Colon Polyp
Conditions
Keywords
colonoscopy, polyp, resection
Brief summary
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.
Interventions
DEVICEEndocuff Vision assisted polypectomy
EVD mounted to the tip of the endoscope, therefore EVD assisted polypectomy
OTHERStandard polypectomy
Absence of an EVD, standard polypectomy
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polyp resection | up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)] | Time of polyp resection will be measured using a stopwatch. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cecal intubation time | up to day 1 | Time span until cecum is reached with the tip of the scope |
| Ileum intubation time | up to day 1 | Time span until ileum is reached |
| Total procedure duration | up to day 1 | Total procedure duration |
| Polyp detection | up to day 1 | a maximum of one day is expected for colonoscopy procedures |
| Propofol dosage | up to day 1 | Amount of propofol used for colonoscopy |
| Patient satisfaction | up to day 1 | Measured on a 10 point numeric scale |
| Complications | up to day 1 | Bleeding, perforation and other complications |
Countries
Germany
Outcome results
None listed