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NCT05091853 Clinical Trial

Laparscopic Inguinal Hernia Repair - Does the Choice of Self-fixated Mesh Matter?

Surgery Clinical Trial

Official title:
Laparscopic Inguinal Hernia Repair - Does the Choice of Self-fixated Mesh Matter?

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05091853
Other study ID # HUS/3413/2020
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 9, 2021
Est. completion date June 30, 2024

Study information
Verified date March 2024
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Self-fixed mesh and postoperative pain after laparoscopic inguinal hernia surgery, a randomized clinical trial

Description:

Pain after inguinal hernia surgery is a major problem for the patient and results in lower quality of life. In this randomized clinical trial we examine if the choice of self-fixed mesh affects post-operative inguinal pain in laparoscopic hernia surgery. 164 patients are randomized and followed up for 1 year.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 164
Est. completion date June 30, 2024
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - patients with a clinical inguinal hernia, who are operated with laparoscopic surgery in day case surgery Exclusion Criteria: - scrotal or incarcerated hernia - previous laparotomy - ASA >3 - BMI <18 or >35 - Liver cirrhosis - No hernia in clinical examination

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Adhesix mesh
2 meshes are used; the self-gripping Progrip mesh and the self-adhesive Adhesix mesh

Locations
Country Name City State
Finland Helsinki ja uudenmaan sairaalhoitopiiri Espoo

Sponsors (1)
Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain during the first post-operative week The degree of pain (VAS score) and the use of pain medication during the first postoperative week 1 year
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