Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Freiburg

About this trial

Small bowel capsule endoscopy is the main diagnostic standard for small bowel bleeding. This study investigates the detection rate of small bowel bleeding in capsule endoscopy and further endoscopic treatment in a prospective and retrospective cohort.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

suspicion of gastrointestinal bleeding in the small bowel undetected by gastroscopy and colonoscopy

informed consent

Disqualifiers

contraindications for small bowel capsule endoscopy (e.g. stenosis)

Trial population

Patients who present with gastrointestinal bleeding undetected in gastroscopy or colonoscopy will be included in this cohort study. In these patients bleeding in the small bowel is suspected and they are allocated to a diagnostic assessment with small bowel capsule endoscopy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Small bowel capsule endoscopy

    Device

    Patients with gastrointestinal bleeding receive small bowel capsule endoscopy after bleeding could not be located in gastroscopy or colonoscopy.

Treatment groups

1,300 Participants
are divided into 1 treatment group
Group A: Patients with gastrointestinal bleeding undetected in gastroscopy and colonoscopy1 intervention

Trial outcomes

Primary outcomes

1

Prevalence of small bowel bleeding detected during small bowel capsule endoscopy

Detection of bleeding during small bowel capsule endoscopy

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Prevalence of vascular lesions as source of bleeding

Detection of vascular lesions angiodysplasia) as source of bleeding

Time frame
Through study completion, an average of 1 year
2

Prevalence of inflammatory lesions as source of bleeding

Detection of inflammatory lesions as source of bleeding

Time frame
Through study completion, an average of 1 year
3

Prevalence of tumor lesions as source of bleeding

Detection of tumor lesions as source of bleeding

Time frame
Through study completion, an average of 1 year
4

Complications of small bowel capsule endoscopy

Complications of small bowel capsule endoscopy

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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