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Clinical Trials/NCT05797064
NCT05797064
Not yet recruiting
Not Applicable

Establishment of a Feasibility Model for Predicting Natural Orifice Specimen Extraction Surgery (NOSES) Based on Machine Learning.

Sixth Affiliated Hospital, Sun Yat-sen University1 site in 1 country460 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Machine Learning
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Enrollment
460
Locations
1
Primary Endpoint
The number of successful operations performed
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
June 1, 2026
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Yanxin Luo,MD

Principal Investigator

Sixth Affiliated Hospital, Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

The number of successful operations performed

Time Frame: 3 years

Accuracy will be calculated by the number of successful operations performed

The number of successful operations actually completed.

Time Frame: 3 years

Accuracy will be calculated by the number of successful operations actually completed.

Study Sites (1)

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