Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

February 22, 2024 updated by: Cai Zhenghao, Shanghai Minimally Invasive Surgery Center

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

356

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Minimally Invasive Surgery Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 9, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOSES VIIIA Trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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