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Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia

Primary Purpose

Bilateral Inguinal Hernia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Laparoscopic Trans-Abdominal Pre-Peritoneal

Open pre-peritoneal repair

Bilateral Lichtenstein repair

About this trial

This is an interventional treatment trial for Bilateral Inguinal Hernia

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group))

Open Pre-Peritoneal Repair ( Open PP group)

Bilateral Lichtenstein repair (LICHT group)

Arm Description

Both hernias were treated by laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers

Both hernias were treated by open pre-peritoneal single mesh repair with suture fixation

treated by bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation

Outcomes

Primary Outcome Measures

Operative time

Operative time (in minutes)

Postoperative pain after 24 hours

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)

Postoperative pain after 7 days

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)

Early postoperative complications

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

Secondary Outcome Measures

Chronic Groin pain

Groin pain lasting for more than 3 months after surgery

3 years hernia recurrence rate

Unilateral or bilateral - residual or recurrent hernia

Patient's satisfaction score

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

Full Information

NCT ID

NCT04437784

First Posted

June 16, 2020

Last Updated

June 17, 2020

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04437784

Brief Title

Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

June 2014 (Actual)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bilateral Inguinal Hernia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Sealed opaque envelopes containing computer generated random numbers

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group))

Arm Type

Active Comparator

Arm Description

Both hernias were treated by laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers

Arm Title

Open Pre-Peritoneal Repair ( Open PP group)

Arm Type

Active Comparator

Arm Description

Both hernias were treated by open pre-peritoneal single mesh repair with suture fixation

Arm Title

Bilateral Lichtenstein repair (LICHT group)

Arm Type

Active Comparator

Arm Description

treated by bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic Trans-Abdominal Pre-Peritoneal

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Open pre-peritoneal repair

Intervention Description

Open pre-peritoneal single mesh repair with suture fixation

Intervention Type

Procedure

Intervention Name(s)

Bilateral Lichtenstein repair

Intervention Description

Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation

Primary Outcome Measure Information:

Title

Operative time

Description

Operative time (in minutes)

Time Frame

From skin incision until incision closure at the end of surgery

Title

Postoperative pain after 24 hours

Description

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)

Time Frame

24 hours after surgery

Title

Postoperative pain after 7 days

Description

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)

Time Frame

7 days after surgery

Title

Early postoperative complications

Description

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

Time Frame

Within 30 days after the surgery

Secondary Outcome Measure Information:

Title

Chronic Groin pain

Description

Groin pain lasting for more than 3 months after surgery

Time Frame

After 3 months postoperatively

Title

3 years hernia recurrence rate

Description

Unilateral or bilateral - residual or recurrent hernia

Time Frame

within 3 years after surgery

Title

Patient's satisfaction score

Description

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

Time Frame

within 3 years after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed Elmessiry, MD, PhD

Organizational Affiliation

Assistant Professor of Surgery

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

11525372

Citation

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.

Results Reference

background

PubMed Identifier

20960019

Citation

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.

Results Reference

background

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Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia

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