Adenoma
Conditions
Brief summary
Colonoscopy is a key technique in the detection and diagnosis of lower gastrointestinal diseases. High quality endoscopy results in better disease outcomes. However, the operant level of different endoscopists is significantly different.This study aims to construct a real-time quality monitoring system based on computer vision, named Endo.Angel, which is used to monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.
Detailed description
This study aims to construct a real-time quality monitoring system based on computer vision, named Endo.Angel, which is used to monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.Criteria for inclusion and exclusion are determined prior to endoscopic examination. Candidates who meet all inclusion criteria as well as do not meet all exclusion criteria are bring into the study. Participants randomized before the examination, they are divided into the exposed group assisted by Endo.Angel or the non-exposed group without Endo.Angel. Followup are conducted after the examination.Study will be finished when all followup is done,and the examination result collected from participants will send to an independent review data analysis group.
Interventions
DIAGNOSTIC_TESTColonoscopy with assistance of Endo.Angel
Patients in exposed group will receive colonoscopy with assistance of Endo.Angel,a real-time quality monitoring system based on computer vision,which is used to monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.
DIAGNOSTIC_TESTColonoscopy without assistance of Endo.Angel
Patients in non-exposed group will receive colonoscopy without assistance of Endo.Angel.
Sponsors
Renmin Hospital of Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomization results were kept confidential in the general case, and information on the use of EndoAngel was not reflected in the hospital history and documents obtained by other subjects. During the examination and after the examination, researchers should take care to avoid talking to the subjects about random content and avoid unnecessary blindness. The evaluator was blinded, and neither the data analysis team nor the pathologist could obtain random result information from the medical history data, regardless of whether the subject used EndoAngel or not.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Men or women over the age of 18 years old; 2. Ability to read, understand and sign informed consent; 3. The investigator believes that the subject understands the flow of the clinical study and is willing and able to complete all the research procedures and follow-up visits in conjunction with the research procedure.
Exclusion criteria
1. Colonoscopy patients with absolute contraindications; 2. patients with biopsy contraindications; 3. inflammatory bowel disease, colorectal cancer, history of colorectal surgery; 4. women during pregnancy or lactation; 5. Patients with multiple polyposis syndrome; 6. Patients with known or suspected intestinal obstruction or perforation 7. Previously failed colonoscopy; 8. The investigator believes that the subject is not suitable for high-risk disease or other special conditions in clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | 3 months. | The numerator is the number of cases of adenoma detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polyp Detection Rate | 3 months. | The numerator is the number of patients with polyps detected by colonoscopy, and the denominator is the total number of patients receiving colonoscopy. |
| The mean number of adenomas per procedure | 3 months. | The numerator is the total number of adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy |
| The mean number of polyps per procedure | 3 months. | The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy. |
| The mean number of large, small and minimal polyps per procedure | 3 months. | The numerator was the number of large (≥10 mm), small (4-9 mm), and minimal (≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy |
| Detection rate of large, small and minimal adenomas | 3 months. | The numerator was the number of patients with large (≥10 mm), small (4-9 mm), and minimal(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy |
| Detection rate of large, small and minimal polyps | 3 months. | The numerator was the number of patients with large (≥10 mm), small (4-9 mm), and minimal(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy |
Countries
China
Contacts
Primary ContactHonggang Yu, MD
Outcome results
None listed