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Clinical trial

A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery

ID
Name
2017/551-31
Description
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.
Trial arms
Trial start
2017-05-15
Estimated PCD
2022-12-01
Trial end
2022-12-01
Status
Completed
Treatment
Transanal irrigation
Effect of Transanal irrigation (TAI) using Peristeen® anal irrigation system - Coloplast
Arms:
Transanal irrigation
Other names:
Peristeen® anal irrigation system - Coloplast
Medication
Medication to help control of the bowel movement (One or a combination of Loperamide, Sorbitol, Sterculia gum)
Arms:
Medication
Other names:
One or a combination of Loperamide, Sorbitol, Sterculia gum
Size
45
Primary endpoint
Bowel function
1 year
Bowel function, Low anterior resection syndrome (LARS)
1 year
Eligibility criteria
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}
Updated at
2023-03-09

1 organization

1 product

1 indication

Organization
Mirna Abraham-Nordling
Product
Medication
Indication
Low Anterior Resection Syndrome