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Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy
Sponsor: Shanghai Minimally Invasive Surgery Center
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.
Official title: Transvaginal Natural Orifice Specimen Extraction Surgery Versus Conventional Laparoscopic Surgery With Mini-laparotomy in Right Hemicolectomy for Colon Cancer: a Randomised, Controlled, Phase 3, Non-inferiority Trial (NOSES VIIIA Trial)
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
356
Start Date
2023-07-01
Completion Date
2028-12-31
Last Updated
2024-02-26
Healthy Volunteers
No
Conditions
Interventions
NOSES VIIIA
totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction
laparoscopic surgery with mini-laparotomy
laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy
Locations (1)
Ruijin Hospital
Shanghai, China