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van CCT (UK)

van CCT (UK)

Prevalence of gastrointestinal disorders in the general population 50 to 75 years in the Ommoord municipality: videocapsule in the Rotterdam study

- candidate number25687
- NTR NumberNTR6321
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-dec-2016
- Secondary IDs1. MEC-2015-453; 2. 40-43100-98-011 1.Medical Ethics Committee of Erasmus Medical Center; 2. Health~Holland
- Public TitlePrevalence of gastrointestinal disorders in the general population 50 to 75 years in the Ommoord municipality: videocapsule in the Rotterdam study
- Scientific TitlePrevalence of gastrointestinal disorders in the general population 50 to 75 years in the Ommoord municipality: videocapsule in the Rotterdam study
- ACRONYMVideocapsule_ERGO
- hypothesis
- Healt Condition(s) or Problem(s) studiedGastrointestinal disease, Videocapsule endoscopy
- Inclusion criteriaSubject aged 50 untill 74 years old; Participation in the Rotterdam study
- Exclusion criteriaInability or refusal to provide informed consent; Persons with a severe or terminal disease with a life-expectancy of less than 5 years; Dysphagia or other swallowing disorder which makes it impossible to swallow the capsule; Renal failure, eGFR <30 ml/min/1.73m2; Subject has congestive heart failure (NYHA class 3 and 4); Subject has any allergy or other known contraindication to the medications used in the study; High risk of capsule retention: IBD, Personal history of Gastrointestinal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator; Cardiac pacemakers or other implanted electro-medical equipment; Subject is expected to undergo MRI examination within14 days after ingestion of the capsule; Presumably or proven congenital long QT syndrome; Participants who use medication that give an extension of the QT- interval; subject has insulin dependent diabetes
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-feb-2017
- planned closingdate
- Target number of participants1000
- InterventionsColon capsule endoscopy with corresponding bowel preparation
- Primary outcomePrevalence of gastrointestinal disorders, visualized with colon capsule endoscopy
- Secondary outcomeParticipation, prevalence of adverse events; burden of colon capsule endoscopy (CCE); compare results CCE with result endoscopy; referral rate; compare patient characteristics, medication use and demographical aspects between persons with and without found lesions.
- Timepointsn.a.
- Trial web site
- statusplanned
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Health~Holland (previously known as Foundation LSH-TKI), Covidean AG, Stichting Koningin Wilhelmina Fonds voor de Nederlands Kankerbestrijding (KWF): a health fund in The Netherlands , Camerapil B.V.
- Publications
- Brief summaryThe Rotterdam study (ERGO) is a prospective cohort study in the Ommoord district in the city of Rotterdam, The Netherlands.
Gastrointestinal diseases are common in the elderly population but accurate figures are unknown, partly because it is present without symptoms. For this reason, the true prevalence in the general population is unknown, mainly since most studies are performed in symptomatic populations.
Video Capsule Endoscopy (VCE) provides images of he entire gastrointestinal tract and can therefore be used to identify gastrointestinal disorders. Participants invited to video capsule endoscopy will be using the PillCam Colon 2 (Covidean AG). This capsule is 11,6 mm x 32.7 mm in size and each colon capsule has two imagers allowing nearly 360 coverage of the colon.
The study population consists of participants of the Rotterdam Study, aged between 50-74 years old. 1000 Persons will be included in the study. The primary aim of the study is the prevalence of inflammation, ulcerations and erosions of the gastrointestinal tract; Barrets esophagus; celiac disease; gastrointestinal bleeding, small bowel polyps and lager bowel polyps.
Further, in additional analysis, we will relate the prevalence with the information obtained from ERGO, such as factors as drug use, medical history and other determinants. In addition, the findings are compared with the findings at endoscopy of subjects are referred for endoscopy.
- Main changes (audit trail)
- RECORD23-dec-2016 - 27-mei-2017

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