Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

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.

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.