Last updated: June 28, 2023
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Transanal irrigation
Best supportive therapy
Clinical Study ID
NCT04758195
E2021004
Ages 18-75 All Genders
Study Summary
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
ChinaActive - Recruiting
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