Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

Not Applicable

Recruiting

• Conditions: Colon Cancer
• Interventions: Procedure: NOSES VIIIA; Procedure: laparoscopic surgery with mini-laparotomy

• Registration Number: NCT05495048
• Lead Sponsor: Shanghai Minimally Invasive Surgery Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-10
• Study Start: 2023-07-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 356

Inclusion Criteria

• volunteer to participate and the informed consent signed;
• 18-75 years;
• female who have given birth;
• pathologically confirmed adenocarcinoma/high-grade intraepithelial neoplasia by preoperative colonoscopy and biopsy;
• preoperative CT or MRI indicates that the tumor diameter is no more than 5.0 cm;
• preoperative staging cT1-3NanyM0
• body mass index <30 kg/m2;
• willing to undergo laparoscopic right hemicolectomy

Exclusion Criteria

• contraindications for laparoscopic surgery;
• emergency surgery due to acute intestinal obstruction, perforation or bleeding;
• distant metastasis;
• multiple colorectal cancer;
• has received preoperative chemoradiotherapy;
• with a history of other malignant tumors;
• unwilling to sign the informed consent or receive follow-up according to the study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NOSES VIIIA	NOSES VIIIA	totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction
laparoscopic surgery with mini-laparotomy	laparoscopic surgery with mini-laparotomy	laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy

Primary Outcome Measures

Name	Time	Method
disease-free survival rate	3 years after surgery	disease-free survival rate

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, China