A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mirna Abraham-Nordling
- Enrollment
- 45
- Locations
- 3
- Primary Endpoint
- Bowel function
Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •recurrent disease
- •Another colorectal surgery
- •Inflammatory bowel disease (IBD)
Arms & Interventions
Transanal irrigation
Manual transanal irrigation to control bowel function.
Intervention: Transanal irrigation (Device)
Medication
Medication to control bowel function.
Intervention: Medication (Drug)
Outcomes
Primary Outcomes
Bowel function
Time Frame: 1 year
Cleveland incontinence questionnaire
Bowel function, Low anterior resection syndrome (LARS)
Time Frame: 1 year
Assessed using LARS questionnaire (score 0-42, a high score indicates poor bowel function)
Secondary Outcomes
- Quality of Life (QoL)(1 year)
Investigators
Mirna Abraham-Nordling
MD. PhD. Associate Professor of Surgery
Karolinska Institutet