Establishment of a Feasibility Model for NOSE Surgery Based on Machine Learning

Not yet recruiting

• Conditions: Machine Learning; Rectosigmoid Cancer; Surgery; Natural Orifice Specimen Extraction Surgery

• Registration Number: NCT05797064
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

The goal of this observational study is to test in patients with resectable rectosigmoid cancers. The main question it aims to answer is establishment of a feasibility model for predicting natural orifice specimen extraction surgery (NOSES) based on machine learning.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-21
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Study First Posted: 2023-04-04
• Last Update Posted: 2023-04-04
• Study Start: 2023-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

1. Patients diagnosed with colorectal cancer or large adenoma who are suitable for laparoscopic colorectal surgery;
2. Tumor staging ≤ T3 without invasion of surrounding organs;
3. No abdominal seeding or distant organ metastasis;
4. Clear and complete imaging data (CT, pelvic MRI) that can be processed by a computer;
5. Feasible evaluation and determination for obtaining specimens through the rectal channel during preoperative and intraoperative assessments.

Exclusion Criteria

1. Contraindications for laparoscopic colorectal surgery;
2. Tumor staging is T4, or there are cancer nodules;
3. Presence of metastasis or distant organ metastasis;
4. Incomplete imaging data;
5. Preoperative intestinal obstruction;
6. Tumor or specimen diameter larger than the transverse diameter of the pelvic outlet;
7. Previous rectal radiotherapy;
8. Unsuitable evaluation and determination for obtaining specimens through the rectal channel during preoperative and intraoperative assessments.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of successful operations performed	3 years	Accuracy will be calculated by the number of successful operations performed
The number of successful operations actually completed.	3 years	Accuracy will be calculated by the number of successful operations actually completed.

Trial Locations

Locations (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University; 🇨🇳 GuangZhou, Guangdong, China