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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04101097
Other study ID # KY20190903-3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 3, 2019
Est. completion date March 30, 2020

Study information

Verified date June 2020
Source Fourth Military Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 900
Est. completion date March 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


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 (5)

Lead Sponsor Collaborator
Fourth Military Medical University Huaihe Hospital of Henan University, Shaanxi Second People's Hospital, Shenzhen Hospital of Southern Medical University, Xiamen Hongai Hospital

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. Predictin — 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 prepar — 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 identif — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Inadequate bowel preparation Inadequate bowel preparation was defined by the Boston Bowel Preparation Scale of any segmental<2. 1 hour
Secondary Adequacy of proximal bowel preparation Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of right-colon<2 or middle colon<2 1 hour
Secondary Adequacy of distal bowel preparation Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of left-colon<2 or middle colon<2 1 hour
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