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

March 7, 2023 updated by: Mirna Abraham-Nordling

A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital
      • Stockholm, Sweden
        • Stockholm South General Hospital
      • Stockholm, Sweden
        • Danderyd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transanal irrigation
Manual transanal irrigation to control bowel function.
Device: Transanal irrigation
Effect of Transanal irrigation (TAI) using Peristeen® anal irrigation system - Coloplast
Other Names:
  • Peristeen® anal irrigation system - Coloplast
Active Comparator: Medication
Medication to control bowel function.
Drug: Medication
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel function
Time Frame: 1 year
Cleveland incontinence questionnaire
1 year
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)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QoL)
Time Frame: 1 year
Assessed using EORTC Quality of life questionnaire (QLQ)-C30
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mirna Abraham-Nordling

Investigators

  • Principal Investigator: Mirna Abraham-Nordling, MD.PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

July 1, 2017

First Submitted That Met QC Criteria

July 9, 2017

First Posted (Actual)

July 12, 2017

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/551-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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