Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia

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

The best approach for simultaneous repair of bilateral inguinal hernia is controversial. The aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of bilateral primary inguinal hernia

Study Overview

• Status: Completed
• Conditions: Bilateral Inguinal Hernia
• Intervention / Treatment: Procedure: Laparoscopic Trans-Abdominal Pre-Peritoneal; Procedure: Open pre-peritoneal repair; Procedure: Bilateral Lichtenstein repair

Detailed Description

This prospective study included 180 patients with bilateral primary inguinal hernia; randomized by sealed envelopes into 3 groups; each includes 60 patients. Group I treated by laparoscopic trans-abdominal pre-peritoneal (TAPP) repair using 2 separate meshes, Group II treated by open pre-peritoneal (PP) single mesh repair, while Group III treated by bilateral Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative complications, postoperative pain, 3 years-recurrence rate and patient's satisfaction.

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• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with painless uncomplicated primary bilateral inguinal hernias

Exclusion Criteria:

• Immune compromised patients
• Coagulopathy
• Chronic liver or renal disease
• High-risk patients unfit for major surgery (ASA III or IV),
• Massive scrotal hernias, Recurrent or Complicated hernias
• Groin pain due to any other pathology
• Previous infra-umbilical surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group)); Both hernias were treated by laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers	Procedure: Laparoscopic Trans-Abdominal Pre-Peritoneal; Laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers
Active Comparator: Open Pre-Peritoneal Repair ( Open PP group); Both hernias were treated by open pre-peritoneal single mesh repair with suture fixation	Procedure: Open pre-peritoneal repair; Open pre-peritoneal single mesh repair with suture fixation
Active Comparator: Bilateral Lichtenstein repair (LICHT group); treated by bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation	Procedure: Bilateral Lichtenstein repair; Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Operative time (in minutes)	From skin incision until incision closure at the end of surgery
Postoperative pain after 24 hours	Pain intensity was assessed 24 hours after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)	24 hours after surgery
Postoperative pain after 7 days	Pain intensity was assessed 7 days after surgery 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	All complication related to surgery developed within 30 days after the surgery	Within 30 days after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic Groin pain	Groin pain lasting for more than 3 months after surgery	After 3 months postoperatively
3 years hernia recurrence rate	Unilateral or bilateral - residual or recurrent hernia	within 3 years after surgery
Patient's satisfaction score	Patient satisfaction was assessed using 1 to 10 scale where: 9-10 means very satisfied, 7-8: satisfied, 6-7: neutral, 4-5: dissatisfied, <4: very dissatisfied	within 3 years after surgery

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Mohamed Elmessiry, MD, PhD, Assistant professor of surgery

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 302765

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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