Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

Colon Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495048
• Other study ID #: NOSES VIIIA Trial
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

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