None listed
Conditions
Brief summary
This is a prospective pilot study into the performance of capsule endoscopy with bidirectional endoscopy (BDE) in patients with IDA. We plan to assess the accuracy and correlation of capsule endoscopy with pathology detection in patients receiving BDE for IDA. In doing so, we plan to assess for causes of IDA such as celiac and inflammatory bowel disease (especially Crohn’s disease) and can be missed by conventional endoscopy. The diagnosis of these conditions could potentially be increased with additional small bowel visualization. We plan to calculate their detection rate by capsule endoscopy.
Interventions
This is a prospective pilot study into the performance of capsule endoscopy with bidirectional endoscopy (BDE) in patients with iron deficiency anaemia (IDA).
The rationale is to assess the quality and efficacy of the capsule endoscopy intervention in comparison to bidirectional endoscopy. Each endoscopic procedure will occur once for every patient, and both the endoscopy procedures will take place in the span of 48 hours. The capsule endoscopy procedure will be carried out after the patient arr
This is a prospective pilot study into the performance of capsule endoscopy with bidirectional endoscopy (BDE) in patients with iron deficiency anaemia (IDA). The rationale is to assess the quality and efficacy of the capsule endoscopy intervention in comparison to bidirectional endoscopy. Each endoscopic procedure will occur once for every patient, and both the endoscopy procedures will take place in the span of 48 hours. The capsule endoscopy procedure will be carried out after the patient arrives at the Peri-Operative Unit at 10am, and as soon as the pill is swallowed, the patient is allowed to leave the hospital and return home if no immediate side effects appear. The patient will be asked to return the following morning for the bidirectional endoscopy procedure. After the procedure, the patient will be in the recovery room for further observation and will be allowed to leave after eliminating all side effects of the procedure. All procedures will be carried out by trained gastroenterologists with experience in bidirectional and capsule endoscopy procedures. All procedures will be carried out under a clinical setting at the Royal Prince Alfred Hospital and Chris O'Brien Lifehouse in Sydney, Australia. Intervention will be provided face-to-face and individually to each patient enrolled in the trial. Physical description of capsule used in capsule endoscopy is as follows: Brand Name: PillCam Version or Model: FGS-0662 Commercial Distribution Status: In Commercial Distribution Catalog Number: FGS-0662 Company Name: Covidien LP Primary DI Number: 07290110360559 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S® Number*: 058614483 *Terms of Use Device Description: PillCam Crohn's capsule, 1-pack
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients with IDA according to the World Health Organisation criteria: - Haemoglobin <13g/dL in men and <12g/dL in women - Mean corpuscular volume (MCV) <80 OR ferritin <12-15 mg/L 2. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Exclusion criteria
1. Active bleeding (active GI loss, epistaxis, menorrhagia, heavy menstrual blood loss) 2. GI symptoms having IDA which included dysphagia, odynophagia, heartburn, vomiting, anorexia, hematochezia, change in bowel habits, unexplained diarrhea new onset constipation (within last 6 months), and localized abdominal pain 3. Prior GI tract surgery or NSAID use. 4. Known significant medical conditions (eg, congestive heart failure, renal disease), or other known contraindications to the medications used in the study 5. Cardiac pacemaker or other implanted electromedical devices. 6. Allergies or known contraindication to the medications and preparation agents used in the procedure as described in the relevant instructions for use 7. Pregnancy.
Outcome results
None listed