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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02712827 |
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Date of registration:
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10/03/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of Different Meshes in Laparoscopic Hernia Repair
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Scientific title:
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A Randomized Controlled Trial Comparing Short Term Outcomes of Self-gripping (Progrip) Mesh With Fibrin Glue Mesh Fixation in Laparoscopic Total Extraperitoneal (TEP) Inguinal Hernia Repair |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02712827 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Hong Kong
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Contacts
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Name:
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Dominic, Chi Chung Foo, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Hong Kong |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age=18
- Unilateral inguinal hernia with large hernia defect size (>3cm)
- Bilateral inguinal hernias
- American Society of Anesthesiologists (ASA) score: 1-2
- Provision of written informed consent
Exclusion Criteria:
- Any prior surgery for ipsilateral inguinal hernia (i.e. recurrent inguinal hernia)
- American Society of Anesthesiologists (ASA) score: 3 or above
- History of major abdominal surgery that may result in difficulty in development of
preperitoneal space
- Subject is pregnant or breast feeding
- Any serious concomitant illness with short life expectancy
- Subject who is not able to attend follow up postoperatively
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hernia, Inguinal
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Intervention(s)
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Procedure: Progrip
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Procedure: Non-Progrip
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Primary Outcome(s)
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Chronic pain
[Time Frame: 3 months post surgery]
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Secondary Outcome(s)
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mesh deployment time
[Time Frame: 1 day]
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quality of life
[Time Frame: 1 year]
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hernia recurrence rate
[Time Frame: 1 year]
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intraoperative complications
[Time Frame: 1 day]
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Secondary ID(s)
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UW 16-042
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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