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

• Sponsor: Air Force Military Medical University, China (Other)
• Overall Status: Completed
• CT.gov ID: NCT04101097
• Collaborator: Shenzhen Hospital of Southern Medical University (Other), Xiamen Hongai Hospital (Other), Huaihe Hospital of Henan University (Other), Shaanxi Second People's Hospital (Other)
• Enrollment: 900
• Locations: 5
• Actual Duration (Months): 6.9
• Patients Per Site: 180
• Patients Per Site Per Month: 26.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colonoscopy; Bowel Preparation; Predictive Model

Study Design

• Study Type: Observational
• Actual Enrollment: 900 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Training and Validation of Models Based on Patient-related or Procedure-related Factors to Predict Inadequate Bowel Preparation in Patients Undergoing Colonoscopy
• Actual Study Start Date: Sep 3, 2019
• Actual Primary Completion Date: Mar 30, 2020
• Actual Study Completion Date: Mar 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
training group All patients received oral and written instructions on the appointment day. All patients were instructed to have low-residue food for lunch and dinner on the day before colonoscopy. Patients were instructed to begin drinking the first 1.5L-2L PEG at 7:00-9:00 PM on the day before colonoscopy. On the day of the procedure, they took another 1.5L-2L 4-6 hours before colonoscopy. Patients were encouraged more to drink more clear liquids after purgatives for adequate hydration.
validation group All patients received oral and written instructions on the appointment day. All patients were instructed to have low-residue food for lunch and dinner on the day before colonoscopy. Patients were instructed to begin drinking the first 1.5L-2L PEG at 7:00-9:00 PM on the day before colonoscopy. On the day of the procedure, they took another 1.5L-2L 4-6 hours before colonoscopy. Patients were encouraged more to drink more clear liquids after purgatives for adequate hydration.

Outcome Measures

Primary Outcome Measures

1. Inadequate bowel preparation [1 hour]

   Inadequate bowel preparation was defined by the Boston Bowel Preparation Scale of any segmental<2.

Secondary Outcome Measures

1. Adequacy of proximal bowel preparation [1 hour]

   Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of right-colon<2 or middle colon<2

2. Adequacy of distal bowel preparation [1 hour]

   Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of left-colon<2 or middle colon<2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, Hongai Hospital	Xiamen	Fujian	China	361000
2	Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University	Shenzhen	Guangdong	China	510000
3	Department of Gastroenterology, Huaihe Hospital of Henan University	Kaifeng	Henan	China	475000
4	Department of Gastroenterology, Shaanxi Second People's Hospital	Xi'an	Shaanxi	China	710005
5	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi	China	710032

Sponsors and Collaborators

• Air Force Military Medical University, China
• Shenzhen Hospital of Southern Medical University
• Xiamen Hongai Hospital
• Huaihe Hospital of Henan University
• Shaanxi Second People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yanglin Pan, Associate Professor, Air Force Military Medical University, China
• ClinicalTrials.gov Identifier: NCT04101097
• Other Study ID Numbers: KY20190903-3
• First Posted: Sep 24, 2019
• Last Update Posted: Jun 16, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yanglin Pan, Associate Professor, Air Force Military Medical University, China: factors;bowel preparation;colonoscopy

Study Results

No Results Posted as of Jun 16, 2020