Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

Last updated: February 22, 2024
Sponsor: Shanghai Minimally Invasive Surgery Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer

Treatment

NOSES VIIIA

laparoscopic surgery with mini-laparotomy

Clinical Study ID

NCT05495048
NOSES VIIIA Trial
  • Ages 18-75
  • Female

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.

Eligibility Criteria

Inclusion

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 bypreoperative 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

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 studyprotocol.

Study Design

Total Participants: 356
Treatment Group(s): 2
Primary Treatment: NOSES VIIIA
Phase:
Study Start date:
July 01, 2023
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Ruijin Hospital

    Shanghai, 200025
    China

    Active - Recruiting

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