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

• ClinicalTrials.gov Identifier: NCT02486536
• Recruitment Status: Completed
• First Posted: July 1, 2015
• Last Update Posted: June 22, 2017
• Sponsor: Zhizheng Ge
• Collaborators: Huashan Hospital; Shanghai East Hospital; Shanghai Tong Ren Hospital
• Information provided by (Responsible Party): Zhizheng Ge, Shanghai Jiao Tong University School of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Small Bowel Disease	Drug: polyethylene glycol; Device: capsule endoscopy	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 410 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: The Best Dosage and Timing of PEG for Bowel Preparation Before Capsule Endoscopy a Prospective, Single-Blind, Randomized, Multi-center Study
• Study Start Date: July 2015
• Actual Primary Completion Date: June 2017
• Actual Study Completion Date: June 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group A; 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).	Device: capsule endoscopy
Active Comparator: Group B; the same as protocol A plus 1L Polyethylene glycol 11-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.	Drug: polyethylene glycol; Device: capsule endoscopy
Active Comparator: Group C; the same as protocol A plus 2L Polyethylene glycol 10-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.	Drug: polyethylene glycol; Device: capsule endoscopy
Active Comparator: Group D; 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.	Drug: polyethylene glycol; Device: capsule endoscopy
Active Comparator: Group E; 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.	Drug: polyethylene glycol; Device: capsule endoscopy

Outcome Measures

Primary Outcome Measures :

1. the quality of visualization of the small bowel [ Time Frame: 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 :

1. patient acceptability [ Time Frame: 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.

2. diagnostic rate [ Time Frame: one year ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China, Shanghai

Huashan Hospital

Shanghai, Shanghai, China, 200040

Tongren Hospital Affiliated to Shanghai Jiaotong University, China

Shanghai, Shanghai, China, 200050

Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai, China, 200127

Sponsors and Collaborators

Zhizheng Ge

Huashan Hospital

Shanghai East Hospital

Shanghai Tong Ren Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Zhizheng Ge, MD, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT02486536
• Other Study ID Numbers: 2015-045k
• First Posted: July 1, 2015
• Last Update Posted: June 22, 2017
• Last Verified: June 2017

Keywords provided by Zhizheng Ge, Shanghai Jiao Tong University School of Medicine:

capsule endoscopy; polyethylene glycol; bowel preparation solutions

Additional relevant MeSH terms:

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases