The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair
NCT ID: NCT01596049
Last Updated: 2017-08-22
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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TERMINATED
7 participants
OBSERVATIONAL
2012-05-31
2017-08-31
Brief Summary
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The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.
The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).
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Detailed Description
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The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.
The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).
The data will be compared to the literature and will be statistically analysed. The follow-up for each patient will be two years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Self-fixating Mesh
patients attributed to that arm, undergoing surgery of open inguinal unilateral hernia repair, using Self-fixating Mesh which is acceptable in the literature.
Self-fixating Mesh
Using Self-fixating Mesh for Inguinal Hernia Repair
Interventions
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Self-fixating Mesh
Using Self-fixating Mesh for Inguinal Hernia Repair
Eligibility Criteria
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Inclusion Criteria
* patients undergoing elective surgery.
* above the age of 18 years old
Exclusion Criteria
* patients having bilateral Hernia.
* patients undergoing laparoscopic surgery.
* patients undergoing non-elective surgery.
18 Years
90 Years
MALE
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Principal Investigators
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Adel Abu_Salih, M.D
Role: PRINCIPAL_INVESTIGATOR
Rambam health care campus, Haifa, Israel
Locations
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Rambam health care campus
Haifa, , Israel
Countries
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Other Identifiers
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hernia313-11-RMBCTIL
Identifier Type: -
Identifier Source: org_study_id
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