CompletedNot Applicable

Acceptability and Tolerability of Magnetic Assisted Capsule Endoscopy Compared to Gastroscopy

United Kingdom69 participantsStarted 2017-03-07

Plain-language summary

Dyspepsia is a common presenting complaint that doctors have to manage and this is true both in the primary and secondary care setting. OGD is a useful test for investigating a variety of suspected upper GI disorders including dyspepsia. However, it is uncomfortable for patients and incurs the risk of intubation and sedation. Capsule endoscopy (CE) 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. The investigators wish to undertake a prospective study comparing acceptability and tolerability of MACE and OGD 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 MACE prior to OGD performed by an endoscopist blinded to the MACE 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 18 years and over and up to but not exceeding 80 years * Patients presenting symptoms of dyspepsia whom require gastroscopy as per national guidelines Exclusion Criteria: Patients under the age of 18 years * Patients over the age of 80 years * Active vomiting * Patients with a permanent pacemaker, implantable cardioverter-defibrillator or REVEAL device * Patients with any electronic/magnetic/mechanically controlled devices e.g. sacral nerve stimulators, bladder stimulators * Patients with dysphagia, odynophagia or known swallowing disorder * Patients with known Zenker's diverticulum * Patients with suspected bowel obstruction or bowel perforation * Patients with prior bowel obstruction * Patients with gastroparesis or known gastric outlet obstruction * Patients with known Crohn's disease * Patients who are taking daily non-steroidal anti-inflammatory drugs (excluding prophylactic doses of aspirin) for more than six months * Patients who have received abdominopelvic radiotherapy treatment * Patients with a history of GI tract surgery (Billroth I, Billroth II, Oesophagectomy, gastrectomy or bariatric procedure) * Patients that are pregnant or lactating * Patients with altered mental status that would limit their ability to swallow * Patients with allergy to conscious sedation or metoclopramide * Patients unwilling to swallow the capsule * Patients with known dementia affecting ability to consent * Patients who are unable to understand or …

What they're measuring

Endoscopy Concerns Score

Timeframe: procedure

Trial details

NCT IDNCT03420729

SponsorSheffield Teaching Hospitals NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-01