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

NCT ID: NCT04434625

Last Updated: 2021-09-14

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

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-14

Study Completion Date

2021-03-01

Brief Summary

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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

Detailed Description

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Conditions

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Colonoscopy Bowel Preparation Predictive Model

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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control group

Colonoscopy was performed in the control group directly.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Polyethylene glycol

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanglin Pan, M.D

Role: STUDY_CHAIR

Air Force Military Medical University, China

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 BACKGROUND
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 BACKGROUND
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 BACKGROUND
PMID: 28282690 (View on PubMed)

Chen L, Kang X, Ren G, Luo H, Zhang L, Wang L, Zhao J, Zhang R, Zhang X, Zhao L, Pan Y. Individualized intervention based on a preparation-related prediction model improves adequacy of bowel preparation: A prospective, multi-center, randomized, controlled study. Dig Liver Dis. 2024 Mar;56(3):436-443. doi: 10.1016/j.dld.2023.09.001. Epub 2023 Sep 19.

Reference Type DERIVED
PMID: 37735023 (View on PubMed)

Other Identifiers

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KY20200614-3

Identifier Type: -

Identifier Source: org_study_id

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