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Recruiting NCT06350370

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

No phase Interventional Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Natural orifice specimen extraction.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • Rate of short-term complication [Time frame: 30 days after surgery]
Secondary outcome measures (7)
  • Operative duration [Time frame: 7 days]
  • Intraoperative blood loss [Time frame: 7 days]
  • Time to first flatus after surgery [Time frame: 7 days]
  • Time to first stool after surgery [Time frame: 7 days]
  • Length of stay after surgery [Time frame: 7 days]
  • 3-year disease free survival [Time frame: 3 year]
  • 3-year overall survival [Time frame: 3 year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT06350370 · NCC3489

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗