Clinical trial NCT04434625: The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors
Official title: The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors: a Multicenter, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Bowel Preparation
Predictive Model
Keywords: factors
bowel preparation
colonoscopy
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Adequate bowel preparation
timeFrame: 6 months
Secondary outcomes:
measure: Adenoma detection rate
timeFrame: 6 months
measure: Overall complication related to bowel preparation
timeFrame: 6 months
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:
affiliation: Air Force Military Medical University, China
name: Yanglin Pan, M.D
role: STUDY_CHAIR
References:
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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.