Laparoscopic vs Open Bilateral Inguinal Hernia Repair

Inguinal Hernia Bilateral Clinical Trial

Official title:

Laparoscopic vs Open Bilateral Inguinal Hernia Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04679116
• Other study ID #: 1726
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia Bilateral

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