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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05797064
• Other study ID #: 1010PY(2022)-09
• Status: Not yet recruiting
• Start date: June 1, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 460
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	The Sixth Affiliate Hospital of Sun Yat-Sen University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of successful operations performed	Accuracy will be calculated by the number of successful operations performed	3 years
Primary	The number of successful operations actually completed.	Accuracy will be calculated by the number of successful operations actually completed.	3 years