Tokyo, Sept. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059176) titled 'A Prospective Study on the Safety, Urinary Function Preservation, and Institutional Implementation of the Surgical Image Recognition Support Program' on Sept. 24.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Institute of Science Tokyo
Condition:
Condition - Rectal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - This study is an exploratory prospective investigation targeting patients undergoing robot-assisted rectal resection. It aims to evaluate the safety of real-time use of the surgical visual support AI program EUREKA during surgery, as well as to examine whether the real-time visualization of nerves and the dissection plane may contribute to reducing the incidence of postoperative urinary dysfunction.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - During surgery, AI-analyzed anatomical structures will be displayed on TilePro and made available for reference at any time.
In cases where the operating surgeon does not view the AI analysis results even once throughout the procedure, the case will be excluded from the study analysis.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Patients who meet all of the following criteria will be enrolled in this clinical study:
Age 18 years of age or older at the time of registration.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Patients whose primary tumor site is diagnosed as the rectum based on a comprehensive assessment using preoperative endoscopy and imaging: barium enema and/or abdominopelvic CT.
Patients histopathologically diagnosed with colorectal cancer: adenocarcinoma, mucinous carcinoma, signet-ring cell carcinoma, or adenosquamous carcinoma, by endoscopic biopsy of the primary colorectal lesion.
Preoperative diagnosis of cT1-4 (TNM Classification, 8th edition), excluding direct invasion into other organs (SI or AI according to the Japanese Classification of Colorectal Carcinoma, 9th edition). Clinical N and M stages are not restricted.
Patients scheduled to undergo robot-assisted low anterior resection, intersphincteric resection, or abdominoperineal resection. Cases requiring lateral pelvic lymph node dissection will be excluded.
Written informed consent for participation in this study is obtained from the patient.
Key exclusion criteria - Patients meeting any of the following criteria will be excluded from this study:
Presence of any of the following severe comorbidities:
Active infection requiring systemic therapy.
1.Fever 38.0 degrees Celsius or higher at the time of registration.
2.Uncontrolled diabetes mellitus.
3.Uncontrolled hypertension.
4.Unstable angina (angina newly developed or exacerbated within the past 3 weeks) or history of myocardial infarction within the past 6 months.
5.Uncontrolled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
6.Psychiatric disorders or psychiatric symptoms that interfere with daily life and are judged to make participation in the study difficult.
7.Conversion to open surgery during the operation.
History of pelvic surgery (e.g., rectal resection, total prostatectomy, hysterectomy) or history of pelvic radiotherapy.
Presence of severe preoperative voiding dysfunction.
Ongoing systemic administration (oral or intravenous) of corticosteroids or other immunosuppressive agents.
Female patients who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
Any other condition judged by the principal investigator or sub-investigator to render the patient unsuitable for participation in this study.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 24 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067658
Disclaimer: Curated by HT Syndication.
