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Laparoscopic vs Open Bilateral Inguinal Hernia Repair

Not Applicable
Conditions
Inguinal Hernia Bilateral
Registration Number
NCT04679116
Lead Sponsor
General Hospital of Larissa
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Male
Target Recruitment
100
Inclusion Criteria
  • bilateral inguinal hernia
Exclusion Criteria
  • American Society of Anaesthesiology score >3
  • complicated inguinal hernias

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Post operative Pain24 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)

Secondary Outcome Measures
NameTimeMethod
urinary retention8 hours

inability to voluntarily void urine up to 8 hours post surgery

foreign body sensation to the inguinal area1 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)

days of hospitalization30 days

days that need to be hospitalised after surgery

chronic pain1 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)

complications30 days

presence of surgery related complications

recurrence1 year

recurrence of one or two of the hernias treated at the clinical evaluation one year after surgery

Trial Locations

Locations (1)

General Hospital Of Larissa

🇬🇷

Larissa, Greece

General Hospital Of Larissa
🇬🇷Larissa, Greece
Georgios Koukoulis, MD
Contact
georgios.koukoulis@gmail.com

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