Comparison of Two Devices During Colonoscopy
COLONAUX
Endocuff vs Transparent Cap To Increase Adenoma Detection Rate During Colonoscopy
1 other identifier
interventional
710
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 22, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedNovember 7, 2018
November 1, 2018
1.2 years
June 22, 2017
November 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma detection rate
number of patients with at least one adenoma/total number of patients
7 days
Secondary Outcomes (1)
mean adenoma per patient
7 days
Study Arms (2)
Endocuff colonoscopy
EXPERIMENTALEndocuff-assisted colonoscopy
Cap colonoscopy
ACTIVE COMPARATORCap-assisted colonoscopy
Interventions
Eligibility Criteria
You may qualify if:
- All patients who are attending for screening, surveillance or diagnostic colonoscopy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Related Publications (13)
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.
PMID: 20463339BACKGROUNDFloer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel 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.
PMID: 25470133BACKGROUNDvan Doorn SC, van der Vlugt M, Depla A, Wientjes CA, Mallant-Hent RC, Siersema PD, Tytgat K, Tuynman H, Kuiken SD, Houben G, Stokkers P, Moons L, Bossuyt P, Fockens P, Mundt MW, Dekker E. Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial. Gut. 2017 Mar;66(3):438-445. doi: 10.1136/gutjnl-2015-310097. Epub 2015 Dec 16.
PMID: 26674360BACKGROUNDMarsano 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
BACKGROUNDBiecker E, Floer M, Heinecke A, Strobel P, Bohme 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.
PMID: 24921209BACKGROUNDHoriuchi 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.
PMID: 19716434BACKGROUNDRastogi 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.
PMID: 21997547BACKGROUNDHewett 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.
PMID: 20579648BACKGROUNDFrieling T, Neuhaus F, Kuhlbusch-Zicklam R, Heise J, Kreysel C, Hulsdonk 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.
PMID: 24338756BACKGROUNDde 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.
PMID: 22187070BACKGROUNDMorgan 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.
PMID: 21328306BACKGROUNDPohl 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.
PMID: 26126162BACKGROUNDSola-Vera J, Catala L, Uceda F, Pico MD, Perez Rabasco E, Saez J, Jimenez N, Arjona MD, Fernandez M, Girona E, Garcia-Sepulcre MF. Cuff-assisted versus cap-assisted colonoscopy for adenoma detection: results of a randomized study. Endoscopy. 2019 Aug;51(8):742-749. doi: 10.1055/a-0901-7306. Epub 2019 May 16.
PMID: 31096275DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Javier Sola Vera, Ph.D.
Hospital General Universitario de Elche
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D, Ph D
Study Record Dates
First Submitted
June 22, 2017
First Posted
June 23, 2017
Study Start
June 1, 2017
Primary Completion
July 31, 2018
Study Completion
July 31, 2018
Last Updated
November 7, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share