The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors

The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors: a Multicenter, Randomized Controlled Study

The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadequate bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offered to achieve better bowel cleaning. Currently, there were three predicting models of inadequate bowel preparation established based on patient-related factors. So far, none of predictive models have been tested in other than their validation cohort populations, and no study has attempted to apply a different regimen to patients presenting with risk factors for inadequate colon cleanliness. In previous studies, we established a prediction model based on procedure-related factors, which has better accuracy and can better predict the quality of bowel preparation.

The aim of this study is to compare the quality of bowel preparation by using a predictive model based on procedure-related factors versus the criterion group in unsedation patients

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Bowel Preparation; Predictive Model
• Intervention / Treatment: Drug: Polyethylene glycol

• Study Type: Interventional
• Enrollment (Actual): 900
• Phase: Not Applicable

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 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: 18~75 years
• Patients undergoing morning colonoscopy

Exclusion Criteria:

• colon resection;
• suspected bowel obstruction;
• moderate or severe complications related to drinking the 1st or 2rd dose of PEG
• hemodynamically unstable;
• lactating or pregnant women;
• no need to reach the ileocecal segment
• unwilling to provided informed content.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Colonoscopy was performed in the control group directly.
Experimental: model-based interference group; Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score<3 in IM group colonoscopy directly.	Drug: Polyethylene glycol; Before colonoscopy, patient-related and procedure-related parameters were collected by one investigator in each center. In MI group, a procedure-based score, used for predicting inadequate bowel preparation, was calculated for each patients. Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score<3 in IM group and those in the control group underwent colonoscopy directly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate bowel preparation	Defined by each segmental BBPS≥2	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	The proportion of participants with at least one adenoma in each group	6 months
Overall complication related to bowel preparation		6 months

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Study Chair: Yanglin Pan, M.D, Air Force Military Medical University, China

Publications and helpful links

General Publications

• 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.
• 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.
• 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): June 14, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: June 14, 2020
• First Submitted That Met QC Criteria: June 14, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: colonoscopy; bowel preparation; factors
• Other Study ID Numbers: KY20200614-3

Drug and device information, study documents

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