Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia

Alexandria University180 enrolled

Overview

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

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. .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Bilateral Inguinal Hernia

Interventions

Laparoscopic Trans-Abdominal Pre-PeritonealPROCEDURE

Laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers

Open pre-peritoneal repairPROCEDURE

Open pre-peritoneal single mesh repair with suture fixation

Bilateral Lichtenstein repairPROCEDURE

Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Operative time

Operative time (in minutes)

Time frame: 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)

Time frame: 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)

Time frame: 7 days after surgery

Early postoperative complications

All complication related to surgery developed within 30 days after the surgery

Time frame: Within 30 days after the surgery

Secondary Outcomes

Chronic Groin pain

Groin pain lasting for more than 3 months after surgery

Time frame: After 3 months postoperatively

3 years hernia recurrence rate

Unilateral or bilateral - residual or recurrent hernia

Time frame: 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

Time frame: within 3 years after surgery

Data from ClinicalTrials.gov

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