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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03215017
Other study ID # 2017/551-31
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2017
Est. completion date December 1, 2022

Study information

Verified date March 2023
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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. An interim analysis will be made after 40 included patients in the study.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transanal irrigation
Effect of Transanal irrigation (TAI) using Peristeen® anal irrigation system - Coloplast
Drug:
Medication
Medication to help control of the bowel movement (One or a combination of Loperamide, Sorbitol, Sterculia gum)

Locations

Country Name City State
Sweden Danderyd Hospital Stockholm
Sweden Karolinska University Hospital Stockholm
Sweden Stockholm South General Hospital Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Mirna Abraham-Nordling

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Bowel function Cleveland incontinence questionnaire 1 year
Primary Bowel function, Low anterior resection syndrome (LARS) Assessed using LARS questionnaire (score 0-42, a high score indicates poor bowel function) 1 year
Secondary Quality of Life (QoL) Assessed using EORTC Quality of life questionnaire (QLQ)-C30 1 year
See also
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