Clinical trial NCT04101097: Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy
Official title: Training and Validation of Models Based on Patient-related or Procedure-related Factors to Predict Inadequate Bowel Preparation in Patients Undergoing Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Bowel Preparation
Predictive Model
Keywords: factors;bowel preparation;colonoscopy
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: Shenzhen Hospital of Southern Medical University
name: Xiamen Humanity Hospital
name: Huaihe Hospital of Henan University
name: Shaanxi Second People's Hospital
First posted: 2019-09-24
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Using PEG for bowel preparation before colonoscopy

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Inadequate bowel preparation
timeFrame: 1 hour
Secondary outcomes:
measure: Adequacy of proximal bowel preparation
timeFrame: 1 hour
measure: Adequacy of distal bowel preparation
timeFrame: 1 hour
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Department of Gastroenterology, Hongai Hospital
state: Fujian
city: Shenzhen
country: China
facility: Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University
state: Guangdong
city: Kaifeng
country: China
facility: Department of Gastroenterology, Huaihe Hospital of Henan University
state: Henan
city: Xi'an
country: China
facility: Department of Gastroenterology, Shaanxi Second People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.