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

Not Applicable

Completed

• Conditions: Inguinal Hernia; Surgery
• Interventions: Device: Adhesix mesh

• Registration Number: NCT05091853
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-05-09
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-25
• Primary Completion: 2023-07-31
• Study Completion: 2024-06-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-adhesive mesh	Adhesix mesh	-
Self-gripping mesh	Adhesix mesh	-

Primary Outcome Measures

Name	Time	Method
Pain during the first post-operative week	1 year	The degree of pain (VAS score) and the use of pain medication during the first postoperative week

Trial Locations

Locations (1)

Helsinki ja uudenmaan sairaalhoitopiiri; 🇫🇮 Espoo, Finland