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Completed

NCT Number: NCT04357665

Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia

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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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with primary bilateral inguinal hernias in patients aged from 20 to 60 years

Exclusion criteria

  • - Immune compromised patients,
  • - Morbid obesity (BMI > 35 kg/m2)
  • - Chronic liver or renal disease
  • - Coagulopathy
  • - High-risk patients unfit for major surgery (ASA III or IV)
  • - Recurrent hernias
  • - Complicated hernias
  • - Massive scrotal hernias
  • - Previous infra-umbilical surgery
  • Persistent groin pain due to other causes

Treatment and study plan

Bilateral TAPP Repair

Procedure

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

Open PP Repair

Procedure

Open pre-peritoneal repair using single mesh fixed by sutures

Bilateral Lichtenstein Repair

Procedure

Bilateral Lichtenstein Repair using 2 separate meshes fixed by sutures

Primary outcomes

  1. Operative time

    Time frame: Same day of surgery

    Operative time (in minutes)

  2. Postoperative pain 7 days after surgery

    Time frame: 7 days after surgery

    Pain intensity was assessed using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)

  3. Early postoperative complications

    Time frame: 30 days after the surgery

    Any complications related to surgery developed within 30 days after the surgery

Secondary outcomes

  1. Chronic postoperative pain

    Time frame: 3 months after surgery

    Groin pain related to surgery lasting for more than 3 months after surgery

  2. Hernia recurrence

    Time frame: 3 years after surgery

    Unilateral or bilateral - residual or recurrent hernia within 3 years after surgery

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia 3 Armed Randomized Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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