Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062529) titled 'Changes in Anorectal Function and Defecatory Dysfunction Before and After Temporary Stoma Closure Following Rectal Cancer Surgery After Neoadjuvant Chemoradiotherapy' on Aug. 10.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - International University of Health and Welfare

Condition: Condition - Rectal cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to prospectively evaluate changes in anorectal function and defecatory dysfunction before and after temporary stoma closure in patients who have undergone rectal cancer surgery with temporary stoma creation following neoadjuvant therapy. Changes in objective anorectal function, bowel function, and quality of life before and after stoma closure will be assessed using anorectal manometry, defecography, and patient-reported questionnaires. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Anorectal manometry, defecography, and questionnaire assessments will be performed before and after temporary stoma closure.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who meet all of the following eligibility criteria will be considered eligible:

1. Patients who have undergone sphincter-preserving rectal resection with temporary ileostomy for rectal cancer following neoadjuvant therapy. 2. Patients scheduled for temporary stoma closure within 3 months to 1 year after rectal resection. 3. Patients confirmed by colonoscopy to have no abnormal findings, such as anastomotic stricture or ulceration. 4. Patients aged 20 years or older at the time of informed consent. 5. Patients who have provided written informed consent voluntarily after receiving an explanation of the study using the written informed consent document. Key exclusion criteria - Patients meeting any of the following criteria will be excluded:

1. Patients who are unable to complete the questionnaires or undergo anorectal function testing due to dementia, psychiatric disorders, or other conditions. 2. Patients who do not wish to undergo temporary stoma closure. 3. Patients with an allergy to barium or wheat flour. 4. Patients whom the principal investigator considers unsuitable for participation in the study for safety reasons. Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 07 Month 22 Day Date of IRB - 2026 Year 07 Month 22 Day Anticipated trial start date - 2026 Year 07 Month 23 Day Last follow-up date - 2027 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071575

Disclaimer: Curated by HT Syndication.