Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum

Study Overview
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Brief Summary
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Adenomas are premalignant polyps of the colon that should be resected endoscopically. Complete resection of adenomatous polyps is the major task of colonoscopy. In some cases polyp may be poorly accessible making endoscopic resection difficult. Polypectomy may be conducted using the so-called piece meal technique in these cases. However, leaving polyp residual polyps in the colon bears the risk of malignant degeneration as colorectal cancer may arise form adenomatous remnants. In case of difficult polyp locations endoscopic resection may also be time consuming. On the other hand endoscopists are facing an increased time pressure due to rising numbers of procedures during the last decades. The Endocuff Vision device (EVD) is a cap that can be mounted to the tip of a standard endoscope. The EVD has small flexible branches on its outside. The branches turn out during withdrawal. By that the branches are getting in contact with colonic wall. This mechanism leads to a more stabilized position of the colonoscope in the bowel. It is hypothesized that resection circumstances may be improved by using an EVD. In addition, stabilizing the scope during resection may result in a reduced time effort. Until now no controlled trials exist investigating the effect of EVD on the time effect during polyp resection. Therefore a randomized controlled trial needed comparing standard polypectomy versus polypectomy using the EVD during routine colonoscopy procedures.

Official Title
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Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum

Conditions
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Colon Polyp

Intervention / Treatment
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* Device: Endocuff Vision assisted polypectomy
* Other: Standard polypectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication for colonoscopy age ≥ 40 years Exclusion Criteria: American Society of Anesthesiologists class IV or higher pregnant women indication for colonoscopy: inflammatory bowel disease indication for colonoscopy: polyposis syndrome indication for colonoscopy: emergency colonoscopy e.g. acute bleeding contraindication for polyp resection e.g. patients on warfarin Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Arm<br>Standard colonoscopy without mounted Endocuff Vision device. Therefore standard polypectomy in case of polyp resection. | Other: Standard polypectomy<br>* Absence of an EVD, standard polypectomy<br>|
| Active Comparator: Endocuff Vision Arm<br>Endocuff Vision device mounted to the endoscope prior to the beginning of the procedure. Therefore EVD assisted polypectomy in case of polyp resection. | Device: Endocuff Vision assisted polypectomy<br>* EVD mounted to the tip of the endoscope, therefore EVD assisted polypectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp resection | Time of polyp resection will be measured using a stopwatch. | up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection | a maximum of one day is expected for colonoscopy procedures | up to day 1 | 
| Cecal intubation time | Time span until cecum is reached with the tip of the scope | up to day 1 | 
| Ileum intubation time | Time span until ileum is reached | up to day 1 | 
| Total procedure duration | Total procedure duration | up to day 1 | 
| Complications | Bleeding, perforation and other complications | up to day 1 | 
| Propofol dosage | Amount of propofol used for colonoscopy | up to day 1 | 
| Patient satisfaction | Measured on a 10 point numeric scale | up to day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, polyp, resection