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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06350370
• Other study ID #: NCC3489
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 1, 2028

Study information

• Verified date: May 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Xishan Wang
• Phone: +8613552367779
• Email: wxshan_cams[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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".

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Natural orifice specimen extraction
We perform laparoscopic colorectal cancer resection, intracorporeal anastomosis and transanal or transvaginal specimen extraction

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of short-term complication	Rate of complications occurred within 30 days after surgery	30 days after surgery
Secondary	Operative duration	Total time of the operation	7 days
Secondary	Intraoperative blood loss	Estimated blood loss during the surgery	7 days
Secondary	Time to first flatus after surgery	Time to first flatus after surgery	7 days
Secondary	Time to first stool after surgery	Time to first stool after surgery	7 days
Secondary	Length of stay after surgery	Length of stay after surgery	7 days
Secondary	3-year disease free survival	3-year disease free survival	3 year
Secondary	3-year overall survival	3-year overall survival	3 year