Clinical TrialID 2586
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
NCT04087421
Low Anterior Resection Syndrome|Rectal Cancer
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 2586
- Evidence Id
- 2586
- Core Evidence Id
- 2586
- Source Clinical Trial Id
- 2565
- Herb2 Clinical Trial Id
- HBCT002565
- Nct Id
- NCT04087421
- Title
- Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
- Status
- Recruiting
- Phase
- Phase 3
- Study Result
- No
- Study Condition
- Low Anterior Resection Syndrome|Rectal Cancer
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DEVICE: Qufora Irrisedo Cone System|DRUG: Glycerol "OBA"
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 114
- Outcome Measure
- Bowel function, change in symptom 1 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score., MYMOP2 is a validated problem-specific, patient-generated questionnaire. Patients are asked to specify one or two symptoms that concern them the most. Subsequently they evaluate the severity on a 7-point Likert scale. The second part of the questionnaire uses the same scale to assess whether the symptom limits or prevent any daily activity, and also to rate general well-being. Follow-up questionnaires address the original issues completed in the initial form. Symptom 1, symptom 2, activity, and wellbeing each have a separate score between 0 and 6 with 0 indicating "as good as it could be" and 6 "as bad as it could be". An overall score is calculated by taking the average of item scores., 12 weeks.
- Sponsor Collaborator
- University of Aarhus
- Funded By
- OTHER
- Location
- Aarhus University Hospital, Department of Surgery, Aarhus, 8200, Denmark
- Other Id
- 676869
- Start Date
- 2019-09-17
- Primary Completion Date
- 2026-12
- Completion Date
- 2026-12
- First Posted
- 2019-09-12
- Results First Posted
- Last Update Posted
- 2023-05-03
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT04087421
- Title Cn
- Title En
- Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
- Bilingual Status
- semi_complete