Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia

Not Applicable

Completed

• Conditions: Bilateral Inguinal Hernia
• Interventions: Procedure: Open pre-peritoneal repair; Procedure: Laparoscopic Trans-Abdominal Pre-Peritoneal; Procedure: Bilateral Lichtenstein repair

• Registration Number: NCT04437784
• Lead Sponsor: Alexandria University

Brief Summary

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

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 Timeline

• Study Start: 2014-06
• Primary Completion: 2017-06
• Status Verified: 2020-06
• Study Completion: 2020-06
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-17
• Last Update Submitted: 2020-06-17
• Study First Posted: 2020-06-18
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Operative time	From skin incision until incision closure at the end of surgery	Operative time (in minutes)
Postoperative pain after 7 days	7 days after surgery	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)
Early postoperative complications	Within 30 days after the surgery	All complication related to surgery developed within 30 days after the surgery
Postoperative pain after 24 hours	24 hours after surgery	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)

Secondary Outcome Measures

Name	Time	Method
3 years hernia recurrence rate	within 3 years after surgery	Unilateral or bilateral - residual or recurrent hernia
Patient's satisfaction score	within 3 years after surgery	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
Chronic Groin pain	After 3 months postoperatively	Groin pain lasting for more than 3 months after surgery