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NCT Number: NCT04437784

Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia

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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Key information

Conditions

Bilateral Inguinal Hernia

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Laparoscopic Trans-Abdominal Pre-Peritoneal

Procedure

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

Open pre-peritoneal repair

Procedure

Open pre-peritoneal single mesh repair with suture fixation

Bilateral Lichtenstein Repair

Procedure

Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation

Primary outcomes

  1. Operative time

    Time frame: From skin incision until incision closure at the end of surgery

    Operative time (in minutes)

  2. Postoperative pain after 24 hours

    Time frame: 24 hours after surgery

    Pain intensity was assessed 24 hours after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)

  3. Postoperative pain after 7 days

    Time frame: 7 days after surgery

    Pain intensity was assessed 7 days after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)

  4. Early postoperative complications

    Time frame: Within 30 days after the surgery

    All complication related to surgery developed within 30 days after the surgery

Secondary outcomes

  1. Chronic Groin pain

    Time frame: After 3 months postoperatively

    Groin pain lasting for more than 3 months after surgery

  2. 3 years hernia recurrence rate

    Time frame: within 3 years after surgery

    Unilateral or bilateral - residual or recurrent hernia

  3. Patient's satisfaction score

    Time frame: within 3 years after surgery

    Patient satisfaction was assessed using 1 to 10 scale where: 9-10 means very satisfied, 7-8: satisfied, 6-7: neutral, 4-5: dissatisfied, <4: very dissatisfied

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2020
First posted
Jun 18, 2020
Registry last updated
Jun 18, 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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