NCT05495048

Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 356 (estimated)
• Sponsor: Shanghai Minimally Invasive Surgery Center · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2022-08-10
• Last updated: 2024-02-26

Locations

1 site across 1 country: China