NCT05091853

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

2.2 years

First QC Date

October 13, 2021

Last Update Submit

October 1, 2024

Conditions

Inguinal HerniaSurgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Self-adhesive mesh

ACTIVE COMPARATOR
Device: Adhesix mesh

Self-gripping mesh

ACTIVE COMPARATOR
Device: Adhesix mesh

Interventions

Adhesix meshDEVICE

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

Also known as: Progrip mesh
Self-adhesive meshSelf-gripping mesh

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with a clinical inguinal hernia, who are operated with laparoscopic surgery in day case surgery

You may not qualify if:

  • scrotal or incarcerated hernia
  • previous laparotomy
  • ASA \>3
  • BMI \<18 or \>35
  • Liver cirrhosis
  • No hernia in clinical examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki ja uudenmaan sairaalhoitopiiri

Espoo, Finland

Location

Related Publications (1)

  • Tholix AM, Kossi J, Gronroos-Korhonen M, Harju J. Laparoscopic inguinal hernia repair with self-fixated meshes: a randomized controlled trial. Surg Endosc. 2025 Apr;39(4):2425-2435. doi: 10.1007/s00464-025-11616-5. Epub 2025 Feb 20.

    PMID: 39979619DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 13, 2021

First Posted

October 25, 2021

Study Start

May 9, 2021

Primary Completion

July 31, 2023

Study Completion

June 30, 2024

Last Updated

October 2, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)