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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05797064
Enrollment
460
Registered
2023-04-04
Start date
2023-06-01
Completion date
2026-06-01
Last updated
2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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.

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The number of successful operations performed3 yearsAccuracy will be calculated by the number of successful operations performed
The number of successful operations actually completed.3 yearsAccuracy will be calculated by the number of successful operations actually completed.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026