Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062542) titled 'A study on the usability of a new articulating laparoscopic instrument (ArtiSential) in rectal cancer surgery' 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 - National Cancer Center

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

Objective: Narrative objectives1 - To evaluate surgeon-reported usability of the ArtiSential monopolar electrode used in the perineal phase of transanal total mesorectal excision (TaTME). Basic objectives2 - Others

Intervention: Interventions/Control_1 - Transanal total mesorectal excision (TaTME) using the ArtiSential monopolar electrode (certification number: 302AFBZI00049000) during the perineal phase; all other procedures follow routine clinical practice. After each surgery, the operating surgeon completes a usability questionnaire. Follow-up: 1 month after surgery.

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 criteria: (1) Rectal tumor (any histology) with the lower tumor border located within 10 cm from the anal verge, scheduled to undergo TaTME (2) Clinical T1-3, N1-2, M0 (3) Age 20 years or older at enrollment (4) Written informed consent obtained from the patient *High-risk T1 cases requiring additional surgical resection after prior EMR/ESD are also eligible. (Surgeon inclusion criterion: board certification under the Endoscopic Surgical Skill Qualification System of the Japan Society for Endoscopic Surgery) Key exclusion criteria - Patients who meet any of the following criteria are excluded: (1) Emergency surgery (2) Cases requiring lateral pelvic lymph node dissection (3) Cases requiring combined resection of other organs (4) Psychiatric disease or symptoms making participation inappropriate (5) Inability to provide written informed consent (6) Judged inappropriate for the study by the physician (Surgeon exclusion criteria: surgeons who do not consent, or judged inappropriate by the investigators) Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 11 Month 04 Day Date of IRB - 2025 Year 11 Month 11 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2026 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071589

Disclaimer: Curated by HT Syndication.