Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy

Colonoscopy Clinical Trial

Official title:

Training and Validation of Models Based on Patient-related or Procedure-related Factors to Predict Inadequate Bowel Preparation in Patients Undergoing Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04101097
• Other study ID #: KY20190903-3
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy
• Predictive Model

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