Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2020-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Bilateral Inguinal Hernia Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Lap TAPP Group

Patients treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers

Group Type ACTIVE_COMPARATOR

Bilateral TAPP Repair

Intervention Type PROCEDURE

laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers

Open PP Group

Patients treated by open preperitoneal single mesh repair fixated using sutures

Group Type ACTIVE_COMPARATOR

Open PP Repair

Intervention Type PROCEDURE

Open pre-peritoneal repair using single mesh fixed by sutures

Bilateral LICHT Group

Patients treated by standard bilateral Lichtenstein repair using 2 separate meshes fixed by sutures

Group Type ACTIVE_COMPARATOR

Bilateral Lichtenstein Repair

Intervention Type PROCEDURE

Bilateral Lichtenstein Repair using 2 separate meshes fixed by sutures

Interventions

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Bilateral TAPP Repair

laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers

Intervention Type PROCEDURE

Open PP Repair

Open pre-peritoneal repair using single mesh fixed by sutures

Intervention Type PROCEDURE

Bilateral Lichtenstein Repair

Bilateral Lichtenstein Repair using 2 separate meshes fixed by sutures

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No