Colonoscopy Clinical Trial
Official title:
The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors: a Multicenter, Randomized Controlled Study
Verified date | September 2021 |
Source | Air Force Military Medical University, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 900 |
Est. completion date | March 1, 2021 |
Est. primary completion date | February 28, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Gastroenterology, Huaihe Hospital of Henan University | Kaifeng | Henan |
China | Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University | Shenzhen | Guangdong |
China | Department of Gastroenterology, Shaanxi Second People's Hospital | Xi'an | Shaanxi |
China | Endoscopic center, Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi |
China | Department of Gastroenterology, Hongai Hospital | Xiamen | Fujian |
Lead Sponsor | Collaborator |
---|---|
Air Force Military Medical University, China |
China,
Dik VK, Moons LM, Hüyük M, van der Schaar P, de Vos Tot Nederveen Cappel WH, Ter Borg PC, Meijssen MA, Ouwendijk RJ, Le Fèvre DM, Stouten M, van der Galiën 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. — View Citation
Gimeno-García AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Pérez CD, Nicolás-Pérez D, Alarcon-Fernández O, Jiménez 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adequate bowel preparation | Defined by each segmental BBPS=2 | 6 months | |
Secondary | Adenoma detection rate | The proportion of participants with at least one adenoma in each group | 6 months | |
Secondary | Overall complication related to bowel preparation | 6 months |
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