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Trial Title:
Establishment of a Feasibility Model for NOSE Surgery Based on Machine Learning
NCT ID:
NCT05797064
Condition:
Machine Learning
Surgery
Rectosigmoid Cancer
Natural Orifice Specimen Extraction Surgery
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Natural Orifice Specimen Extraction Surgery
Description:
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.
Arm group label:
Training set
Arm group label:
test set
Other name:
NOSES
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.
Criteria for eligibility:
Study pop:
Patients diagnosed with resectable rectosigmoid cancer.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Sixth Affiliate Hospital of Sun Yat-Sen University
Address:
City:
GuangZhou
Country:
China
Contact:
Last name:
Yanxin Luo, PhD,MD
Phone:
86-13826190263
Email:
luoyx25@mail.sysu.edu.cn
Contact backup:
Last name:
Yaoyi Huang, BS
Phone:
86-15986423743
Email:
huangyy355@mail2.sysu.edu.cn
Start date:
June 1, 2023
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Sixth Affiliated Hospital, Sun Yat-sen University
Agency class:
Other
Source:
Sixth Affiliated Hospital, Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05797064
