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Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05495048
Recruitment Status : Recruiting
First Posted : August 10, 2022
Last Update Posted : February 26, 2024
Sponsor:
Information provided by (Responsible Party):
Cai Zhenghao, Shanghai Minimally Invasive Surgery Center

Tracking Information
First Submitted Date  ICMJE August 9, 2022
First Posted Date  ICMJE August 10, 2022
Last Update Posted Date February 26, 2024
Actual Study Start Date  ICMJE July 1, 2023
Estimated Primary Completion Date December 31, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2022)		 disease-free survival rate [ Time Frame: 3 years after surgery ]
disease-free survival rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • Procedure: NOSES VIIIA
    totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction
  • Procedure: laparoscopic surgery with mini-laparotomy
    laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy
Study Arms  ICMJE
  • Experimental: NOSES VIIIA
    totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction
    Intervention: Procedure: NOSES VIIIA
  • Active Comparator: laparoscopic surgery with mini-laparotomy
    laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy
    Intervention: Procedure: laparoscopic surgery with mini-laparotomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 9, 2022)		 356
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2028
Estimated Primary Completion Date December 31, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05495048
Other Study ID Numbers  ICMJE NOSES VIIIA Trial
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cai Zhenghao, Shanghai Minimally Invasive Surgery Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Shanghai Minimally Invasive Surgery Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Minimally Invasive Surgery Center
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP