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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04434625
Other study ID # KY20200614-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 14, 2020
Est. completion date March 1, 2021

Study information

Verified date September 2021
Source Air Force Military Medical University, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (3)

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

Outcome

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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