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A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.
A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer.
The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.
An interim analysis will be made after 40 included patients in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transanal irrigation | Experimental | Manual transanal irrigation to control bowel function. |
|
| Medication | Active Comparator | Medication to control bowel function. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transanal irrigation | Device | Effect of Transanal irrigation (TAI) using PeristeenĀ® anal irrigation system - Coloplast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bowel function | Cleveland incontinence questionnaire | 1 year |
| Bowel function, Low anterior resection syndrome (LARS) | Assessed using LARS questionnaire (score 0-42, a high score indicates poor bowel function) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QoL) | Assessed using EORTC Quality of life questionnaire (QLQ)-C30 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mirna Abraham-Nordling, MD.PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danderyd Hospital | Stockholm | Sweden | ||||
| Karolinska University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35797618 | Background | Pieniowski EHA, Bergstrom CM, Nordenvall CAM, Westberg KS, Johar AM, Tumlin Ekelund SF, Larsson KR, Pekkari KJ, Jansson Palmer GC, Lagergren P, Abraham-Nordling M. A Randomized Controlled Clinical Trial of Transanal Irrigation Versus Conservative Treatment in Patients With Low Anterior Resection Syndrome After Rectal Cancer Surgery. Ann Surg. 2023 Jan 1;277(1):30-37. doi: 10.1097/SLA.0000000000005482. Epub 2022 Jul 7. |
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| ID | Term |
|---|---|
| D000094123 | Low Anterior Resection Syndrome |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D013012 | Sorbitol |
| D007618 | Karaya Gum |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D013402 | Sugar Alcohols |
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| Medication | Drug | Medication to help control of the bowel movement (One or a combination of Loperamide, Sorbitol, Sterculia gum) |
|
|
| Stockholm |
| Sweden |
| Stockholm South General Hospital | Stockholm | Sweden |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |