Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

NCT05495048 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Minimally Invasive Surgery Center

Phase

Not applicable

Started

2023-07-01

Last updated

2024-02-26

Condition(s) studied

Colon Cancer

Investigational drug(s) / intervention(s)

NOSES VIIIAlaparoscopic surgery with mini-laparotomy

NOSES VIIIA: totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction

laparoscopic surgery with mini-laparotomy: laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy

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

Sex

FEMALE

Min age

18 Years

Max age

75 Years

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.

Primary outcome measure(s)

disease-free survival rate — 3 years after surgery
disease-free survival rate

Trial sites (1)

Facility	City	Region	Status
Ruijin Hospital	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05495048 on ClinicalTrials.gov ↗ ← All trials in China