The Best Dosage and Timing of Polyethylene Glycol for Bowel Preparation Before Capsule Endoscopy

Zhizheng Ge

Status and phase: Completed; Phase 4

Conditions: Small Bowel Disease

Treatments: Device: capsule endoscopy; Drug: polyethylene glycol

Study type: Interventional

Funder types: Other

Identifiers

NCT02486536

2015-045k

Details and patient eligibility

About

The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation in patients referred for CE examination.

Enrollment: 410 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged between 18 and 75 years and referred to capsule endoscopy because of suspected small-bowel disease are prospectively eligible for entry into the study.

Exclusion criteria

• Age < 18 or > 75 years
• Known or suspected GI stricture or fistula
• A history of GI tract resection
• Swallowing disorders
• Intensive therapy with fasting and parenteral nutrition;with a disease that may reduce movement of the GI tract, such as diabetes mellitus
• Medications that could affect gastrointestinal movement within one week
• Implanted with a medical electronic device
• Active inflammatory bowel disease, toxic megacolon, toxic colitis
• Severe pulmonary, cardiac, renal, or hepatic disease
• Uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg);
• Disturbance of electrolytes
• Pregnancy or lactation
• Patients inability to provide written voluntary informed consent
• Participation in another clinical study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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410 participants in 5 patient groups

Group A

Active Comparator group

Description:

Fast for 12h before the examination and take 8ml of Simethicone Emulsion (Berlin-Chemie, Germany, containing 40 mg simethicone in 1mL emulsion) with 250ml water 30min before capsule ingestion.CE are performed with the Pillcam SB2 capsule endoscopy system (Given Imaging Co. Ltd., Yoqnem, Israel).

Treatment:

Device: capsule endoscopy

Group B

Active Comparator group

Description:

the same as protocol A plus 1L Polyethylene glycol 11-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.

Treatment:

Drug: polyethylene glycol

Device: capsule endoscopy

Group C

Active Comparator group

Description:

the same as protocol A plus 2L Polyethylene glycol 10-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.

Treatment:

Drug: polyethylene glycol

Device: capsule endoscopy

Group D

Active Comparator group

Description:

Group D: the same as protocol A plus 1L Polyethylene glycol 3-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.

Treatment:

Drug: polyethylene glycol

Device: capsule endoscopy

Group E

Active Comparator group

Description:

Group E: the same as protocol A plus 2L Polyethylene glycol 2-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.

Treatment:

Drug: polyethylene glycol

Device: capsule endoscopy