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

April 3, 2023 updated by: Yanxin Luo,MD, Sixth Affiliated Hospital, Sun Yat-sen University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China
        • The Sixth Affiliate Hospital of Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with resectable rectosigmoid cancer.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Other Names:
  • NOSES
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
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.
Other Names:
  • NOSES

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The number of successful operations performed
Time Frame: 3 years
Accuracy will be calculated by the number of successful operations performed
3 years
The number of successful operations actually completed.
Time Frame: 3 years
Accuracy will be calculated by the number of successful operations actually completed.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1010PY(2022)-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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