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Trial record 28 of 279 for:    Best Disease

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

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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



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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486536


Locations
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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

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Responsible Party: Zhizheng Ge, MD, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02486536     History of Changes
Other Study ID Numbers: 2015-045k
First Posted: July 1, 2015    Key Record Dates
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