Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia

University of Alexandria

Status: Completed

Conditions: Postoperative Complications; Bilateral Inguinal Hernia

Treatments: Procedure: Open PP Repair; Procedure: Bilateral TAPP Repair; Procedure: Bilateral Lichtenstein Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT04357665

0302765

Details and patient eligibility

About

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

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

Lap TAPP Group

Active Comparator group

Description:

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

Treatment:

Procedure: Bilateral TAPP Repair

Open PP Group

Active Comparator group

Description:

Patients treated by open preperitoneal single mesh repair fixated using sutures

Treatment:

Procedure: Open PP Repair

Bilateral LICHT Group

Active Comparator group

Description:

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

Treatment:

Procedure: Bilateral Lichtenstein Repair