None listed
Conditions
Brief summary
All patients with upper gastrointestinal bleeding (UGIB) undergo a gastroscopy urgently. However, in a significant proportion of these patients a source is not identified. Small bowel bleeding is highly likely to be the source in a large number of these patients. This may be identified by capsule endoscopy. Proximal colonic bleeding is also likely in patients with melaena and is identifiable by colonoscopy. As per current standard practice, patients will undergo a colonoscopy frequently or a capsule endoscopy (CE) less often, in an attempt to find the cause of bleeding. Capsule endoscopy is noninvasive, better tolerated and preferred by patients as bowel prep and anaesthesia are not required. However,it is uncertain who will benefit most by having a capsule endoscopy as the second test. The focus of our study is to look at the subgroup of patients who will benefit most by having early Capsule Endoscopy in this context. The study aims to compare two groups of patients, one having capsule endoscopy VS the other having colonoscopy as the second test following a negative gastroscopy to determine differences in ability to detect bleeding source and therefore change patient outcome. All patients with UGIB with a negative gastroscopy will be considered for the study. This is a prospective randomised control trial. Primary endpoint measured will be identification of the source of bleeding. Secondary endpoints measured will be reduced blood transfusions, reduced length of stay, reduced number of investigations and reduced hospital admissions.
Interventions
This research involves procedures and clinical care which are performed as standard practice currently. Patients with a negative gastroscopy will be randomised to either the control group and receive a Colonoscopy, or the intervention group and receive a Capsule Endoscopy as their second investigation.
Those patients randomised to the Capsule Endoscopy group will be orally administered a single disposable endoscopy capsule which will pass through the gastrointestinal tract taking continuous imag
This research involves procedures and clinical care which are performed as standard practice currently. Patients with a negative gastroscopy will be randomised to either the control group and receive a Colonoscopy, or the intervention group and receive a Capsule Endoscopy as their second investigation. Those patients randomised to the Capsule Endoscopy group will be orally administered a single disposable endoscopy capsule which will pass through the gastrointestinal tract taking continuous images that will be sent to a data receiver, This data will be downloaed and interpreted by a trained gastroenterologist. This will all be completed during athe same inpatient hospital admission.
Sponsors
QLD Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be males or females who present with acute melaena and/or haematemesis and have a negative gastroscopy.
Exclusion criteria
Patients less than 18 years of age and pregnant females will be excluded form this study.
Outcome results
None listed