The Best Dosage and Timing of Polyethylene Glycol for Bowel Preparation Before Capsule Endoscopy
1 other identifier
interventional
410
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJune 22, 2017
June 1, 2017
1.9 years
June 24, 2015
June 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the quality of visualization of the small bowel
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.
one week after CE procedure
Secondary Outcomes (2)
patient acceptability
day of CE procedure
diagnostic rate
one year
Study Arms (5)
Group A
ACTIVE COMPARATORFast 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
ACTIVE COMPARATORthe same as protocol A plus 1L Polyethylene glycol 11-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
Group C
ACTIVE COMPARATORthe same as protocol A plus 2L Polyethylene glycol 10-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
Group D
ACTIVE COMPARATORGroup 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
ACTIVE COMPARATORGroup E: the same as protocol A plus 2L Polyethylene glycol 2-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhizheng Gelead
- Huashan Hospitalcollaborator
- Shanghai East Hospitalcollaborator
- Shanghai Tong Ren Hospitalcollaborator
Study Sites (3)
Huashan Hospital
Shanghai, Shanghai Municipality, 200040, China
Tongren Hospital Affiliated to Shanghai Jiaotong University, China
Shanghai, Shanghai Municipality, 200050, China
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Related Publications (1)
Wu S, Zhong L, Zheng P, Wang YG, Ding WQ, Yu Q, Hui PP, Chen HM, Gao YJ, Ge ZZ. Low-dose and same day use of polyethylene glycol improves image of video capsule endoscopy: A multi-center randomized clinical trial. J Gastroenterol Hepatol. 2020 Apr;35(4):634-640. doi: 10.1111/jgh.14899. Epub 2019 Dec 15.
PMID: 31682026DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 24, 2015
First Posted
July 1, 2015
Study Start
July 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
June 22, 2017
Record last verified: 2017-06