CClinicalTrials.gg
CompletedNCT04101097Updated Jun 16, 2020

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

An observational study in Colonoscopy, Bowel Preparation and Predictive Model, sponsored by Air Force Military Medical University, China. Completed at 5 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Air Force Military Medical University, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
900
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Colonoscopy
  • Bowel Preparation
  • Predictive Model

Keywords

  • factors;bowel preparation;colonoscopy
03

In context

Lead sponsor

Air Force Military Medical University, China is the lead sponsor of 172 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Using PEG for bowel preparation before colonoscopy

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
900 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Inadequate bowel preparation

    Inadequate bowel preparation was defined by the Boston Bowel Preparation Scale of any segmental\<2.

    Time frame: 1 hour

Secondary outcomes

  1. Adequacy of proximal bowel preparation

    Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of right-colon\<2 or middle colon\<2

    Time frame: 1 hour

  2. Adequacy of distal bowel preparation

    Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of left-colon\<2 or middle colon\<2

    Time frame: 1 hour

07

Study locations

5 sites
  • Department of Gastroenterology, Hongai Hospital
    Xiamen, Fujian 361000, China
  • Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University
    Shenzhen, Guangdong 510000, China
  • Department of Gastroenterology, Huaihe Hospital of Henan University
    Kaifeng, Henan 475000, China
  • Department of Gastroenterology, Shaanxi Second People's Hospital
    Xi'an, Shaanxi 710005, China
  • Endoscopic center, Xijing Hospital of Digestive Diseases
    Xi'an, Shaanxi 710032, China
08

References and documents

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. PubMed 22239959 ↗
  • 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. PubMed 25600879 ↗
  • 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. PubMed 28282690 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04101097
Lead sponsor
Air Force Military Medical University, China
Collaborators
Shenzhen Hospital of Southern Medical University, Xiamen Humanity Hospital, Huaihe Hospital of Henan University, Shaanxi Second People's Hospital
Responsible party
Yanglin Pan (Associate Professor, Air Force Military Medical University, China) — Principal investigator
First posted
Sep 24, 2019
Start date
Sep 3, 2019
Primary completion
Mar 30, 2020
Completion
Mar 30, 2020
Last update
Jun 16, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion