Small-Bowel Disorders
Conditions
Keywords
double-balloon endoscopy, diagnostic yield
Brief summary
Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment throughout the entire small intestine. Although the originally described method requires two operators, the investigators have recently developed a method to perform DBE by a single operator. The investigators here assessed the clinical usefulness of this one-person method in comparison to the conventional two-person DBE.
Interventions
PROCEDURESingle-operator double-balloon endoscopy
Single-operator double-balloon endoscopy
PROCEDUREdual-operator double-balloon endoscopy
dual-operator double-balloon endoscopy
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. suspected or known small-bowel disease 2. age: 16-70
Exclusion criteria
1. pregnancy 2. coagulation disorders 3. prior surgery of the small bowel and colon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| completion whether the complete enteroscopy is achieved? | 2 hours | The completion rate for examination of the entire small intestine |
| lesion-discovery | 2 hours | lesion-discovery rate |
Secondary
| Measure | Time frame |
|---|---|
| observation time | 2 hours |
| Number of Participants with Adverse Events | 2 days |
Countries
China
Outcome results
None listed