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

NCT05797064 | Not Yet Recruiting DMC

• 1 other identifier: 1010PY(2022)-09
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Machine Learning; Surgery; Rectosigmoid Cancer; Natural Orifice Specimen Extraction Surgery

Outcome Measures

Primary Outcomes (2)

• The number of successful operations performed

  Accuracy will be calculated by the number of successful operations performed

  3 years

• The number of successful operations actually completed.

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

  3 years

Study Arms (2)

Training set

The training set is a dataset used to train the model, which includes randomly enrolled patients with colon and rectal cancer. The inputs include data such as gender, age, height, weight, BMI, tumor stage, tumor pathology type, and the output information is whether NOSES surgery was successful or not. During training, the model learns from this dataset to make predictions on whether new patients with colon and rectal cancer can undergo NOSES surgery successfully.

Procedure: Natural Orifice Specimen Extraction Surgery

test set

The test set is a dataset used to evaluate the performance of a trained machine learning model. It includes another randomly enrolled group of patients with colon and rectal cancer, as well as their clinical and pathological data and surgical outcomes. The outputs are not used during training, but are used to test the trained model to evaluate its predictive ability on unknown data. The purpose is to evaluate the model's generalization ability, that is, its performance on new and unknown data.

Procedure: Natural Orifice Specimen Extraction Surgery

Interventions

Natural Orifice Specimen Extraction Surgery PROCEDURE

Natural Orifice Specimen Extraction Surgery (NOSES) is a minimally invasive surgical technique that aims to reduce the size and number of incisions required during certain surgeries. In NOSES, the surgical specimen (such as a diseased organ or tumor) is removed from the body through a natural orifice (such as the mouth, anus, or vagina), rather than through an incision in the abdominal wall. In this trial, we will extract surgical specimens from the rectum to reduce trauma to the abdominal wall.

Also known as: NOSES

Training set; test set

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with resectable rectosigmoid cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 4, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

CN (1)