Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome

Last updated: June 28, 2023
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Transanal irrigation

Best supportive therapy

Clinical Study ID

NCT04758195
E2021004
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 uncontrolledconcomitant disease
  • Cognitive or psychological disorder

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Transanal irrigation
Phase:
Study Start date:
March 01, 2021
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

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