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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: |
NCT02489175 |
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Date of registration:
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17/06/2015 |
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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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Stomaplasty Ring (KoringTM) for Prevention of Parastomal Hernia
StoKo |
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Scientific title:
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International Prospective Randomized Multicenter Trial to Analyze the Stomaplasty Ring (KoringTM) for Prevention of Parastomal Hernia |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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4 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02489175 |
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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: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Dieter Hahnloser, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire Vaudois (CHUV) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients requiring permanent ostomy (ileo- or colostomy) for a malignant tumour with
at least one year life expectancy
- Patient is able to cooperate
- Patient has given written informed consent
- Age equal or greater than 18 years
Exclusion Criteria:
- Life expectancy < 1 year
- Palliative surgery
- Benign disease
- Factors impacting on the ability to cooperate
- Mental disorders
- Pregnant or breastfeeding women
- Participation in another intervention trial with interference of intervention and
outcome of this study
- BMI < 18
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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Parastomal Hernia
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Intervention(s)
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Device: Stomaplasty KoringTM
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Primary Outcome(s)
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Parastomal hernia rate
[Time Frame: at 12 months]
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Secondary Outcome(s)
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Stoma necrosis
[Time Frame: 30 postoperative days, 12 and 24 months]
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Surgical site infection
[Time Frame: 30 postoperative days, 12 and 24 months]
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Stoma retraction
[Time Frame: 30 postoperative days, 12 and 24 months]
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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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