The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors

Not Applicable

Completed

• Conditions: Colonoscopy; Predictive Model; Bowel Preparation
• Interventions: Drug: Polyethylene glycol

• Registration Number: NCT04434625
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadequate bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offered to achieve better bowel cleaning. Currently, there were three predicting models of inadequate bowel preparation established based on patient-related factors. So far, none of predictive models have been tested in other than their validation cohort populations, and no study has attempted to apply a different regimen to patients presenting with risk factors for inadequate colon cleanliness. In previous studies, we established a prediction model based on procedure-related factors, which has better accuracy and can better predict the quality of bowel preparation.

The aim of this study is to compare the quality of bowel preparation by using a predictive model based on procedure-related factors versus the criterion group in unsedation patients

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-14
• Study First Submitted: 2020-06-14
• Study First Submitted QC: 2020-06-14
• Study First Posted: 2020-06-17
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Age: 18~75 years
• Patients undergoing morning colonoscopy

Exclusion Criteria

• colon resection;
• suspected bowel obstruction;
• moderate or severe complications related to drinking the 1st or 2rd dose of PEG
• hemodynamically unstable;
• lactating or pregnant women;
• no need to reach the ileocecal segment
• unwilling to provided informed content.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
model-based interference group	Polyethylene glycol	Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score\<3 in IM group colonoscopy directly.

Primary Outcome Measures

Name	Time	Method
Adequate bowel preparation	6 months	Defined by each segmental BBPS≥2

Secondary Outcome Measures

Name	Time	Method
Overall complication related to bowel preparation	6 months
Adenoma detection rate	6 months	The proportion of participants with at least one adenoma in each group

Trial Locations

Locations (5)

Department of Gastroenterology, Hongai Hospital; 🇨🇳 Xiamen, Fujian, 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