Laparoscopic vs Open Bilateral Inguinal Hernia Repair
- 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
- bilateral inguinal hernia
- American Society of Anaesthesiology score >3
- complicated inguinal hernias
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Post operative Pain 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)
- Secondary Outcome Measures
Name Time Method urinary retention 8 hours inability to voluntarily void urine up to 8 hours post surgery
foreign body sensation to the inguinal area 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)
days of hospitalization 30 days days that need to be hospitalised after surgery
chronic pain 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)
complications 30 days presence of surgery related complications
recurrence 1 year recurrence of one or two of the hernias treated at the clinical evaluation one year after surgery
Related Research Topics
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Trial Locations
- Locations (1)
General Hospital Of Larissa
🇬🇷Larissa, Greece
General Hospital Of Larissa🇬🇷Larissa, GreeceGeorgios Koukoulis, MDContactgeorgios.koukoulis@gmail.com