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Completed

NCT Number: NCT02486536

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

The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation in patients referred for CE examination.

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Key information

Conditions

Small Bowel Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyethylene glycol

Drug

capsule endoscopy

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Zhizheng Ge

Other

Collaborators

  • Huashan Hospital
  • Shanghai East Hospital
  • Shanghai Tong Ren Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 1, 2015
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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