Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia

• Sponsor: University of Alexandria (Other)
• Overall Status: Completed
• CT.gov ID: NCT04357665
• Collaborator: (none)
• Enrollment: 120
• Arms: 3
• Actual Duration (Months): 69

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Bilateral Inguinal Hernia; Postoperative Complications	Procedure: Bilateral TAPP Repair; Procedure: Open PP Repair; Procedure: Bilateral Lichtenstein Repair	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This prospective study included 120 consecutive patients with bilateral primary inguinal hernia managed by simultaneous bilateral repair. Patients were randomized by sealed opaque envelopes containing computer generated random numbers into 3 groups, each includes 40 patients. Group I treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes (Lap TAPP), Group II treated by open preperitoneal mesh repair with mesh fixation (Open PP), while Group III treated by standard bilateral Lichtenstein repair (LICHT group).This prospective study included 120 consecutive patients with bilateral primary inguinal hernia managed by simultaneous bilateral repair. Patients were randomized by sealed opaque envelopes containing computer generated random numbers into 3 groups, each includes 40 patients. Group I treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes (Lap TAPP), Group II treated by open preperitoneal mesh repair with mesh fixation (Open PP), while Group III treated by standard bilateral Lichtenstein repair (LICHT group).
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia 3 Armed Randomized Trial
• Actual Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Operative time [Same day of surgery]

   Operative time (in minutes)

2. 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)

3. Early postoperative complications [30 days after the surgery]

   Any complications related to surgery developed within 30 days after the surgery

Secondary Outcome Measures

1. Chronic postoperative pain [3 months after surgery]

   Groin pain related to surgery lasting for more than 3 months after surgery

2. Hernia recurrence [3 years after surgery]

   Unilateral or bilateral - residual or recurrent hernia within 3 years after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Alexandria

Investigators

• Principal Investigator: Mohamed Elmessiry, Ass. Professor of Surgery
• Principal Investigator: Ahmed Gebaly, Ass. Professor of Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

• Feliu X, Clavería R, Besora P, Camps J, Fernández-Sallent E, Viñas 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.
• 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. Epub 2003 Jun 17.
• 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.

• Responsible Party: Mohamed El Messiry, Ass. Professor of Surgery, University of Alexandria
• ClinicalTrials.gov Identifier: NCT04357665
• Other Study ID Numbers: 0302765
• First Posted: Apr 22, 2020
• Last Update Posted: Apr 22, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohamed El Messiry, Ass. Professor of Surgery, University of Alexandria: Bilateral Inguinal Hernia; Laparoscopic versus open mesh repair; Operative outcomes; Recurrence
• Additional relevant MeSH terms: Hernia; Postoperative Complications; Hernia, Inguinal

Study Results

No Results Posted as of Apr 22, 2020