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

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-22
• Study Start: 2021-01-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03
• Primary Completion: 2022-12
• Study Completion: 2022-12

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

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

Trial Locations

Locations (1)

General Hospital Of Larissa; 🇬🇷 Larissa, Greece