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

Small Bowel Disease Clinical Trial

Official title:

The Best Dosage and Timing of PEG for Bowel Preparation Before Capsule Endoscopy a Prospective, Single−Blind, Randomized, Multi-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486536
• Other study ID #: 2015-045k
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2015
• Last updated: June 20, 2017
• Start date: July 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Small Bowel Disease

Intervention

Drug:
• polyethylene glycol

Device:
• capsule endoscopy

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Zhizheng Ge	Huashan Hospital, Shanghai East Hospital, Shanghai Tong Ren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	day of CE procedure
Secondary	diagnostic rate		one year