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Completed

NCT Number: NCT03142854

Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model

About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Ji'nan, Shandong, 250012, China

About this study

Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to create and verify a predictive model for inadequate bowel preparation. Then, in order to improve adequate bowel preparation rate, we aim to establish a bowel preparation strategy guided by the predicted model and verify it.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients aged 18 or older
  • patients undergoing colonoscopy

Exclusion criteria

  • patients with a history of colorectal surgery
  • patients with severe colonic stricture or obstructing tumor
  • patients with dysphagia
  • patients with compromised swallowing reflex or mental status
  • patients with significant gastroparesis or gastric outlet obstruction
  • patients with known or suspected bowel obstruction or perforation
  • patients with severe chronic renal failure (creatinine clearance<30 ml/min)
  • patients with severe chronic renal failure (creatinine clearance<30 ml/min)
  • patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
  • patients with inflammatory bowel disease or megacolon
  • patients with dehydration
  • patients with dehydration
  • patients with pregnancy or lactation
  • patients hemodynamically unstable
  • patients unable to give informed consent

Treatment and study plan

Polyethylene Glycol (PEG)

Drug

participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.

Primary outcomes

  1. adequate bowel preparation rates between 2 groups.

    Time frame: 4 months

    adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model: a Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 8, 2017
Registry last updated
Sep 11, 2017

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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