Groin HerniaPhase 4NCT05934266
Impact of Mesh Fixation With Tissue Adhesive
A Phase 4 study testing Use of n-hexyl cyanoacrylate for mesh fixation in people with Groin Hernia and Hernia, Inguinal, run by Hospital Universitario de Móstoles at 1 site in Spain.
Trial summary
Randomized controlled trial on mesh fixation using cyanoacrylate glue compared to standard suture in open inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Groin Hernia, Hernia, Inguinal, Postoperative Pain
- What is being tested?
- Use of n-hexyl cyanoacrylate for mesh fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 29 Mar 2023to 29 May 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective open inguinal hernioplasty in patients over 18 years old
Who cannot join
- Patient refusal
- Laparoscopic surgery
- Reintervention surgery
- Urgent surgery
- Cyanoacrylate allergy
- Administration of intraoperative local anesthetics
- Comorbidities that may affect the requirements of analgesics, such as degenerative arthropathies, fibromyalgia, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Mesh Fixation With Tissue Adhesive on Open Inguinal Hernia Repair
Randomized controlled trial on mesh fixation using cyanoacrylate glue compared to standard suture in open inguinal hernia repair.
Read the detailed description
Hernioplasty with suture-fixed mesh is the standard technique for the treatment of inguinal hernia, one of the most frequent pathologies in the Surgery Service. Despite its good results in terms of recurrences, it is currently under review due to the incidence of chronic postoperative pain. Up to half of the patients report some type of pain at one year of follow-up, and 15% report moderate-severe pain.
The objective of the study is to analyze whether the use of tissue adhesive (n-hexyl cyanoacrylate 0.5 ml) for mesh fixation in patients undergoing scheduled open inguinal hernioplasty results in a better postoperative evolution, with less chronic pain and less demand for analgesia, compared with a control group of patients who undergo the same surgical intervention with standard suture repair.
- Conditions
- Groin Hernia, Hernia, Inguinal, Postoperative Pain, Neuropathic Pain
- Being tested
- Use of n-hexyl cyanoacrylate for mesh fixation
- Keywords
- hernioplasty, mesh fixation, n-hexyl cyanoacrylate, groin hernia, postoperative pain
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of n-hexyl cyanoacrylate for mesh fixationDevice
Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Tissue adhesive | Experimental | Group of 80 patients in which mesh fixation is done using cyanoacrylate glue Receives: Device: Use of n-hexyl cyanoacrylate for mesh fixation |
| Standard suture | No intervention | Group of 80 patients who undergo hernioplasty with standard suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain assessed by visual numeric scale
Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.
Measured: 6 months
Postoperative administration of analgesics
Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements
Measured: 6 months
Secondary outcomes (2)
Hernia recurrence
Hernia recurrence rate after mesh fixation with tissue adhesive
Measured: 6 months
Hematoma
Groin hematoma following hernioplasty with n-hexyl cyanoacrylate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start29 Mar 2023
- Primary completion1 May 2025
- Study completion29 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Groin HerniaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Móstoles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justyna Drewniak Jakubowska, Hospital Universitario de Móstoles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934266
- Sponsor's protocol ID
- HUMostoles
- Status last verified
- May 2025
- First submitted
- 12 Jun 2023
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mesh Fixation With Tissue Adhesive on Open Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT05934266
- Acronym / sponsor ID
- HUMostoles
- Conditions
- Groin Hernia, Hernia, Inguinal, Postoperative Pain, Neuropathic Pain
- Keywords
- hernioplasty, mesh fixation, n-hexyl cyanoacrylate, groin hernia, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hospital Universitario de MóstolesUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 29 May 2026 (estimated)
- First posted
- 6 Jul 2023 (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.
Randomized controlled trial on mesh fixation using cyanoacrylate glue compared to standard suture in open inguinal hernia repair.
Detailed description
Hernioplasty with suture-fixed mesh is the standard technique for the treatment of inguinal hernia, one of the most frequent pathologies in the Surgery Service. Despite its good results in terms of recurrences, it is currently under review due to the incidence of chronic postoperative pain. Up to half of the patients report some type of pain at one year of follow-up, and 15% report moderate-severe pain.
The objective of the study is to analyze whether the use of tissue adhesive (n-hexyl cyanoacrylate 0.5 ml) for mesh fixation in patients undergoing scheduled open inguinal hernioplasty results in a better postoperative evolution, with less chronic pain and less demand for analgesia, compared with a control group of patients who undergo the same surgical intervention with standard suture repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tissue adhesive | Experimental | Device: Use of n-hexyl cyanoacrylate for mesh fixationGroup of 80 patients in which mesh fixation is done using cyanoacrylate glue |
| Standard suture | No intervention | –Group of 80 patients who undergo hernioplasty with standard suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective open inguinal hernioplasty in patients over 18 years old
Key exclusion criteria (7 listed)
- Patient refusal
- Laparoscopic surgery
- Reintervention surgery
- Urgent surgery
- Cyanoacrylate allergy
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 |
|---|---|---|
| Use of n-hexyl cyanoacrylate for mesh fixationMesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair | Device | Tissue adhesive |
Primary outcome
Postoperative pain assessed by visual numeric scale
Time frame: 6 months
Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.
Postoperative administration of analgesics
Time frame: 6 months
Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements
2 secondary outcomes
Hernia recurrence
Time frame: 6 months
Hematoma
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
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Comparing Two Laparoscopic Techniques for Hernia Repair in Children
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Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
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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 Phase 4 study testing Use of n-hexyl cyanoacrylate for mesh fixation in people with Groin Hernia and Hernia, Inguinal, run by Hospital Universitario de Móstoles at 1 site in Spain.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 2 May 2025. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative pain assessed by visual numeric scale (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2025.