Clinical Trials Logo
  1. Home
  2. Colonoscopy
  3. NCT05448300

Adenoma Detection Rate in Water and Air Colonoscopy Using Computer-aided System

Colonoscopy Clinical Trial

Official title:
Adenoma Detection Using Real-Time Computer-Aided Colon Polyp Detection System to Compare Water Exchange and Air Insufflation - A Randomized Controlled Trial

Clinical Trial Summary

Water exchange (WE) is an effective insertion method to minimize insertion discomfort and maximize ADR. It is characterized by infusing water to guide insertion in an airless lumen with suctioning of infused water during insertion and almost complete removal of the infused water when cecal intubation is achieved. A modified Delphi review reported water exchange showed the highest overall ADR, ADR in screening cases, and in the right side of the colon compared with water immersion and air (or CO2) insufflation. One of the plausible mechanisms of improving ADR by water exchange is salvage cleaning during insertion, which might help artificial intelligence by removing the interference of fecal debris and bubbles. However, no RCT has been performed to evaluate the effect of CADe on WE colonoscopy. Therefore, investigators will conduct a RCT comparing the ADR of CADe assisted colonoscopy inserted with either WE or insufflation. Our hypothesis will be that CADe assisted WE colonoscopy achieves higher ADR than CADe assisted air insufflation colonoscopy.

Clinical Trial Description

The primary end point will be ADR, defined as the proportion of patients with at least one adenoma. Serrated lesions will not be counted as part of ADR. Secondary outcomes were FP rate, adenomas per colonoscopy (APC), polyp detection rate, polyps per colonoscopy, SL detection rate, cecal intubation rate, withdrawal time. Missed polyp will be defined as a polyp recognized by endoscopist, but is not detected by CADe system at an interval of 2 seconds. The detected polyps will be classified in sizes, morphology (polypoid or nonpolypoid). Investigators also record the detection of every polyp by the endoscopist or the CADe system in time priority. If a polyp is detected by performing endoscopist at the same time as the CADe system, the credit will go to the endoscopist. The colonoscopy procedure will be recorded as CADe over-laid videos and be reviewed for FP characteristics, numbers and appearance time afterward. The withdrawal time will be divided into inspection time, cleaning time and polypectomy time. Boston Bowel Preparation Scale score and the amount of water infused and aspirated will also be recorded. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05448300
Study type Interventional
Source Dalin Tzu Chi General Hospital
Contact Chia Pei Tang, MD
Phone 0921128335
Email franktg@hotmail.com
Status Recruiting
Phase N/A
Start date May 16, 2022
Completion date May 15, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT04101097 - Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy
Completed NCT03247595 - Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy N/A
Completed NCT04214301 - An Open-Label Preference Evaluation of BLI800 Phase 4
Withdrawn NCT05754255 - Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center N/A
Recruiting NCT02484105 - Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction Phase 4
Active, not recruiting NCT02264249 - Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation N/A
Terminated NCT01978509 - The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies N/A
Completed NCT01964417 - The Comparative Study Between Bowel Preparation Method Phase 3
Recruiting NCT01685970 - Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy Phase 3
Completed NCT01518790 - Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children N/A
Recruiting NCT00748293 - Achievement of Better Examinee Compliance on Colon Cleansing Using Commercialized Low-Residue Diet N/A
Completed NCT00779649 - MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial Phase 4
Completed NCT00671177 - Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique N/A
Completed NCT00380497 - Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children Phase 4
Recruiting NCT00160823 - Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients Phase 3
Completed NCT00390598 - PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy Phase 2/Phase 3
Completed NCT00314418 - Patient Position and Impact on Colonoscopy Time N/A
Completed NCT00427089 - Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening Phase 3
Completed NCT00209573 - A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy Phase 3
Completed NCT05823350 - The Effect of Abdominal Massage on Pain and Distention After Colonoscopy N/A