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A Phase II Study to Evaluate the Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Treatment of Patients With Colon Cancer
This study aims to evaluate the safety and efficacy of radical colectomy with hybrid transvaginal natural orifice transluminal endoscopic surgery (hvNOTES). This is a prospective, single-arm, multicenter, uncontrolled, open-label phase II study in 55 eligible subjects with resectable colon cancer. After informed consent, patients will be sent to have hvNOTES radical colectomy by surgeons with good experience in laparoscopic colorectal surgery. Patients' demographic, operative detail and postoperative outcomes including conversion to open surgery, operating time, blood loss, pain score, resumption of gastrointestinal function, postoperative complications, length of hospital stay, sexual function, quality of recovery, recurrence rate, recurrence patterns, relapse-free survival, and overall survival will be recorded prospectively. The results of the patients will be assessed to validate safety, functional outcomes or oncologic outcomes of hvNOTES colectomy.
Age
18 - 80 years
Sex
FEMALE
Healthy Volunteers
No
Beijing Friendship Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Daping Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Start Date
December 20, 2019
Primary Completion Date
November 30, 2024
Completion Date
November 30, 2025
Last Updated
August 3, 2023
55
ESTIMATED participants
hvNOTES radical colectomy
PROCEDURE
Lead Sponsor
Renmin Hospital of Wuhan University
NCT04704661
NCT04674267
Data Source & Attribution
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