief Summary

Currently, there is a controversy regarding the best approach for simultaneous repair of bilateral inguinal hernia. The aim of this study was to compare the outcome of laparoscopic versus open repair of bilateral inguinal hernia

Detailed Description

This prospective randomized study included 120 consecutive patients with bilateral primary inguinal hernia treated at Alexandria university hospital in the period between June 2014 and February 2017. Patients were randomized by sealed envelopes into 3 groups, each includes 40 patients. Group I treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes, Group II treated by open preperitoneal mesh repair, while Group III treated by bilateral Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative complications, pain, hospital stay, return to normal activity and work, chronic groin pain, patient's satisfaction and 3 years recurrence rate.

Statistical Analysis: Numerical data in both groups was expressed as mean

± standard deviation (SD) and compared using One-way analysis of variance while categorical data was expressed as percentages and compared using Chi-squared test. Logistic regression test was used to determine predictors of postoperative complications. Differences were considered significant at p \<0.05.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2017-01
• Study Completion: 2020-03
• Status Verified: 2020-04
• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-19
• Last Update Submitted: 2020-04-19
• Study First Posted: 2020-04-22
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with primary bilateral inguinal hernias in patients aged from 20 to 60 years

Exclusion Criteria

1. • Immune compromised patients,
2. • Morbid obesity (BMI > 35 kg/m2)
3. • Chronic liver or renal disease
4. • Coagulopathy
5. • High-risk patients unfit for major surgery (ASA III or IV)
6. • Recurrent hernias
7. • Complicated hernias
8. • Massive scrotal hernias
9. • Previous infra-umbilical surgery
10. Persistent groin pain due to other causes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lap TAPP Group	Bilateral TAPP Repair	Patients treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers
Open PP Group	Open PP Repair	Patients treated by open preperitoneal single mesh repair fixated using sutures
Bilateral LICHT Group	Bilateral Lichtenstein Repair	Patients treated by standard bilateral Lichtenstein repair using 2 separate meshes fixed by sutures

Primary Outcome Measures

Name	Time	Method
Operative time	Same day of surgery	Operative time (in minutes)
Early postoperative complications	30 days after the surgery	Any complications related to surgery developed within 30 days after the surgery
Postoperative pain 7 days after surgery	7 days after surgery	Pain intensity was assessed using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)

Secondary Outcome Measures

Name	Time	Method
Chronic postoperative pain	3 months after surgery	Groin pain related to surgery lasting for more than 3 months after surgery
Hernia recurrence	3 years after surgery	Unilateral or bilateral - residual or recurrent hernia within 3 years after surgery