Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery
A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery
1 other identifier
interventional
45
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2017
CompletedFirst Submitted
Initial submission to the registry
July 1, 2017
CompletedFirst Posted
Study publicly available on registry
July 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 9, 2023
March 1, 2023
5.6 years
July 1, 2017
March 7, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
Quality of Life (QoL)
1 year
Study Arms (2)
Transanal irrigation
EXPERIMENTALManual transanal irrigation to control bowel function.
Medication
ACTIVE COMPARATORMedication to control bowel function.
Interventions
Effect of Transanal irrigation (TAI) using Peristeen® anal irrigation system - Coloplast
Medication to help control of the bowel movement (One or a combination of Loperamide, Sorbitol, Sterculia gum)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- stoma
- recurrent disease
- Another colorectal surgery
- Inflammatory bowel disease (IBD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Danderyd Hospital
Stockholm, Sweden
Karolinska University Hospital
Stockholm, Sweden
Stockholm South General Hospital
Stockholm, Sweden
Related 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.
PMID: 35797618BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mirna Abraham-Nordling, MD.PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD. PhD. Associate Professor of Surgery
Study Record Dates
First Submitted
July 1, 2017
First Posted
July 12, 2017
Study Start
May 15, 2017
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
March 9, 2023
Record last verified: 2023-03