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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05495048
Other study ID # NOSES VIIIA Trial
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date December 31, 2028

Study information

Verified date February 2024
Source Shanghai Minimally Invasive Surgery Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 356
Est. completion date December 31, 2028
Est. primary completion date December 31, 2028
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
China Ruijin Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Minimally Invasive Surgery Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary disease-free survival rate disease-free survival rate 3 years after surgery
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