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

Sponsor
Mirna Abraham-Nordling (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03215017
Collaborator
(none)
100
Enrollment
3
Locations
2
Arms
66.6
Anticipated Duration (Months)
33.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery
Actual Study Start Date :
May 15, 2017
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bowel function [1 year]

      Cleveland incontinence questionnaire

    2. 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

    1. Quality of Life (QoL) [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:

    • stoma

    • recurrent disease

    • Another colorectal surgery

    • Inflammatory bowel disease (IBD)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Danderyd Hospital Stockholm Sweden
    2 Karolinska University Hospital Stockholm Sweden
    3 Stockholm South General Hospital Stockholm Sweden

    Sponsors and Collaborators

    • Mirna Abraham-Nordling

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mirna Abraham-Nordling, MD. PhD. Associate Professor of Surgery, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT03215017
    Other Study ID Numbers:
    • 2017/551-31
    First Posted:
    Jul 12, 2017
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    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
    Additional relevant MeSH terms:
    Syndrome
    Loperamide
    Sorbitol

    Study Results

    No Results Posted as of Aug 23, 2022