Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Bilateral Inguinal Hernia
• Intervention / Treatment: Procedure: Bilateral TAPP Repair; Procedure: Open PP Repair; Procedure: Bilateral Lichtenstein Repair

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Lap TAPP Group; Patients treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers	Procedure: Bilateral TAPP Repair; laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers
ACTIVE_COMPARATOR: Open PP Group; Patients treated by open preperitoneal single mesh repair fixated using sutures	Procedure: Open PP Repair; Open pre-peritoneal repair using single mesh fixed by sutures
ACTIVE_COMPARATOR: Bilateral LICHT Group; Patients treated by standard bilateral Lichtenstein repair using 2 separate meshes fixed by sutures	Procedure: Bilateral Lichtenstein Repair; Bilateral Lichtenstein Repair using 2 separate meshes fixed by sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Operative time (in minutes)	Same day of surgery
Postoperative pain 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)	7 days after surgery
Early postoperative complications	Any complications related to surgery developed within 30 days after the surgery	30 days after the surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alexandria
• Investigators: Principal Investigator: Mohamed Elmessiry, Ass. Professor of Surgery; Principal Investigator: Ahmed Gebaly, Ass. Professor of Surgery

Publications and helpful links

General Publications

• Feliu X, Claveria R, Besora P, Camps J, Fernandez-Sallent E, Vinas X, Abad JM. Bilateral inguinal hernia repair: laparoscopic or open approach? Hernia. 2011 Feb;15(1):15-8. doi: 10.1007/s10029-010-0736-2. Epub 2010 Oct 21.
• Sarli L, Iusco DR, Sansebastiano G, Costi R. Simultaneous repair of bilateral inguinal hernias: a prospective, randomized study of open, tension-free versus laparoscopic approach. Surg Laparosc Endosc Percutan Tech. 2001 Aug;11(4):262-7. doi: 10.1097/00129689-200108000-00007.
• Mahon D, Decadt B, Rhodes M. Prospective randomized trial of laparoscopic (transabdominal preperitoneal) vs open (mesh) repair for bilateral and recurrent inguinal hernia. Surg Endosc. 2003 Sep;17(9):1386-90. doi: 10.1007/s00464-002-9223-x. Epub 2003 Jun 17.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2014
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 19, 2020
• First Posted (ACTUAL): April 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 19, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Recurrence; Bilateral Inguinal Hernia; Laparoscopic versus open mesh repair; Operative outcomes
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Postoperative Complications
• Other Study ID Numbers: 0302765

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No consent to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No