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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26263
Enrollment
1000
Registered
2016-12-23
Start date
2017-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Videocapsule endoscopy

Interventions

Colon capsule endoscopy with corresponding bowel preparation

Sponsors

Erasmus Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subject aged 50 untill 74 years old; Participation in the Rotterdam study

Exclusion criteria

Exclusion criteria: Inability 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

Design outcomes

Primary

MeasureTime frame
Prevalence of gastrointestinal disorders, visualized with colon capsule endoscopy

Secondary

MeasureTime frame
Participation, 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.

Contacts

Public ContactM.C.W. Spaander

Erasmus Medical Center Rotterdam

v.spaander@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)