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Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome (TAILARS)

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ClinicalTrials.gov Identifier: NCT04758195
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Sixth Affiliated Hospital, Sun Yat-sen University

Study Description
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Brief Summary:
Bowel dysfunction after rectal cancer resection comprises a vast array of bowel symptoms and associated quality-of-life impairment, collectively termed as low anterior resection syndrome (LARS). There are 40%-60% patients who suffer from major LARS after sphincter-preserving surgery. No consensus exists for LARS treatment or prevention. Transanal irrigation (TAI) was reported to play a helpful role in the management of major LARS and fecal incontinence. However, the preventive effect and daily accessibility need further confirmation. In this randomized trial, TAI compared with best support treatment, is used in patients who received curative low anterior resection for rectal cancer with diverting stoma, after completion of the stoma reversal. The primary outcome is the occurrence of major LARS after 6 months of the treatment.

Condition or disease Intervention/treatment Phase
Low Anterior Resection Syndrome Procedure: Transanal irrigation Other: Best supportive therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Open, Parallel Trial of Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome in Rectal Cancer Patients
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Transanal irrigation
Transanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months.
 Procedure: Transanal irrigation
Transanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months.
Active Comparator: Best supportive therapy
Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.
 Other: Best supportive therapy
Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with major low anterior resection syndrome score (LARS score) [ Time Frame: at the time of 6 months since the start of treatment ]

Secondary Outcome Measures :
  1. Quality of life impairment assessed by Short Form 36 (SF-36) [ Time Frame: at the time of 6, 12 months since the start of treatment ]
    Quality of life will be assessed by Short Form 36 (SF-36) health questionnaire.

  2. Number of participants with major low anterior resection syndrome score (LARS score) [ Time Frame: at the time of 1, 3, 12 months since the start of treatment ]
  3. Bowel function impairment [ Time Frame: at the time of 6, 12 months since the start of treatment ]
    Bowel function will be assessed by Memorial Sloan Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI). Stool frequency will be recorded in the day and night.

  4. Fecal continence impairment [ Time Frame: at the time of 6, 12 months since the start of treatment ]
    Fecal incontinence will be assessed by Wexner incontinence scale.


Other Outcome Measures:
  1. Anorectal function impairment [ Time Frame: at the time of 6 months since the start of treatment ]
    Anorectal function will be assessed by anorectal manometry.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18-75 years old
  • Curative low anterior resection for rectal cancer with diverting stoma
  • Stoma closure within 1 month
  • Preoperative radiotherapy or height of anastomosis less than 5 cm from anal verge
  • No evidence of anastomotic leakage or severe stenosis

Exclusion Criteria:

  • Tumor recurrence or distant metastasis
  • Secondary operation with stoma
  • Prior disease impairing bowel function except for rectal cancer
  • Any contraindication for transanal irrigation
  • Pregnant or nursing
  • Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease
  • Cognitive or psychological disorder
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758195


Contacts
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Contact: Qiyuan Qin, M.D. 86-20-38254052 qinqy3@mail.sysu.edu.cn

Locations
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China, Guangdong
Sixth Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Qiyuan Qin, M.D.    86-20-38254052    qinqy3@mail.sysu.edu.cn   
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
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Principal Investigator: Qiyuan Qin, M.D. The Sixth Affiliated Hospital, Sun Yat-sen University
More Information
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Responsible Party: Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04758195    
Other Study ID Numbers: E2021004
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sixth Affiliated Hospital, Sun Yat-sen University:
Low Anterior Resection Syndrome
Transanal irrigation
Rectal cancer
Prevention
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes