NCT04437784

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

3 years

First QC Date

June 16, 2020

Last Update Submit

June 17, 2020

Conditions

Bilateral Inguinal Hernia

Outcome Measures

Primary Outcomes (4)

  • Operative time

    Operative time (in minutes)

    From skin incision until incision closure at the end of surgery

  • 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)

    24 hours after surgery

  • 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)

    7 days after surgery

  • Early postoperative complications

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

    Within 30 days after the surgery

Secondary Outcomes (3)

  • Chronic Groin pain

    After 3 months postoperatively

  • 3 years hernia recurrence rate

    within 3 years after surgery

  • Patient's satisfaction score

    within 3 years after surgery

Study Arms (3)

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

ACTIVE COMPARATOR

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

Open Pre-Peritoneal Repair ( Open PP group)

ACTIVE COMPARATOR

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

Procedure: Open pre-peritoneal repair

Bilateral Lichtenstein repair (LICHT group)

ACTIVE COMPARATOR

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

Procedure: Bilateral Lichtenstein repair

Interventions

Laparoscopic Trans-Abdominal Pre-PeritonealPROCEDURE

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

Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group))
Open pre-peritoneal repairPROCEDURE

Open pre-peritoneal single mesh repair with suture fixation

Open Pre-Peritoneal Repair ( Open PP group)
Bilateral Lichtenstein repairPROCEDURE

Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation

Bilateral Lichtenstein repair (LICHT group)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with painless uncomplicated primary bilateral inguinal hernias

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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: 11525372BACKGROUND

  • 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: 20960019BACKGROUND

Study Officials

  • Mohamed Elmessiry, MD, PhD

    Assistant Professor of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Sealed opaque envelopes containing computer generated random numbers
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Surgery

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 18, 2020

Study Start

June 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2020

Last Updated

June 18, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share