Comparison of Two Devices During Colonoscopy

Adenomatous Polyps Clinical Trial

— COLONAUX  

Official title:

Endocuff vs Transparent Cap To Increase Adenoma Detection Rate During Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197987
• Other study ID #: ADR-1
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: November 2018
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy. In this study we compare two devices: Endocuff (TM) and cap that can increase the adenoma detection rate during colonoscopy.

Description:

Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy and a high adenoma detection rate is associated with a lower incidence of interval cancers. Several technological advancements have been explored to improve adenoma detection rate. Endocuff Vision™ has been shown to improve adenoma detection rate in several studies. Cap-assisted colonoscopy is a technique that allow improved visualization of the colonic folds by flattening the fold within the viewing field. However, studies have reported mixed results on adenoma detection in cap-assisted colonoscopy.

This is a prospective, single-centre, randomized controlled trial comparing the adenoma detection rate in patients undergoing Endocuff Vision™-assisted colonoscopy versus cap-assisted colonoscopy. Patients are randomized according to bowel cancer screening status to receive Endocuff Vision™-assisted colonoscopy or cap colonoscopy on the day of procedure. Baseline data, colonoscopy, and polyp data including histology are collected. Patients are followed up at 30 days for complications. This study will take place in an University Hospital in Spain. A maximum of 9 expert colonoscopists will recruit a total of 712 patients.

This is the first trial to evaluate the adenoma detection rate of Endocuff Vision™ vs cap colonoscopy in all screening, surveillance, and diagnostic patient groups. This study will guide clinicians to decide what device to use to increase adenoma detection rate in routine colonoscopy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 710
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients who are attending for screening, surveillance or diagnostic colonoscopy.

Exclusion Criteria:

• patients with absolute contraindications to colonoscopy;

• patients with established or suspicion of large bowel obstruction or pseudo-obstruction;

• patients with known colonic strictures;

• patients with a known severe diverticular segment (that is likely to impede colonoscope passage);

• patients with active or known colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis);

• patients lacking capacity to give informed consent;

• patients on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure;

• patients who are attending for a therapeutic procedure or assessment of a known lesion, or submitted for rectoscopy or rectosigmoidoscopy;

• examination performed by a non-expert colonoscopist;

• pregnancy.

Related Conditions & MeSH terms

• Adenomatous Polyps

Intervention

Device:
• Endocuff
Endocuff-assisted colonoscopy
• cap
Cap-assisted colonoscopy

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Elche	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

References & Publications (12)

Biecker E, Floer M, Heinecke A, Ströbel P, Böhme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166. — View Citation

de Wijkerslooth TR, Stoop EM, Bossuyt PM, Mathus-Vliegen EM, Dees J, Tytgat KM, van Leerdam ME, Fockens P, Kuipers EJ, Dekker E. Adenoma detection with cap-assisted colonoscopy versus regular colonoscopy: a randomised controlled trial. Gut. 2012 Oct;61(10):1426-34. doi: 10.1136/gutjnl-2011-301327. Epub 2011 Dec 20. — View Citation

Floer M, Biecker E, Fitzlaff R, Röming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Ströbel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014. — View Citation

Frieling T, Neuhaus F, Kuhlbusch-Zicklam R, Heise J, Kreysel C, Hülsdonk A, Blank M, Czypull M. Prospective and randomized study to evaluate the clinical impact of cap assisted colonoscopy (CAC). Z Gastroenterol. 2013 Dec;51(12):1383-8. doi: 10.1055/s-0033-1335637. Epub 2013 Dec 11. — View Citation

Hewett DG, Rex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc. 2010 Oct;72(4):775-81. doi: 10.1016/j.gie.2010.04.030. Epub 2010 Jun 25. — View Citation

Horiuchi A, Nakayama Y, Kato N, Ichise Y, Kajiyama M, Tanaka N. Hood-assisted colonoscopy is more effective in detection of colorectal adenomas than narrow-band imaging. Clin Gastroenterol Hepatol. 2010 Apr;8(4):379-83. doi: 10.1016/j.cgh.2009.08.018. Epub 2009 Aug 26. — View Citation

Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667. — View Citation

Marsano J, Tzimas D, Mckinley M, et al. Endocuff assisted colonoscopy increases adenoma detection rates: a multi-center study. Gastrointest Endosc 2014;79(5 Suppl):AB550

Morgan J, Thomas K, Lee-Robichaud H, Nelson RL. Transparent Cap Colonoscopy versus Standard Colonoscopy for Investigation of Gastrointestinal Tract Conditions. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD008211. doi: 10.1002/14651858.CD008211.pub2. Review. Update in: Cochrane Database Syst Rev. 2012;12:CD008211. — View Citation

Pohl H, Bensen SP, Toor A, Gordon SR, Levy LC, Berk B, Anderson PB, Anderson JC, Rothstein RI, MacKenzie TA, Robertson DJ. Cap-assisted colonoscopy and detection of Adenomatous Polyps (CAP) study: a randomized trial. Endoscopy. 2015 Oct;47(10):891-7. doi: 10.1055/s-0034-1392261. Epub 2015 Jun 30. — View Citation

Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13. — View Citation

Van Doorn SC, Van Der Vlugt M, Depla AC, et al. Adenoma detection with Endocuff colonoscopy vs conventional colonoscopy: a multicenter randomised controlled trial. Gastrointest Endosc 2015;81(5 Suppl):AB145

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate	number of patients with at least one adenoma/total number of patients	7 days
Secondary	mean adenoma per patient	total number of adenoma/total number of patient	7 days