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Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

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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

Study Description
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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
Colon Cancer Procedure: NOSES VIIIA Procedure: laparoscopic surgery with mini-laparotomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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)
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028
Arms and Interventions
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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
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Primary Outcome Measures :
  1. disease-free survival rate [ Time Frame: 3 years after surgery ]
    disease-free survival rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05495048


Locations
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China
Ruijin Hospital Recruiting
Shanghai, China, 200025
Contact: Zhenghao Cai    +862164458887    c3z2h1@alumni.sjtu.edu.cn   
Sponsors and Collaborators
Shanghai Minimally Invasive Surgery Center
More Information
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Responsible Party: Cai Zhenghao, Dr., Shanghai Minimally Invasive Surgery Center
ClinicalTrials.gov Identifier: NCT05495048    
Other Study ID Numbers: NOSES VIIIA Trial
First Posted: August 10, 2022    Key Record Dates
Last Update Posted: February 26, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases