External Validation of a Predictive Model for Bowel Preparation in Patients Undergoing Colonoscopy

Colonoscopy Clinical Trial

Official title:

External Validation of a Predictive Model for Bowel Preparation in Patients Undergoing Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325139
• Other study ID #: KT20200324-3
• Status: Completed
• Start date: March 23, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Bowel preparation is closely lined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies. This study aimed to externally validate the efficiency of a procedure-based model in predicting inadequate bowel preparation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age=18

• Patient undergoing colonoscopy

Exclusion Criteria:

• Patients with prior colectomy

• Unable to provide written informed consent

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy

Intervention

Other:
• Questionnaire
Before colonoscopy, the following information was obtained by the colonoscopists through asking patients: the characteristics of last stool, the time of drinking first dose of laxative, the time of first defecation, the time of drinking last dose of laxative. The beginning time of colonoscopy was also recorded. During withdrawal phase, the quality of bowel preparation was evaluated based on BBPS scale.

Locations

Country	Name	City	State
China	Department of Gastroenterology,Chengdu third people's hospital	Chengdu	Sichuang
China	Department of Gastroenterology, Qionghai people's hospital	Qionghai	Hainan
China	Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University	Shihezi	Xinjiang
China	Department of Gastroenterology, Bethune international peace hospital	Shijiazhuang	Hebei
China	Department of Gastroenterology,Shanxi Bethune hospital	Taiyuan	Shanxi
China	Department of Gastroenterology, Shaanxi Second People's Hospital	Xi'an	Shaanxi
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xi'an Medical University	Xi'an	Shannxi
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Department of Gastroenterology, Hongai Hospital	Xiamen	Fujian
China	Xiang'an hospital of Xiamen University	Xiamen	Fujian
China	Department of Gastroenterology,Zhengzhou Central Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate bowel preparation	Defined by each segmental BBPS=2	1 hour
Secondary	The rate of yellow, clear stool in the last defecation	The characteristics of the last stool was self-evaluated by patients based on a picture containing different kind of stool examples.	1 hour