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Laparoscopic vs Open Bilateral Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia Bilateral

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Laparoscopic bilateral inguinal hernia repair
Open bilateral inguinal hernia repair
Sponsored by
General Hospital of Larissa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia Bilateral focused on measuring bilateral inguinal hernia repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • bilateral inguinal hernia

Exclusion Criteria:

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

Sites / Locations

  • General Hospital Of LarissaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Laparoscopic

Open

Arm Description

laparoscopic inguinal hernia repair, TAPP

open inguinal hernia repair

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

days of hospitalization
days that need to be hospitalised after surgery
urinary retention
inability to voluntarily void urine up to 8 hours post surgery
complications
presence of surgery related complications
recurrence
recurrence of one or two of the hernias treated at the clinical evaluation one year after surgery
chronic pain
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)
foreign body sensation to the inguinal area
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)

Full Information

First Posted
December 11, 2020
Last Updated
February 1, 2021
Sponsor
General Hospital of Larissa
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1. Study Identification

Unique Protocol Identification Number
NCT04679116
Brief Title
Laparoscopic vs Open Bilateral Inguinal Hernia Repair
Official Title
Laparoscopic vs Open Bilateral Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Larissa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia Bilateral
Keywords
bilateral inguinal hernia repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, non randomised
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic
Arm Type
Other
Arm Description
laparoscopic inguinal hernia repair, TAPP
Arm Title
Open
Arm Type
Other
Arm Description
open inguinal hernia repair
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic bilateral inguinal hernia repair
Intervention Description
Laparoscopic bilateral inguinal hernia repair
Intervention Type
Procedure
Intervention Name(s)
Open bilateral inguinal hernia repair
Intervention Description
Open bilateral inguinal hernia repair
Primary Outcome Measure Information:
Title
Post operative Pain
Description
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)
Time Frame
24 hours post surgery
Secondary Outcome Measure Information:
Title
days of hospitalization
Description
days that need to be hospitalised after surgery
Time Frame
30 days
Title
urinary retention
Description
inability to voluntarily void urine up to 8 hours post surgery
Time Frame
8 hours
Title
complications
Description
presence of surgery related complications
Time Frame
30 days
Title
recurrence
Description
recurrence of one or two of the hernias treated at the clinical evaluation one year after surgery
Time Frame
1 year
Title
chronic pain
Description
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)
Time Frame
1 year
Title
foreign body sensation to the inguinal area
Description
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)
Time Frame
1 year

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: bilateral inguinal hernia Exclusion Criteria: American Society of Anaesthesiology score >3 complicated inguinal hernias
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georgios D Koukoulis, MD, PhD
Phone
00302413504366
Email
georgios.koukoulis@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios D Koukoulis, MD, PhD
Organizational Affiliation
General Hospital of Larissa
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital Of Larissa
City
Larissa
ZIP/Postal Code
41221
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgios Koukoulis, MD
Email
georgios.koukoulis@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29330835
Citation
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.
Results Reference
result

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Laparoscopic vs Open Bilateral Inguinal Hernia Repair

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