Laparoscopic Versus Open Mesh 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

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2020-06-30

Brief Summary

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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

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Detailed Description

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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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Conditions

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Bilateral Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Sealed opaque envelopes containing computer generated random numbers

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Laparoscopic Trans-Abdominal Pre-Peritoneal

Intervention Type PROCEDURE

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

Open Pre-Peritoneal Repair ( Open PP group)

Both hernias were treated by open pre-peritoneal single mesh repair with suture fixation

Group Type ACTIVE_COMPARATOR

Open pre-peritoneal repair

Intervention Type PROCEDURE

Open pre-peritoneal single mesh repair with suture fixation

Bilateral Lichtenstein repair (LICHT group)

treated by bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation

Group Type ACTIVE_COMPARATOR

Bilateral Lichtenstein repair

Intervention Type PROCEDURE

Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation

Interventions

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Laparoscopic Trans-Abdominal Pre-Peritoneal

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

Intervention Type PROCEDURE

Open pre-peritoneal repair

Open pre-peritoneal single mesh repair with suture fixation

Intervention Type PROCEDURE

Bilateral Lichtenstein repair

Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No