Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

Study Overview
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Brief Summary
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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
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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)

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: NOSES VIIIA
* Procedure: laparoscopic surgery with mini-laparotomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NOSES VIIIA<br>totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction | Procedure: NOSES VIIIA<br>* totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction<br>|
| Active Comparator: laparoscopic surgery with mini-laparotomy<br>laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy | Procedure: laparoscopic surgery with mini-laparotomy<br>* laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival rate | disease-free survival rate | 3 years after surgery |