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)

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05495048

Enrollment

356

Registered

2022-08-10

Start date

2023-07-01

Completion date

2028-12-31

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Brief 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.

Interventions

PROCEDURENOSES VIIIA

totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction

PROCEDURElaparoscopic surgery with mini-laparotomy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 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.

Design outcomes

Primary

Measure	Time frame	Description
disease-free survival rate	3 years after surgery	disease-free survival rate

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026