Laparoscopic vs Open Bilateral Inguinal Hernia Repair

February 1, 2021 updated by: Georgios Koukoulis, General Hospital of Larissa
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • bilateral inguinal hernia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Laparoscopic
laparoscopic inguinal hernia repair, TAPP
Procedure: Laparoscopic bilateral inguinal hernia repair
Laparoscopic bilateral inguinal hernia repair
Other: Open
open inguinal hernia repair
Procedure: Open bilateral inguinal hernia repair
Open bilateral inguinal hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative Pain
Time Frame: 24 hours post surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
days of hospitalization
Time Frame: 30 days
days that need to be hospitalised after surgery
30 days
urinary retention
Time Frame: 8 hours
inability to voluntarily void urine up to 8 hours post surgery
8 hours
complications
Time Frame: 30 days
presence of surgery related complications
30 days
recurrence
Time Frame: 1 year
recurrence of one or two of the hernias treated at the clinical evaluation one year after surgery
1 year
chronic pain
Time Frame: 1 year
For the evaluation of the chronic pain will be used the registry for abdominal wall hernias Quality of Life questionnaire (EuraHS QoL) scale from 0 to 10. (0 = no pain 10=worst pain imaginable)
1 year
foreign body sensation to the inguinal area
Time Frame: 1 year
For the evaluation of the foreign body sensation to the inguinal area will be used the Carolinas Comfort Scale (scale from 0 to 5, 0= no symptoms, 5 = disabling symptoms)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Larissa

Investigators

  • Principal Investigator: Georgios D Koukoulis, MD, PhD, General Hospital of Larissa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

December 17, 2020

First Posted (Actual)

December 22, 2020

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1726

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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