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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Procedure: Natural orifice specimen extraction

Study type: Interventional

Funder types: Other

Identifiers

NCT06350370

NCC3489

Details and patient eligibility

About

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.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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".

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8,000 participants in 1 patient group

NOSES group

Experimental group

Description:

Patients with colorectal cancer underwent transanal or transvaginal specimen extraction

Treatment:

Procedure: Natural orifice specimen extraction