Single-Operator Versus Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders (DBE)

Naval Military Medical University (Second Military Medical University)

Status and phase: Unknown; Phase 4

Conditions: Small-Bowel Disorders

Treatments: Procedure: Single-operator double-balloon endoscopy; Procedure: dual-operator double-balloon endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01184690

DBE-S vs D

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Single-operator DBE

Active Comparator group

Description:

Single-operator double-balloon endoscopy

Treatment:

Procedure: Single-operator double-balloon endoscopy

Dual-operator DBE

Active Comparator group

Description:

Dual-operator double-balloon endoscopy

Treatment:

Procedure: dual-operator double-balloon endoscopy