Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia

NCT04357665 | Completed DMC

• 1 other identifier: 0302765
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Bilateral Inguinal Hernia; Postoperative Complications

Keywords

Bilateral Inguinal Hernia; Laparoscopic versus open mesh repair; Operative outcomes; Recurrence

Outcome Measures

Primary Outcomes (3)

• Operative time

  Operative time (in minutes)

  Same day of surgery

• Postoperative pain 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)

  7 days after surgery

• Early postoperative complications

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

  30 days after the surgery

Secondary Outcomes (2)

• Chronic postoperative pain

  3 months after surgery

• Hernia recurrence

  3 years after surgery

Study Arms (3)

Lap TAPP Group

ACTIVE COMPARATOR

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

Procedure: Bilateral TAPP Repair

Open PP Group

ACTIVE COMPARATOR

Patients treated by open preperitoneal single mesh repair fixated using sutures

Procedure: Open PP Repair

Bilateral LICHT Group

ACTIVE COMPARATOR

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

Procedure: Bilateral Lichtenstein Repair

Interventions

Bilateral TAPP Repair PROCEDURE

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

Lap TAPP Group

Open PP Repair PROCEDURE

Open pre-peritoneal repair using single mesh fixed by sutures

Open PP Group

Bilateral Lichtenstein Repair PROCEDURE

Bilateral Lichtenstein Repair using 2 separate meshes fixed by sutures

Bilateral LICHT Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Alexandria: lead

Related Publications (3)

• Feliu X, Claveria R, Besora P, Camps J, Fernandez-Sallent E, Vinas X, Abad JM. Bilateral inguinal hernia repair: laparoscopic or open approach? Hernia. 2011 Feb;15(1):15-8. doi: 10.1007/s10029-010-0736-2. Epub 2010 Oct 21.

  PMID: 20960019 BACKGROUND

• Sarli L, Iusco DR, Sansebastiano G, Costi R. Simultaneous repair of bilateral inguinal hernias: a prospective, randomized study of open, tension-free versus laparoscopic approach. Surg Laparosc Endosc Percutan Tech. 2001 Aug;11(4):262-7. doi: 10.1097/00129689-200108000-00007.

  PMID: 11525372 BACKGROUND

• Mahon D, Decadt B, Rhodes M. Prospective randomized trial of laparoscopic (transabdominal preperitoneal) vs open (mesh) repair for bilateral and recurrent inguinal hernia. Surg Endosc. 2003 Sep;17(9):1386-90. doi: 10.1007/s00464-002-9223-x. Epub 2003 Jun 17.

  PMID: 12802653 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Recurrence

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Mohamed Elmessiry

  Ass. Professor of Surgery

  PRINCIPAL INVESTIGATOR

• Ahmed Gebaly

  Ass. Professor of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Professor of Surgery

Model Details: This prospective study included 120 consecutive patients with bilateral primary inguinal hernia managed by simultaneous bilateral repair. Patients were randomized by sealed opaque envelopes containing computer generated random numbers into 3 groups, each includes 40 patients. Group I treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes (Lap TAPP), Group II treated by open preperitoneal mesh repair with mesh fixation (Open PP), while Group III treated by standard bilateral Lichtenstein repair (LICHT group).

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 22, 2020
• Study Start: June 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share