The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors
NCT ID: NCT04434625
Last Updated: 2021-09-14
Study Results
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Basic Information
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COMPLETED
NA
900 participants
INTERVENTIONAL
2020-06-14
2021-03-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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control group
Colonoscopy was performed in the control group directly.
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.
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
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
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing morning colonoscopy
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Air Force Military Medical University, China
OTHER
Responsible Party
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Yanglin Pan
Associated professor
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
Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China
Department of Gastroenterology, Huaihe Hospital of Henan University
Kaifeng, Henan, China
Department of Gastroenterology, Shaanxi Second People's Hospital
Xi'an, Shaanxi, China
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China
Countries
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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.
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.
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.
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.
Other Identifiers
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KY20200614-3
Identifier Type: -
Identifier Source: org_study_id
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