Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study

NCT ID: NCT06350370

Last Updated: 2024-04-05

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

8000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2028-01-01

Brief Summary

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Natural orifice specimen extraction surgery (NOSES) has gained widespread recognition among scholars and has gradually been promoted and popularized around the world. However, the development of NOSES is still in the exploratory stage and there is a lack of strong evidence from evidence-based medicine to support its feasibility and safety, which has greatly affected its clinical application and development. Based on this, at the call of Professor Xishan Wang, the Chinese NOSES Alliance conducted a large retrospective clinical study involving multiple centers. By summarizing the NOSES cases of nearly 100 centers in China, the study aims to clarify the current status of NOSES surgery in China. Additionally, a comprehensive analysis and summary was conducted by combining the basic information of NOSES patients, perioperative data, postoperative pathological data, and follow-up information to further demonstrate the safety and feasibility of NOSES in the treatment of colorectal cancer. This study also provides more real and objective evidence-based medicine support for the promotion and development of NOSES surgery.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NOSES group

Patients with colorectal cancer underwent transanal or transvaginal specimen extraction

Group Type EXPERIMENTAL

Natural orifice specimen extraction

Intervention Type PROCEDURE

We perform laparoscopic colorectal cancer resection, intracorporeal anastomosis and transanal or transvaginal specimen extraction

Interventions

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Natural orifice specimen extraction

We perform laparoscopic colorectal cancer resection, intracorporeal anastomosis and transanal or transvaginal specimen extraction

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Pathological diagnosis of primary malignant tumor in the colon or rectum;
2. The surgery meets the definition in the "Consensus of NOSES Experts in Colorectal Cancer";

Exclusion Criteria

1. Postoperative pathological diagnosis does not belong to primary malignant tumors in the colon or rectum;
2. The surgery does not meet the definition in the "Consensus of NOSES Experts in Colorectal Cancer".
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xishan Wang

Role: CONTACT

+8613552367779

Mingguang Zhang

Role: CONTACT

+8613261967603

Facility Contacts

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Xishan Wang

Role: primary

13261967603

Mingguang Zhang

Role: backup

+8613261967603

Other Identifiers

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NCC3489

Identifier Type: -

Identifier Source: org_study_id

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