Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 8,000
- Locations
- 1
- Primary Endpoint
- Rate of short-term complication
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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".
Arms & Interventions
NOSES group
Patients with colorectal cancer underwent transanal or transvaginal specimen extraction
Intervention: Natural orifice specimen extraction (Procedure)
Outcomes
Primary Outcomes
Rate of short-term complication
Time Frame: 30 days after surgery
Rate of complications occurred within 30 days after surgery
Secondary Outcomes
- 3-year disease free survival(3 year)
- Time to first flatus after surgery(7 days)
- Intraoperative blood loss(7 days)
- Time to first stool after surgery(7 days)
- Operative duration(7 days)
- Length of stay after surgery(7 days)
- 3-year overall survival(3 year)