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

NCT ID: NCT05091853

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-09

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inguinal Hernia Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Self-adhesive mesh

Group Type ACTIVE_COMPARATOR

Adhesix mesh

Intervention Type DEVICE

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

Self-gripping mesh

Group Type ACTIVE_COMPARATOR

Adhesix mesh

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adhesix mesh

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Progrip mesh

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anna-Maria Thölix

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Helsinki ja uudenmaan sairaalhoitopiiri

Espoo, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39979619 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HUS/3413/2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Impact of Mesh Fixation With Tissue Adhesive
NCT05934266 ACTIVE_NOT_RECRUITING PHASE4
Chronic Pain After Inguinal Hernia Repair
NCT00820131 COMPLETED PHASE4