Status:
COMPLETED
Pan-intestinal Capsule Endoscopy Versus Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding
Lead Sponsor:
Unidade Local de Saúde do Alto Ave, EPE
Collaborating Sponsors:
Medtronic
Conditions:
Iron Deficiency Anemia
GastroIntestinal Bleeding
Eligibility:
All Genders
8-100 years
Phase:
NA
Brief Summary
The authors hypothesize that in patients with iron deficiency anemia or gastrointestinal bleeding, pan-intestinal capsule endoscopy is a safe and well tolerated procedure that may improve diagnostic y...
Detailed Description
Patients presenting with iron deficiency anemia (IDA) or overt GI bleeding are often submitted to conventional upper GI endoscopy and colonoscopy, followed by small bowel capsule endoscopy if diagnosi...
Eligibility Criteria
Inclusion
- Patients from external consultation, hospital ward or urgency department, with suspected GI bleeding presenting in the occult form as IDA (Hb \<12.0 g/dL in female gender or \<13.0 g/dL in male gender) and/or overt GI bleeding presenting as melaena and/or haematochezia, and with prior non-diagnostic upper GI endoscopy (esophagogastroduodenoscopy, EGD)
Exclusion
- Lack of informed consent
- Suspected lesions at index EGD that could justify the anemia or digestive bleeding
- Known history of gastroparesis or bowel dysmotility
- Known or suspected intestinal stricture
- Female patients with potential gynaecological source of bleeding causative of the clinical condition
- Patients with severe malnutrition
- Patients unable to walk at least for short periods and/or with neurological and/or psychiatric condition potentially favouring protocol deviations
- Allergy or contra-indications to any of the drugs or products used in the study
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
June 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04782986
Start Date
June 19 2020
End Date
January 31 2023
Last Update
September 22 2023
Active Locations (1)
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1
Gastroenterology Department, Hospital da Senhora da Oliveira
Guimarães, Portugal, 4835-044