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

Primary Purpose

Small Bowel Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
polyethylene glycol
capsule endoscopy
Sponsored by
Zhizheng Ge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Small Bowel Disease focused on measuring capsule endoscopy, polyethylene glycol, bowel preparation solutions

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Huashan Hospital
  • Tongren Hospital Affiliated to Shanghai Jiaotong University, China
  • Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm 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).

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

patient acceptability
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.
diagnostic rate

Full Information

First Posted
June 24, 2015
Last Updated
June 20, 2017
Sponsor
Zhizheng Ge
Collaborators
Huashan Hospital, Shanghai East Hospital, Shanghai Tong Ren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02486536
Brief Title
The Best Dosage and Timing of Polyethylene Glycol for Bowel Preparation Before Capsule Endoscopy
Official Title
The Best Dosage and Timing of PEG for Bowel Preparation Before Capsule Endoscopy a Prospective, Single-Blind, Randomized, Multi-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhizheng Ge
Collaborators
Huashan Hospital, Shanghai East Hospital, Shanghai Tong Ren Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Disease
Keywords
capsule endoscopy, polyethylene glycol, bowel preparation solutions

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm 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).
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
the same as protocol A plus 1L Polyethylene glycol 11-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
the same as protocol A plus 2L Polyethylene glycol 10-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
Arm Title
Group D
Arm Type
Active Comparator
Arm 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.
Arm Title
Group E
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
polyethylene glycol
Intervention Type
Device
Intervention Name(s)
capsule endoscopy
Primary Outcome Measure Information:
Title
the quality of visualization of the small bowel
Description
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.
Time Frame
one week after CE procedure
Secondary Outcome Measure Information:
Title
patient acceptability
Description
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.
Time Frame
day of CE procedure
Title
diagnostic rate
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Tongren Hospital Affiliated to Shanghai Jiaotong University, China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Facility Name
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31682026
Citation
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.
Results Reference
derived

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

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