Comparison of Mesh Fixation Wit Cyanoacrylate vs Suture in Inguinal Hernia Surgery (UHU)
July 21, 2014 updated by: José A. Pereira, Hospital del Mar
Cyanoacrylate vs Suture for Mesh Fixation in Inguinal Hernia Surgery
To compare fixation with glubran2 with suture during surgery por primary inguinal hernia.
Hypothesis: Glue may induce less complications and chronic pain than suture
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male patients
- Aged more than 18 years
- Primary inguinal hernia
Exclusion Criteria:
- Inguinoscrotal hernia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Glue
Mesh fixation with glue
|
|
|
ACTIVE_COMPARATOR: Suture
Mesh fixation with suture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Chronic pain after two years
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: JA Pereira, MD, Hospital del Mar
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (ACTUAL)
June 1, 2011
Study Completion (ACTUAL)
June 1, 2011
Study Registration Dates
First Submitted
July 21, 2014
First Submitted That Met QC Criteria
July 21, 2014
First Posted (ESTIMATE)
July 22, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
July 22, 2014
Last Update Submitted That Met QC Criteria
July 21, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.