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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Procedure: Natural orifice specimen extraction

• Registration Number: NCT06350370
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

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

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2023-01-01
• Status Verified: 2023-05
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-01
• Last Update Submitted: 2024-04-01
• Study First Posted: 2024-04-05
• Last Update Posted: 2024-04-05
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8000

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".

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NOSES group	Natural orifice specimen extraction	Patients with colorectal cancer underwent transanal or transvaginal specimen extraction

Primary Outcome Measures

Name	Time	Method
Rate of short-term complication	30 days after surgery	Rate of complications occurred within 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Intraoperative blood loss	7 days	Estimated blood loss during the surgery
Time to first stool after surgery	7 days	Time to first stool after surgery
Time to first flatus after surgery	7 days	Time to first flatus after surgery
Operative duration	7 days	Total time of the operation
Length of stay after surgery	7 days	Length of stay after surgery
3-year disease free survival	3 year	3-year disease free survival
3-year overall survival	3 year	3-year overall survival

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China