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

NCT ID: NCT04101097

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-03

Study Completion Date

2020-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colonoscopy Bowel Preparation Predictive Model

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Interventions

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Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen Hospital of Southern Medical University

OTHER

Sponsor Role collaborator

Xiamen Humanity Hospital

OTHER

Sponsor Role collaborator

Huaihe Hospital of Henan University

OTHER

Sponsor Role collaborator

Shaanxi Second People's Hospital

UNKNOWN

Sponsor Role collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Gastroenterology, Hongai Hospital

Xiamen, Fujian, China

Site Status

Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, China

Site Status

Department of Gastroenterology, Huaihe Hospital of Henan University

Kaifeng, Henan, China

Site Status

Department of Gastroenterology, Shaanxi Second People's Hospital

Xi'an, Shaanxi, China

Site Status

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 22239959 (View on PubMed)

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.

Reference Type RESULT
PMID: 25600879 (View on PubMed)

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.

Reference Type RESULT
PMID: 28282690 (View on PubMed)

Other Identifiers

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KY20190903-3

Identifier Type: -

Identifier Source: org_study_id

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