A Pilot Study into a Pan-Enteric Capsule Endoscopy vs. Bidirectional Endoscopy In Patients With Iron Deficiency Anaemia.

Not Applicable

Not yet recruiting

Conditions: Iron Deficiency Anaemia
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Blood - Anaemia

Registration Number: ACTRN12619000250134

Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 50

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the sensitivity of capsule endoscopy for IDA in relation to bidirectional endosocpy[Primary outcomes of each patient will be measured after both procedures are complete and results have been interpreted by the interventional endoscopist performing the procedures. ];To assess the specificity of capsule endoscopy in relation to bidirectional endoscopy for IDA[Primary outcomes of each patient will be measured after both procedures are complete and results have been interpreted by the interventional endoscopist performing the procedures. ]

Secondary Outcome Measures

Name	Time	Method
To assess the safety of capsule endoscopy and the types of missed lesions on capsule endoscopy<br><br>[Secondary outcomes of each patient will be measured along with primary outcomes after results of both procedures are interpreted. ]