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

Primary Purpose

Inguinal Hernia, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Adhesix mesh
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki ja uudenmaan sairaalhoitopiiriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Self-adhesive mesh

Self-gripping mesh

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 13, 2021
Last Updated
February 28, 2023
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05091853
Brief Title
Laparscopic Inguinal Hernia Repair - Does the Choice of Self-fixated Mesh Matter?
Official Title
Laparscopic Inguinal Hernia Repair - Does the Choice of Self-fixated Mesh Matter?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-adhesive mesh
Arm Type
Active Comparator
Arm Title
Self-gripping mesh
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Adhesix mesh
Other Intervention Name(s)
Progrip mesh
Intervention Description
2 meshes are used; the self-gripping Progrip mesh and the self-adhesive Adhesix mesh
Primary Outcome Measure Information:
Title
Pain during the first post-operative week
Description
The degree of pain (VAS score) and the use of pain medication during the first postoperative week
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna-Maria Thölix, MD
Phone
+358094711
Email
anna-maria.tholix@hus.fi
Facility Information:
Facility Name
Helsinki ja uudenmaan sairaalhoitopiiri
City
Espoo
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna-Maria Thölix, MD
Phone
+35894711
Email
anna-maria.tholix@hus.fi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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