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RECRUITING
NCT05495048
NA

Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

Sponsor: Shanghai Minimally Invasive Surgery Center

View on ClinicalTrials.gov

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

PROCEDURE

NOSES VIIIA

totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction

PROCEDURE

laparoscopic surgery with mini-laparotomy

laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy

Locations (1)

Ruijin Hospital

Shanghai, China