NCT05495048

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jul 2023Dec 2028

First Submitted

Initial submission to the registry

August 9, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

5.5 years

First QC Date

August 9, 2022

Last Update Submit

February 22, 2024

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • disease-free survival rate

    disease-free survival rate

    3 years after surgery

Study Arms (2)

NOSES VIIIA

EXPERIMENTAL

totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction

Procedure: NOSES VIIIA

laparoscopic surgery with mini-laparotomy

ACTIVE COMPARATOR

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

Procedure: laparoscopic surgery with mini-laparotomy

Interventions

NOSES VIIIAPROCEDURE

totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction

NOSES VIIIA
laparoscopic surgery with mini-laparotomyPROCEDURE

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

laparoscopic surgery with mini-laparotomy

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • volunteer to participate and the informed consent signed;
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, 200025, China

RECRUITING

Related Publications (1)

  • Yu M, Cai Z, Zhou H, Fingerhut A, He Z, Xue P, Song H, Yang X, Cheng X, Zhang S, Xu X, Zhong H, Abuduaini N, Liu J, Wang X, Feng B. Natural orifice specimen extraction surgery versus small-incision assisted laparoscopic radical right hemicolectomy. Future Oncol. 2023 Dec;19(40):2641-2650. doi: 10.2217/fon-2023-0769. Epub 2023 Dec 18.

    PMID: 38108112DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 10, 2022

Study Start

July 1, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

CN(1)