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

Mirna Abraham-Nordling

Status: Completed

Conditions: Low Anterior Resection Syndrome

Treatments: Drug: Medication; Device: Transanal irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT03215017

2017/551-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Transanal irrigation

Experimental group

Description:

Manual transanal irrigation to control bowel function.

Treatment:

Device: Transanal irrigation

Medication

Active Comparator group

Description:

Medication to control bowel function.

Treatment:

Drug: Medication