Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy

Training and Validation of Models Based on Patient-related or Procedure-related Factors to Predict Inadequate Bowel Preparation in Patients Undergoing Colonoscopy

The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadeqaute bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offerred to achieve better bowel cleasing. Currently, there were three predicting models of inadequate bowel preparation eatablished based on patient-related factors. It remains unclear which model perfroms better in predicting bowel preparation quality. Futhermore, althought those predicting models only composing of patients-related factors are useful for identifing high-risk patients, the preparation-related factors may also be valuable for prediciting inadeqaute bowel preparation before the procedure of colonoscopy.

This study aimed: 1) to compare the values of three availlable models (based on patient-related factors) in predicting inadeqaute bowel preparation in a prospective, multicentered cohort of patients undergoing colonoscopy; 2) to investigate whether a new model based on preparation-related or a combined model based on patient-related and preparation-related factors is comparable to previous models based on patient-related factors.

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Bowel Preparation; Predictive Model
• Intervention / Treatment: Other

• Study Type: Observational
• Enrollment (Actual): 900

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Department of Gastroenterology, Hongai Hospital
  • Guangdong
    • Shenzhen, Guangdong, China, 510000
      • Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University
  • Henan
    • Kaifeng, Henan, China, 475000
      • Department of Gastroenterology, Huaihe Hospital of Henan University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710005
      • Department of gastroenterology, Shaanxi Second People's Hospital
    • Xi'an, Shaanxi, China, 710032
      • Endoscopic center, Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Using PEG for bowel preparation before colonoscopy

Description

Inclusion Criteria:

• Aged 18-80
• Using PEG for bowel preparation before colonoscopy

Exclusion Criteria:

• Not undergoing standard bowel preparation due to emergency, bleeding or unsuitable for preparation
• Colon resection
• Suspected bowel obstruction
• Hemodynamically unstable
• Lactating or pregnant women
• Unwilling to provided informed content

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
training group; All patients received oral and written instructions on the appointment day. All patients were instructed to have low-residue food for lunch and dinner on the day before colonoscopy. Patients were instructed to begin drinking the first 1.5L-2L PEG at 7:00-9:00 PM on the day before colonoscopy. On the day of the procedure, they took another 1.5L-2L 4-6 hours before colonoscopy. Patients were encouraged more to drink more clear liquids after purgatives for adequate hydration.
validation group; All patients received oral and written instructions on the appointment day. All patients were instructed to have low-residue food for lunch and dinner on the day before colonoscopy. Patients were instructed to begin drinking the first 1.5L-2L PEG at 7:00-9:00 PM on the day before colonoscopy. On the day of the procedure, they took another 1.5L-2L 4-6 hours before colonoscopy. Patients were encouraged more to drink more clear liquids after purgatives for adequate hydration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inadequate bowel preparation	Inadequate bowel preparation was defined by the Boston Bowel Preparation Scale of any segmental<2.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy of proximal bowel preparation	Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of right-colon<2 or middle colon<2	1 hour
Adequacy of distal bowel preparation	Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of left-colon<2 or middle colon<2	1 hour

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Collaborators: Shenzhen Hospital of Southern Medical University; Huaihe Hospital of Henan University; Xiamen Hongai Hospital; Shaanxi Second People's Hospital

Publications and helpful links

General Publications

• Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.
• Dik VK, Moons LM, Huyuk M, van der Schaar P, de Vos Tot Nederveen Cappel WH, Ter Borg PC, Meijssen MA, Ouwendijk RJ, Le Fevre DM, Stouten M, van der Galien O, Hiemstra TJ, Monkelbaan JF, van Oijen MG, Siersema PD; Colonoscopy Quality Initiative. Predicting inadequate bowel preparation for colonoscopy in participants receiving split-dose bowel preparation: development and validation of a prediction score. Gastrointest Endosc. 2015 Mar;81(3):665-72. doi: 10.1016/j.gie.2014.09.066. Epub 2015 Jan 17.
• Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2019
• Primary Completion (ACTUAL): March 30, 2020
• Study Completion (ACTUAL): March 30, 2020

Study Registration Dates

• First Submitted: September 21, 2019
• First Submitted That Met QC Criteria: September 21, 2019
• First Posted (ACTUAL): September 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 14, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: factors;bowel preparation;colonoscopy
• Other Study ID Numbers: KY20190903-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No