A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT02093156
First received: March 19, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose
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.

Condition Intervention
Bowel Preparation
Ottawa Score
Other: Bowel preparation instructions

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy

Resource links provided by NLM:


Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6 [ Time Frame: up to 4 months ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Polyp detection rate [ Time Frame: up to 4 months ] [ Designated as safety issue: No ]
    The proportion of participants with at least one polyp in each group


Enrollment: 605
Study Start Date: September 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
training cohort
the training cohort was used to establish the bowel preparation score (BPS)
Other: Bowel preparation instructions
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.
validation cohort
the validation cohort was used to verify the BPS (bowel preparation score)
Other: Bowel preparation instructions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This is a prospective study involving two tertiary centers in China. The patients of the training cohort were enrolled from the Endoscopy Center of Xijing Hospital of Digestive Diseases in China. The patients of the validation cohort were enrolled from the Shaanxi Second People's Hospital in China.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02093156

Locations
China, Shaanxi
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
Shaanxi Second People's Hospital
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
  More Information

Additional Information:
Responsible Party: Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02093156     History of Changes
Other Study ID Numbers: 20130910-3 
Study First Received: March 19, 2014
Last Updated: March 19, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Fourth Military Medical University:
bowel preparation
Ottawa Score

ClinicalTrials.gov processed this record on August 24, 2016