Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

Shanghai Minimally Invasive Surgery Center

Status

Enrolling

Conditions

Colon Cancer

Treatments

Procedure: laparoscopic surgery with mini-laparotomy

Procedure: NOSES VIIIA

Study type

Interventional

Funder types

Other

Identifiers

NCT05495048

NOSES VIIIA Trial

Details and patient eligibility

About

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.

Enrollment

356 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.