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CompletedNCT05091853Updated Oct 2, 2024

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

An interventional study of Adhesix mesh in Inguinal Hernia and Surgery, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled May 2021, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
174
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Inguinal Hernia
  • Surgery

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03

In context

Hernia, Inguinal

561 studies on the registry are indexed under Hernia, Inguinal; 76 are open to participants now.

This study's enrollment of 174 is above the median of 90 across 414 interventional studies indexed under Hernia, Inguinal.

Browse Hernia, Inguinal studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • scrotal or incarcerated hernia
  • previous laparotomy
  • ASA >3
  • BMI \<18 or >35
  • Liver cirrhosis
  • No hernia in clinical examination
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
174 participants (actual)

Study arms

  • Active comparator
    Self-adhesive mesh

    Device: Adhesix mesh

  • Active comparator
    Self-gripping mesh

    Device: Adhesix mesh

Interventions

  • DeviceAdhesix mesh

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

    Also known as: Progrip mesh

06

What researchers measure

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

    Time frame: 1 year

07

Study locations

1 site
  • Helsinki ja uudenmaan sairaalhoitopiiri
    Espoo, Finland
08

References and documents

Publications

  • 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. PubMed 39979619 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05091853
Responsible party
Anna-Maria Thölix (MD, Helsinki University Central Hospital) — Principal investigator
First posted
Oct 25, 2021
Start date
May 9, 2021
Primary completion
Jul 31, 2023
Completion
Jun 30, 2024
Last update
Oct 2, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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