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

Phase 4

• Conditions: Small-Bowel Disorders
• Interventions: Procedure: Single-operator double-balloon endoscopy; Procedure: dual-operator double-balloon endoscopy

• Registration Number: NCT01184690
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-08
• Study Start: 2010-08
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-18
• Last Update Submitted: 2010-08-18
• Study First Posted: 2010-08-19
• Last Update Posted: 2010-08-19
• Primary Completion: 2011-08
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-operator DBE	Single-operator double-balloon endoscopy	Single-operator double-balloon endoscopy
Dual-operator DBE	dual-operator double-balloon endoscopy	Dual-operator double-balloon endoscopy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
observation time	2 hours
Number of Participants with Adverse Events	2 days

Trial Locations

Locations (1)

Shanghai changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China