Clinical trial NCT03117114: Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum
Official title: Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Polyp
Keywords: colonoscopy
polyp
resection
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Polyp resection
timeFrame: up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)]
Secondary outcomes:
measure: Polyp detection
timeFrame: up to day 1
measure: Cecal intubation time
timeFrame: up to day 1
measure: Ileum intubation time
timeFrame: up to day 1
measure: Total procedure duration
timeFrame: up to day 1
measure: Complications
timeFrame: up to day 1
measure: Propofol dosage
timeFrame: up to day 1
measure: Patient satisfaction
timeFrame: up to day 1
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar der TU München
state: Bavaria
Study officials:
affiliation: Technical University of Munich
name: Peter Klare, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Figura G, Hasenohrl M, Haller B, Poszler A, Ulrich J, Brown H, Abdelhafez M, Schmid RM, von Delius S, Klare P. Endocuff vision-assisted vs. standard polyp resection in the colorectum (the EVASTA study): a prospective randomized study. Endoscopy. 2020 Jan;52(1):45-51. doi: 10.1055/a-1018-1870. Epub 2019 Oct 15.