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NCT Number: NCT03215017

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

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.

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Key information

Conditions

Low Anterior Resection Syndrome Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danderyd Hospital, Stockholm, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transanal irrigation

Device

Effect of Transanal irrigation (TAI) using Peristeen® anal irrigation system - Coloplast

Other names: Peristeen® anal irrigation system - Coloplast

medication

Drug

Medication to help control of the bowel movement (One or a combination of Loperamide, Sorbitol, Sterculia gum)

Other names: One or a combination of Loperamide, Sorbitol, Sterculia gum

Primary outcomes

  1. Bowel function

    Time frame: 1 year

    Cleveland incontinence questionnaire

  2. 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

  1. Quality of Life (QoL)

    Time frame: 1 year

    Assessed using EORTC Quality of life questionnaire (QLQ)-C30

Sponsors and collaborators

Lead sponsor

Mirna Abraham-Nordling

Other

Registry information

Official study title

A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2017
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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