Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome

NCT04758195 | Unknown

• 1 other identifier: E2021004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Anterior Resection Syndrome

Keywords

Low Anterior Resection Syndrome; Transanal irrigation; Rectal cancer; Prevention

Outcome Measures

Primary Outcomes (1)

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

  at the time of 6 months since the start of treatment

Secondary Outcomes (4)

• Quality of life impairment assessed by Short Form 36 (SF-36)

  at the time of 6, 12 months since the start of treatment

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

  at the time of 1, 3, 12 months since the start of treatment

• Bowel function impairment

  at the time of 6, 12 months since the start of treatment

• Fecal continence impairment

  at the time of 6, 12 months since the start of treatment

Other Outcomes (1)

• Anorectal function impairment

  at the time of 6 months since the start of treatment

Study Arms (2)

Transanal irrigation

EXPERIMENTAL

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

Best supportive therapy

ACTIVE COMPARATOR

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

Other: Best supportive therapy

Interventions

Transanal irrigation PROCEDURE

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.

Transanal irrigation

Best supportive therapy OTHER

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

Best supportive therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Qiyuan Qin, M.D.

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiyuan Qin, M.D.

CONTACT

86-20-38254052; qinqy3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 17, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: June 29, 2023

Record last verified: 2023-06

Locations

CN (1)