Acceptability and tolerability of MACE compared to gastroscopy
Research type
Research Study
Full title
Acceptability and tolerability of magnetic assisted capsule endoscopy compared to gastroscopy
IRAS ID
216489
Contact name
Mark McAlindon
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Summary of Research
Dyspepsia is a common presenting complaint that doctors have to manage both in the primary and secondary care setting. Gastroscopy is a useful test for investigating a variety of suspected upper gastrointestinal disorders including dyspepsia. However, it is uncomfortable for patients and incurs the risk of intubation and sedation. Capsule endoscopy is the investigation of choice for diseases of the small bowel. It is safe, non-invasive and well tolerated, the main risk being capsule retention occurring in up to 1-2% of procedures.We wish to undertake a prospective study comparing acceptability and tolerability of capsule endoscopy and gastroscopy in the investigation of dyspepsia. Patients presenting to general practice or the outpatients department with symptoms of dyspepsia who are referred for investigation are invited to take part in the study. Patients will undergo capsule endoscopy prior to gastroscopy performed by an endoscopist who will be blinded to the Capsule endoscopy findings. A comparison of tolerance and acceptance of both procedures will be measured by means of using structured and validated, qualitative questionnaires. The aim is to assess for whether there is a significant difference between the perception and experience of both modalities.
Summary of Results
Patient acceptability of conventional fibreoptic gastroscopy, transnasal endoscopy (TNE) and magnetic assisted capsule endoscopy (MACE) was compared. Sensations of gagging and choking related to instrumentation caused the most distress during gastroscopy, significantly moreso than during MACE. Intrumentation-related discomfort was also significantly greater during TNE than MACE. MACE was more acceptable to, and preferred by, patients than either gastroscopy or TNE.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0606
Date of REC Opinion
24 Nov 2016
REC opinion
Further Information Favourable Opinion