Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

NCT ID: NCT05495048

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2028-12-31

Brief Summary

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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

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Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NOSES VIIIA

totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction

Group Type EXPERIMENTAL

NOSES VIIIA

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

laparoscopic surgery with mini-laparotomy

Intervention Type PROCEDURE

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

Interventions

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NOSES VIIIA

totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction

Intervention Type PROCEDURE

laparoscopic surgery with mini-laparotomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role lead

Responsible Party

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Cai Zhenghao

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zhenghao Cai

Role: primary

+862164458887

References

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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.

Reference Type DERIVED
PMID: 38108112 (View on PubMed)

Other Identifiers

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NOSES VIIIA Trial

Identifier Type: -

Identifier Source: org_study_id

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