NCT04357665

Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia

Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia 3 Armed Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Alexandria · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bilateral Inguinal Hernia
• Postoperative Complications

Interventions

Type	Name	Description
PROCEDURE	Bilateral TAPP Repair	laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers
PROCEDURE	Open PP Repair	Open pre-peritoneal repair using single mesh fixed by sutures
PROCEDURE	Bilateral Lichtenstein Repair	Bilateral Lichtenstein Repair using 2 separate meshes fixed by sutures

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-01-01
• Completion: 2020-03-01
• First posted: 2020-04-22
• Last updated: 2020-04-22