Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection

Status Completed

Clinical Trial Summary

Clinical Trial Description

This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.

Number of patients:

2000 patients, 1000 in each group (with and without ECV). To limit the risk of bias, the investigators will random two teams of 12 endoscopists matched in number, volume of activity and Adenoma Detection Rate (evaluated over a period of the year preceding the study).

Both periods of study will be approximately 3-4 months in length. In order to achieve a perfect balance between the two groups of patients, an inclusion tracking chart will be initiate and will be carefully controlled. Rebalancing will be done for both periods of study to obtain 500 patients per group and per period (= 2000 patients included).

Inclusion of 500 consecutive colonoscopies in each team of investigators, a "colonoscopy with ECV" team, a "colonoscopy without ECV" team then switch and inclusion of 500 new consecutive colonoscopies in each team, ie 2000 colonoscopies in total.

The selection of the team that will begin with ECV (Team A) and the team that will finish with ECV (Team B) will be chosen at random before the start of the study.

A comparison of the two colonoscopy groups with ECV vs without ECV will be made for each team (the investigator will be his own control) and then on the overall population after the end of the trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03344055
Study type	Interventional
Source	Société Française d'Endoscopie Digestive
Contact
Status	Completed
Phase	N/A
Start date	November 15, 2017
Completion date	November 15, 2018

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Withdrawn	`NCT05754255` - Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory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
Completed	`NCT01964417` - The Comparative Study Between Bowel Preparation Method	Phase 3
Terminated	`NCT01978509` - The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies	N/A
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	`NCT00209573` - A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy	Phase 3
Completed	`NCT00427089` - Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening	Phase 3
Completed	`NCT05823350` - The Effect of Abdominal Massage on Pain and Distention After Colonoscopy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate — Cuff-Bercy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms