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Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

Sponsor
Shanghai Minimally Invasive Surgery Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05495048
Collaborator
(none)
356
Enrollment
2
Arms
72
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: NOSES VIIIA
  • Procedure: laparoscopic surgery with mini-laparotomy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
356 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2028
Anticipated Study Completion Date :
Dec 31, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: NOSES VIIIA

totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction

Procedure: NOSES VIIIA
totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction
Active Comparator: laparoscopic surgery with mini-laparotomy

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

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

Outcome Measures

Primary Outcome Measures

  1. disease-free survival rate [3 years after surgery]

    disease-free survival rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Minimally Invasive Surgery Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cai Zhenghao, Dr., Shanghai Minimally Invasive Surgery Center
ClinicalTrials.gov Identifier:
NCT05495048
Other Study ID Numbers:
  • NOSES VIIIA Trial
First Posted:
Aug 10, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colonic Neoplasms

Study Results

No Results Posted as of Aug 10, 2022