Inguinal Hernia BilateralNCT04679116
Laparoscopic vs Open Bilateral Inguinal Hernia Repair
A study testing Laparoscopic bilateral inguinal hernia repair and Open bilateral inguinal hernia repair in people with Inguinal Hernia Bilateral, run by General Hospital of Larissa at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Inguinal Hernia Bilateral
- What is being tested?
- Laparoscopic bilateral inguinal hernia repair and Open bilateral inguinal hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 2 Jan 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral inguinal hernia
Who cannot join
- American Society of Anaesthesiology score >3
- complicated inguinal hernias
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
General Hospital Of Larissa
Larissa, 41221
Georgios Koukoulis, MD, georgios.koukoulis@gmail.com
About this study
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.
- Conditions
- Inguinal Hernia Bilateral
- Being tested
- Laparoscopic bilateral inguinal hernia repair, Open bilateral inguinal hernia repair
- Keywords
- bilateral inguinal hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic bilateral inguinal hernia repairProcedure or surgery
Laparoscopic bilateral inguinal hernia repair
Open bilateral inguinal hernia repairProcedure or surgery
Open bilateral inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic | Other | laparoscopic inguinal hernia repair, TAPP Receives: Procedure: Laparoscopic bilateral inguinal hernia repair |
| Open | Other | open inguinal hernia repair Receives: Procedure: Open bilateral inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours post surgery
Secondary outcomes (6)
days of hospitalization
days that need to be hospitalised after surgery
Measured: 30 days
urinary retention
inability to voluntarily void urine up to 8 hours post surgery
Measured: 8 hours
complications
presence of surgery related complications
Measured: 30 days
recurrence
recurrence of one or two of the hernias treated at the clinical evaluation one year after surgery
Measured: 1 year
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)
Measured: 1 year
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start2 Jan 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal Hernia BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective, non randomised
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Larissa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Koukoulis, General Hospital of Larissa
- Investigators
- Georgios D Koukoulis, MD, PhD, Principal investigator, General Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679116
- Sponsor's protocol ID
- 1726
- Status last verified
- Feb 2021
- First submitted
- 11 Dec 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29330835
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic vs Open Bilateral Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT04679116
- Acronym / sponsor ID
- 1726
- Conditions
- Inguinal Hernia Bilateral
- Keywords
- bilateral inguinal hernia repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General Hospital of LarissaUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, non randomised
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic | Other | Procedure: Laparoscopic bilateral inguinal hernia repairlaparoscopic inguinal hernia repair, TAPP |
| Open | Other | Procedure: Open bilateral inguinal hernia repairopen inguinal hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- bilateral inguinal hernia
Key exclusion criteria (2 listed)
- American Society of Anaesthesiology score >3
- complicated inguinal hernias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic bilateral inguinal hernia repairLaparoscopic bilateral inguinal hernia repair | Procedure or surgery | Laparoscopic |
| Open bilateral inguinal hernia repairOpen bilateral inguinal hernia repair | Procedure or surgery | Open |
Primary outcome
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)
6 secondary outcomes
days of hospitalization
Time frame: 30 days
urinary retention
Time frame: 8 hours
complications
Time frame: 30 days
recurrence
Time frame: 1 year
chronic pain
Time frame: 1 year
foreign body sensation to the inguinal area
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Results publication: PubMed 29330835HerniaSurge 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios D Koukoulis, MD, PhD principal investigator
General Hospital of Larissa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic bilateral inguinal hernia repair and Open bilateral inguinal hernia repair in people with Inguinal Hernia Bilateral, run by General Hospital of Larissa at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgios D Koukoulis, MD, PhD (00302413504366, georgios.koukoulis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative Pain (time frame: 24 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04679116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.