- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04679116
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
-
-
-
Larissa, Greece, 41221
- Recruiting
- General Hospital of Larissa
-
Contact:
- Georgios Koukoulis, MD
- Email: georgios.koukoulis@gmail.com
-
-
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
|
Laparoscopic bilateral inguinal hernia repair
|
Other: Open
open 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
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.
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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