Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia

Alexandria University

Status: Completed

Conditions: Bilateral Inguinal Hernia

Treatments: Procedure: Open pre-peritoneal repair; Procedure: Laparoscopic Trans-Abdominal Pre-Peritoneal; Procedure: Bilateral Lichtenstein repair

Study type: Interventional

Funder types: Other

Identifiers

NCT04437784

302765

Details and patient eligibility

About

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

Full 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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Enrollment: 180 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups

Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group))

Active Comparator group

Description:

Both hernias were treated by laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers

Treatment:

Procedure: Laparoscopic Trans-Abdominal Pre-Peritoneal

Open Pre-Peritoneal Repair ( Open PP group)

Active Comparator group

Description:

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

Treatment:

Procedure: Open pre-peritoneal repair

Bilateral Lichtenstein repair (LICHT group)

Active Comparator group

Description:

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

Treatment:

Procedure: Bilateral Lichtenstein repair