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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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20 March 2023 |
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Main ID: |
NCT03215017 |
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Date of registration:
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01/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery
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Scientific title:
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A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery |
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Date of first enrolment:
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May 15, 2017 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03215017 |
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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: 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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Sweden
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Contacts
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Name:
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Mirna Abraham-Nordling, MD.PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Institutet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients that have undergone surgery for rectal cancer (sphincter saving surgery, low
anterior resection)
- Adult = 18 years old
- Have scoring major LARS (according to the Low anterior resection syndrome score)
Exclusion Criteria:
- stoma
- recurrent disease
- Another colorectal surgery
- Inflammatory bowel disease (IBD)
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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Low Anterior Resection Syndrome
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Intervention(s)
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Device: Transanal irrigation
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Drug: Medication
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Primary Outcome(s)
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Bowel function
[Time Frame: 1 year]
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Bowel function, Low anterior resection syndrome (LARS)
[Time Frame: 1 year]
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Secondary Outcome(s)
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Quality of Life (QoL)
[Time Frame: 1 year]
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Secondary ID(s)
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2017/551-31
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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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