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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: |
NCT01313026 |
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Date of registration:
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07/01/2011 |
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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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Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation
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Scientific title:
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Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation. A Randomized Cross Over Study. |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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14 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01313026 |
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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: Crossover 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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Denmark
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Contacts
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Name:
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Katrine J. Emmertsen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Aarhus |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Low anterior resection for rectal cancer between May 2001 and May 2011
Exclusion Criteria:
- Non-radical resection
- metastatic disease
- Chemotherapy
- Radiotherapy
- Previously treated for another cancer
- Dementia or other mental retardation/severe mental disease
- Inability to read and understand the Danish language
- Recurrent disease
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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Rectal Cancer
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Intervention(s)
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Procedure: Percutaneous nerve evaluation
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Primary Outcome(s)
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changes in LARS score
[Time Frame: baseline, 12, 16, 20, 24 and 28 weeks]
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Secondary Outcome(s)
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Incontinence
[Time Frame: baseline, 12, 16, 20, 24 and 28 weeks]
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Sexual function
[Time Frame: baseline, 12, 16, 20, 24 and 28 weeks]
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Patient Satisfaction
[Time Frame: baseline, 12, 16, 20, 24 and 28 weeks]
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Bladder function
[Time Frame: baseline, 12, 16, 20, 24 and 28 weeks]
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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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