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

Primary Purpose

Low Anterior Resection Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transanal irrigation
Best supportive therapy
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Anterior Resection Syndrome focused on measuring Low Anterior Resection Syndrome, Transanal irrigation, Rectal cancer, Prevention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transanal irrigation

Best supportive therapy

Arm Description

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.

Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.

Outcomes

Primary Outcome Measures

Number of participants with major low anterior resection syndrome score (LARS score)

Secondary Outcome Measures

Quality of life impairment assessed by Short Form 36 (SF-36)
Quality of life will be assessed by Short Form 36 (SF-36) health questionnaire.
Number of participants with major low anterior resection syndrome score (LARS score)
Bowel function impairment
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.
Fecal continence impairment
Fecal incontinence will be assessed by Wexner incontinence scale.

Full Information

First Posted
February 15, 2021
Last Updated
June 28, 2023
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04758195
Brief Title
Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome
Acronym
TAILARS
Official Title
A Prospective, Randomized, Open, Parallel Trial of Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome in Rectal Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Anterior Resection Syndrome
Keywords
Low Anterior Resection Syndrome, Transanal irrigation, Rectal cancer, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transanal irrigation
Arm Type
Experimental
Arm Description
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.
Arm Title
Best supportive therapy
Arm Type
Active Comparator
Arm Description
Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.
Intervention Type
Procedure
Intervention Name(s)
Transanal irrigation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Best supportive therapy
Intervention Description
Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Quality of life impairment assessed by Short Form 36 (SF-36)
Description
Quality of life will be assessed by Short Form 36 (SF-36) health questionnaire.
Time Frame
at the time of 6, 12 months since the start of treatment
Title
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
Title
Bowel function impairment
Description
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.
Time Frame
at the time of 6, 12 months since the start of treatment
Title
Fecal continence impairment
Description
Fecal incontinence will be assessed by Wexner incontinence scale.
Time Frame
at the time of 6, 12 months since the start of treatment
Other Pre-specified Outcome Measures:
Title
Anorectal function impairment
Description
Anorectal function will be assessed by anorectal manometry.
Time Frame
at the time of 6 months since the start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiyuan Qin, M.D.
Phone
86-20-38254052
Email
qinqy3@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiyuan Qin, M.D.
Organizational Affiliation
The Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiyuan Qin, M.D.
Phone
86-20-38254052
Email
qinqy3@mail.sysu.edu.cn

12. IPD Sharing Statement

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Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome

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