External Validation of a Predictive Model for Bowel Preparation in Patients Undergoing Colonoscopy
1 other identifier
observational
600
1 country
12
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Shorter than P25 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 23, 2020
CompletedFirst Submitted
Initial submission to the registry
March 26, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJuly 28, 2020
July 1, 2020
2 months
March 26, 2020
July 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Adequate bowel preparation
Defined by each segmental BBPS≥2
1 hour
Secondary Outcomes (1)
The rate of yellow, clear stool in the last defecation
1 hour
Interventions
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.
Eligibility Criteria
This is a prospective study involving eleven tertiary-centers in China.
You may qualify if:
- Age≥18
- Patient undergoing colonoscopy
You may not qualify if:
- Patients with prior colectomy
- Unable to provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Department of Gastroenterology, Hongai Hospital
Xiamen, Fujian, 361000, China
Xiang'an hospital of Xiamen University
Xiamen, Fujian, China
Department of Gastroenterology, Qionghai people's hospital
Qionghai, Hainan, China
Department of Gastroenterology, Bethune international peace hospital
Shijiazhuang, Hebei, China
Department of Gastroenterology，Zhengzhou Central Hospital
Zhengzhou, Henan, China
Department of Gastroenterology, Shaanxi Second People's Hospital
Xi'an, Shaanxi, 710005, China
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Medical University
Xi'an, Shannxi, China
Department of Gastroenterology，Shanxi Bethune hospital
Taiyuan, Shanxi, China
Department of Gastroenterology，Chengdu third people's hospital
Chengdu, Sichuang, China
Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University
Shihezi, Xinjiang, 832008, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 7 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated professor
Study Record Dates
First Submitted
March 26, 2020
First Posted
March 27, 2020
Study Start
March 23, 2020
Primary Completion
May 30, 2020
Study Completion
June 30, 2020
Last Updated
July 28, 2020
Record last verified: 2020-07