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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04679116
Other study ID # 1726
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2, 2021
Est. completion date December 2022

Study information

Verified date February 2021
Source General Hospital of Larissa
Contact Georgios D Koukoulis, MD, PhD
Phone 00302413504366
Email georgios.koukoulis@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. We will conduct a prospective, non randomise control trial, to investigate the superiority of one technique over the other.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - bilateral inguinal hernia Exclusion Criteria: - American Society of Anaesthesiology score >3 - complicated inguinal hernias

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Laparoscopic bilateral inguinal hernia repair
Laparoscopic bilateral inguinal hernia repair
Open bilateral inguinal hernia repair
Open bilateral inguinal hernia repair

Locations

Country Name City State
Greece General Hospital Of Larissa Larissa

Sponsors (1)

Lead Sponsor Collaborator
General Hospital of Larissa

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 24 hours post surgery
Secondary days of hospitalization days that need to be hospitalised after surgery 30 days
Secondary urinary retention inability to voluntarily void urine up to 8 hours post surgery 8 hours
Secondary complications presence of surgery related complications 30 days
Secondary recurrence recurrence of one or two of the hernias treated at the clinical evaluation one year after surgery 1 year
Secondary 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) 1 year
Secondary 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) 1 year
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