Laparoscopic vs Open Bilateral Inguinal Hernia Repair

NCT ID: NCT04679116

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-02

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inguinal Hernia Bilateral

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

prospective, non randomised
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic

laparoscopic inguinal hernia repair, TAPP

Group Type OTHER

Laparoscopic bilateral inguinal hernia repair

Intervention Type PROCEDURE

Laparoscopic bilateral inguinal hernia repair

Open

open inguinal hernia repair

Group Type OTHER

Open bilateral inguinal hernia repair

Intervention Type PROCEDURE

Open bilateral inguinal hernia repair

Interventions

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Laparoscopic bilateral inguinal hernia repair

Laparoscopic bilateral inguinal hernia repair

Intervention Type PROCEDURE

Open bilateral inguinal hernia repair

Open bilateral inguinal hernia repair

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* bilateral inguinal hernia

Exclusion Criteria

* American Society of Anaesthesiology score \>3
* complicated inguinal hernias
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Larissa

OTHER

Sponsor Role lead

Responsible Party

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Georgios Koukoulis

General Surgery Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios D Koukoulis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Larissa

Locations

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General Hospital Of Larissa

Larissa, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Georgios D Koukoulis, MD, PhD

Role: CONTACT

00302413504366

Facility Contacts

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Georgios Koukoulis, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 29330835 (View on PubMed)

Other Identifiers

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1726

Identifier Type: -

Identifier Source: org_study_id

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