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

Phase 4

Completed

• Conditions: Small Bowel Disease
• Interventions: Drug: polyethylene glycol; Device: capsule endoscopy

• Registration Number: NCT02486536
• Lead Sponsor: Zhizheng Ge

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-30
• Study Start: 2015-07
• Study First Posted: 2015-07-01
• Status Verified: 2017-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	polyethylene glycol	the same as protocol A plus 2L Polyethylene glycol 10-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
Group C	capsule endoscopy	the same as protocol A plus 2L Polyethylene glycol 10-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
Group E	capsule endoscopy	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.
Group A	capsule endoscopy	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).
Group B	capsule endoscopy	the same as protocol A plus 1L Polyethylene glycol 11-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
Group D	capsule endoscopy	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.
Group B	polyethylene glycol	the same as protocol A plus 1L Polyethylene glycol 11-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
Group D	polyethylene glycol	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.
Group E	polyethylene glycol	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.

Primary Outcome Measures

Name	Time	Method
the quality of visualization of the small bowel	one week after CE procedure	The image quality was evaluated only in cases in which the capsule reached the cecum within the examination period. All CE images will be assessed at low speed (10 frames/s) under the AutoView mode of the RAPID workstation (Given Imaging). The intestinal mucosa is defined as clean if, less than 25% of the mucosal surface was covered by dark liquid, bubbles or debris. Using a timer, the investigators record the exact time period during which the small intestinal mucosa was clean. The definition of "excellent" is at least 90% of the overall small bowel mucosa is clean (the sum of "clean" time /total small bowel transit time\>90%). And the definition of "good" is at least 80% of the overall small bowel mucosa is clean. We considered that "excellent" or "good" preparation is adequate to make an accurate diagnosis.

Secondary Outcome Measures

Name	Time	Method
diagnostic rate	one year
patient acceptability	day of CE procedure	A visual analogical scale (VAS) is used to evaluate the degree of patients' discomfort. The numerical scale between 0 and 10, with 0 being no burden at all and 10 indicating an intolerable procedure.; The questionnaire provide information about whether they experienced nausea, bloating, or any discomfort during the bowel preparation, difficulty to complete the preparation, their willingness to repeat the same preparation in the future (yes or no)and did it affect their daily activity and nocturnal rest.

Trial Locations

Locations (3)

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China

Tongren Hospital Affiliated to Shanghai Jiaotong University, China; 🇨🇳 Shanghai, Shanghai, China

Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China