Clinical Trial

Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

Recruiting
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Summary
It is controversial that totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction (NOSES VIIIA) can provide non-inferior oncological outcomes compared to conventional laparoscopic surgery with mini-laparotomy in the treatment of right colon cancer. We aim to carry out a multicenter, open-lable, parallel, non-inferiority, phase III, randomized controlled clinical trial, which enrolls 356 female patients with cT1-3NxM0 right colon adenocarcinoma. They are randomly assigned to the experimental group (NOSES VIIIA) or the control group (laparoscopic surgery with mini-laparotomy) in a 1:1 ratio. Perioperative indicators, pathological results, quality of life and cosmetic evaluation will be compared between the two groups. Then, a three-year follow-up of these patients will provide evidence for long-term oncological outcomes of NOSES VIIIA.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-08-09.
Status change: Not Yet Recruiting → Recruiting 2024-02-22
Trial Details
NCT Number NCT05495048
Lead Sponsor Shanghai Minimally Invasive Surgery Center
Conditions Colon Cancer
Enrollment 356 participants
Start Date 2023-07-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-02-26