Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery

Not Applicable

Completed

• Conditions: Low Anterior Resection Syndrome
• Interventions: Drug: Medication; Device: Transanal irrigation

• Registration Number: NCT03215017
• Lead Sponsor: Mirna Abraham-Nordling

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 Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2017-07-01
• Study First Submitted QC: 2017-07-09
• Study First Posted: 2017-07-12
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medication	Medication	Medication to control bowel function.
Transanal irrigation	Transanal irrigation	Manual transanal irrigation to control bowel function.

Primary Outcome Measures

Name	Time	Method
Bowel function	1 year	Cleveland incontinence questionnaire
Bowel function, Low anterior resection syndrome (LARS)	1 year	Assessed using LARS questionnaire (score 0-42, a high score indicates poor bowel function)

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QoL)	1 year	Assessed using EORTC Quality of life questionnaire (QLQ)-C30

Trial Locations

Locations (3)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Stockholm South General Hospital; 🇸🇪 Stockholm, Sweden

Danderyd Hospital; 🇸🇪 Stockholm, Sweden