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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06350370
Enrollment
8000
Registered
2024-04-05
Start date
2019-01-01
Completion date
2028-01-01
Last updated
2024-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Colorectal cancer, Natural orifice specimen extraction surgery, Minimally invasive surgery

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.

Interventions

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

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of short-term complication30 days after surgeryRate of complications occurred within 30 days after surgery

Secondary

MeasureTime frameDescription
Intraoperative blood loss7 daysEstimated blood loss during the surgery
Time to first flatus after surgery7 daysTime to first flatus after surgery
Time to first stool after surgery7 daysTime to first stool after surgery
Operative duration7 daysTotal time of the operation
3-year disease free survival3 year3-year disease free survival
3-year overall survival3 year3-year overall survival
Length of stay after surgery7 daysLength of stay after surgery

Countries

China

Contacts

Primary ContactXishan Wang
wxshan_cams@163.com+8613552367779
Backup ContactMingguang Zhang
zmgslimshady@163.com+8613261967603

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026