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

March 12, 2024 updated by: Anna-Maria Thölix, Helsinki University Central Hospital
Self-fixed mesh and postoperative pain after laparoscopic inguinal hernia surgery, a randomized clinical trial

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Espoo, Finland
        • Helsinki ja uudenmaan sairaalhoitopiiri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Self-adhesive mesh
Device: Adhesix mesh
2 meshes are used; the self-gripping Progrip mesh and the self-adhesive Adhesix mesh
Other Names:
  • Progrip mesh
Active Comparator: Self-gripping mesh
Device: Adhesix mesh
2 meshes are used; the self-gripping Progrip mesh and the self-adhesive Adhesix mesh
Other Names:
  • Progrip mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during the first post-operative week
Time Frame: 1 year
The degree of pain (VAS score) and the use of pain medication during the first postoperative week
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2021

Primary Completion (Actual)

July 31, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS/3413/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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