NCT04679116

Brief Summary

The European Hernia Society Guidelines of 2018 suggest that laparoscopic surgery should be preferred over open surgery for bilateral inguinal hernia repair even though scientific evidence are scarce. We will conduct a prospective, non randomise control trial, to investigate the superiority of one technique over the other.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 11, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

January 2, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

1.9 years

First QC Date

December 11, 2020

Last Update Submit

February 1, 2021

Conditions

Inguinal Hernia Bilateral

Keywords

bilateral inguinal hernia repair

Outcome Measures

Primary Outcomes (1)

  • Post operative Pain

    Evaluation of the post operative pain 24 hours after surgery. For the assessment of the pain will be used the Visual Analog Scale (VAS) score. (VAS Score Scale from 0-10, 0 no pain, 10 max pain)

    24 hours post surgery

Secondary Outcomes (6)

  • days of hospitalization

    30 days

  • urinary retention

    8 hours

  • complications

    30 days

  • recurrence

    1 year

  • chronic pain

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Laparoscopic

OTHER

laparoscopic inguinal hernia repair, TAPP

Procedure: Laparoscopic bilateral inguinal hernia repair

Open

OTHER

open inguinal hernia repair

Procedure: Open bilateral inguinal hernia repair

Interventions

Laparoscopic bilateral inguinal hernia repairPROCEDURE

Laparoscopic bilateral inguinal hernia repair

Laparoscopic
Open bilateral inguinal hernia repairPROCEDURE

Open bilateral inguinal hernia repair

Open

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • bilateral inguinal hernia

You may not qualify if:

  • American Society of Anaesthesiology score \>3
  • complicated inguinal hernias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Of Larissa

Larissa, 41221, Greece

RECRUITING

Related Publications (1)

  • HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.

    PMID: 29330835RESULT

Study Officials

  • Georgios D Koukoulis, MD, PhD

    General Hospital of Larissa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios D Koukoulis, MD, PhD

CONTACT

00302413504366georgios.koukoulis@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective, non randomised
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgery Consultant

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 22, 2020

Study Start

January 2, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

February 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)