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

NCT ID: NCT05797064

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 460 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-06-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Natural Orifice Specimen Extraction Surgery

Intervention Type: 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.

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.

Natural Orifice Specimen Extraction Surgery

Intervention Type: 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.

Interventions

Natural Orifice Specimen Extraction Surgery

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.

Intervention Type: PROCEDURE

Other Intervention Names

NOSES

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanxin Luo,MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Countries

China

Facility Contacts

Yanxin Luo, PhD,MD

Role: primary

luoyx25@mail.sysu.edu.cn

86-13826190263

Yaoyi Huang, BS

Role: backup

huangyy355@mail2.sysu.edu.cn

86-15986423743

Other Identifiers

1010PY(2022)-09

Identifier Type: -

Identifier Source: org_study_id