Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
160 participants
INTERVENTIONAL
2023-03-29
2026-05-29
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tissue adhesive
Group of 80 patients in which mesh fixation is done using cyanoacrylate glue
Use of n-hexyl cyanoacrylate for mesh fixation
Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair
Standard suture
Group of 80 patients who undergo hernioplasty with standard suture
No interventions assigned to this group
Interventions
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Use of n-hexyl cyanoacrylate for mesh fixation
Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hospital Universitario de Móstoles
OTHER
Responsible Party
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Justyna Drewniak Jakubowska
Surgeon
Locations
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Hospital Universitario de Móstoles
Móstoles, Madrid, Spain
Countries
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Other Identifiers
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HUMostoles
Identifier Type: -
Identifier Source: org_study_id
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