Inguinal HerniaNCT05091853
Laparscopic Inguinal Hernia Repair - Does the Choice of Self-fixated Mesh Matter?
A study testing Adhesix mesh in people with Inguinal Hernia and Surgery, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Self-fixed mesh and postoperative pain after laparoscopic inguinal hernia surgery, a randomized clinical trial Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inguinal Hernia, Surgery
- What is being tested?
- Adhesix mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteFinland
- Study dates
- 9 May 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a clinical inguinal hernia, who are operated with laparoscopic surgery in day case surgery
Who cannot join
- scrotal or incarcerated hernia
- previous laparotomy
- ASA >3
- BMI <18 or >35
- Liver cirrhosis
- No hernia in clinical examination
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Inguinal Hernia, Surgery
- Being tested
- Adhesix mesh
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhesix meshDevice
Also called Progrip mesh
2 meshes are used; the self-gripping Progrip mesh and the self-adhesive Adhesix mesh
| Study group | Role | What they receive |
|---|---|---|
| Self-adhesive mesh | Active comparator | Not described Receives: Device: Adhesix mesh |
| Self-gripping mesh | Active comparator | Not described Receives: Device: Adhesix mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during the first post-operative week
The degree of pain (VAS score) and the use of pain medication during the first postoperative week
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start9 May 2021
- Primary completion31 Jul 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna-Maria Thölix, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091853
- Sponsor's protocol ID
- HUS/3413/2020
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2021
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparscopic Inguinal Hernia Repair - Does the Choice of Self-fixated Mesh Matter?
- ClinicalTrials.gov ID
- NCT05091853
- Acronym / sponsor ID
- HUS/3413/2020
- Conditions
- Inguinal Hernia, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 9 May 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-adhesive mesh | Active comparator | Device: Adhesix mesh |
| Self-gripping mesh | Active comparator | Device: Adhesix mesh |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with a clinical inguinal hernia, who are operated with laparoscopic surgery in day case surgery
Key exclusion criteria (6 listed)
- scrotal or incarcerated hernia
- previous laparotomy
- ASA >3
- BMI <18 or >35
- Liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adhesix meshAlso: Progrip mesh2 meshes are used; the self-gripping Progrip mesh and the self-adhesive Adhesix mesh | Device | Self-adhesive mesh, Self-gripping mesh |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Derived from this study: PubMed 39979619Tholix 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adhesix mesh in people with Inguinal Hernia and Surgery, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during the first post-operative week (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05091853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.