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OpenTrials
Completed

NCT Number: NCT02093156

A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy

Colonoscopy is the current standard method for evaluating the colorectal diseases. Adequate bowel preparation is essential for optimal visualization of the colorectal mucosa. However, inadequate bowel preparation (IBP) had been unexpectedly reported in up to 30% of patients undergoing colonoscopy. Many factors may influence the quality of bowel preparation, which can be broadly categorized as patient-related or procedure-related. It has been shown that split-dose regimen or some modified educational strategies can improve the quality of bowel preparation. For the patients with possible IBP before the performing of colonoscopy, it may be better to repeat bowel preparation with modified or enhanced strategies in case of failed intubation, missed lesions or unnecessarily increased cost. Thus, it is important to set up a model to predict the quality of bowel preparation individually.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endoscopic center, Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi, China

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients aged 18-90 years old who undergoing colonoscopy

Exclusion criteria

  • failed colonoscopy because of technical chanllenge or poor tolerance of patients
  • history of colorectal surgery
  • prior finding of severe colonic stricture or obstructing tumor
  • dysphagia
  • compromised swallowing reflex or mental status
  • significant gastroparesis or gastric outlet obstruction or ileum
  • known or suspected bowel obstruction or perforation
  • pregnancy
  • unable to give informed consent

Treatment and study plan

Bowel preparation instructions

Other

The same-day preparation method was used as previously reported. Briefly, all patients were instructed to have a regular diet for breakfast and lunch, but only clear liquids for dinner on the day before the colonoscopy. They were asked to drink two bags of PEG-ELP (polyethylene glycol electrolyte powder) dissolved in 2 L of water, or 45 mL of sodium phosphate be diluted in 240 mL of cool water follow with at least 1.5 L of water at 05:00-06:00 h within 2 h on the day of colonoscopy. Patients were encouraged to drink more clear liquids after purgatives for adequate hydration before colonoscopy.

Primary outcomes

  1. Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6

    Time frame: up to 4 months

    Ottawa score:A)cleanliness of each part of the colon: 0=excellent 1=good 2=fair 3=poor 4=inadequate B)fluid in whole colon: small=0 moderate=1 large=2

    The bowel preparation was considered inadequate if (1) inadequate visualization on colonoscopy defined by Ottawa score≥6; (2) the colonoscopy was cancelled because of poor bowel preparation or personal reasons.

Secondary outcomes

  1. Polyp detection rate

    Time frame: up to 4 months

    The proportion of participants with at least one polyp in each group

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2014
Registry last updated
Mar 20, 2014

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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