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Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

NCT05495048 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2024-02-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shanghai Minimally Invasive Surgery Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05495048 on ClinicalTrials.gov