Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

ConditionColon Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShanghai Minimally Invasive Surgery Center

About this 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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

contraindications for laparoscopic surgery;

emergency surgery due to acute intestinal obstruction, perforation or bleeding;

distant metastasis;

multiple colorectal cancer;

Trial design

Treatments tested in this trial

  • NOSES VIIIA
  • laparoscopic surgery with mini-laparotomy

Treatment groups

356 Participants
are divided into 2 treatment groups