Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia

• Sponsor: Alexandria University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04437784
• Collaborator: (none)
• Enrollment: 180
• Arms: 3
• Actual Duration (Months): 72

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bilateral Inguinal Hernia	Procedure: Laparoscopic Trans-Abdominal Pre-Peritoneal; Procedure: Open pre-peritoneal repair; Procedure: Bilateral Lichtenstein repair	N/A

Detailed 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.

.

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Sealed opaque envelopes containing computer generated random numbers
• Primary Purpose: Treatment
• Official Title: Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia; 3 Armed Randomized Study
• Actual Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group)) Both hernias were treated by laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers	Procedure: Laparoscopic Trans-Abdominal Pre-Peritoneal; Laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers
Active Comparator: Open Pre-Peritoneal Repair ( Open PP group) Both hernias were treated by open pre-peritoneal single mesh repair with suture fixation	Procedure: Open pre-peritoneal repair; Open pre-peritoneal single mesh repair with suture fixation
Active Comparator: Bilateral Lichtenstein repair (LICHT group) treated by bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation	Procedure: Bilateral Lichtenstein repair; Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation

Outcome Measures

Primary Outcome Measures

1. Operative time [From skin incision until incision closure at the end of surgery]

   Operative time (in minutes)

2. Postoperative pain after 24 hours [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 [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 [Within 30 days after the surgery]

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

Secondary Outcome Measures

1. Chronic Groin pain [After 3 months postoperatively]

   Groin pain lasting for more than 3 months after surgery

2. 3 years hernia recurrence rate [within 3 years after surgery]

   Unilateral or bilateral - residual or recurrent hernia

3. Patient's satisfaction score [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alexandria University

Investigators

• Principal Investigator: Mohamed Elmessiry, MD, PhD, Assistant Professor of Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

• Feliu X, Clavería R, Besora P, Camps J, Fernández-Sallent E, Viñas 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.
• 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.

• Responsible Party: Mohamed El Messiry, Assistant professor of Surgery, Alexandria University
• ClinicalTrials.gov Identifier: NCT04437784
• Other Study ID Numbers: 302765
• First Posted: Jun 18, 2020
• Last Update Posted: Jun 18, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hernia; Hernia, Inguinal

Study Results

No Results Posted as of Jun 18, 2020