Validation of a Prediction Model for Inadequate Bowel Preparation

Completed

• Conditions: Bowel Preparation; Colonoscopy

• Registration Number: NCT06438237
• Lead Sponsor: General Hospital of Shenyang Military Region

Brief Summary

We have developed a novel inadequate bowel preparation prediction model based on a systematic review and meta-analysis. The goal of this multicenter observational study is to validate the accuracy of this model.

Detailed Description

A total of 2208 patients undergoing colonoscopy will be enrolled. The primary outcome is quality of bowel preparation. The secondary outcomes include polyp/adenoma detection rate, willingness of undergoing colonoscopy again and adverse events.

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-06
• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-05-27
• Study First Posted: 2024-05-31
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Last Update Submitted: 2025-06-21
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2360

Inclusion Criteria

1. adult patients (age is ≥18 years old);
2. patients undergoing colonoscopy;
3. written informed consent.

Exclusion Criteria

1. patients undergoing emergent colonoscopy;
2. patients with major psychiatric disorders;
3. pregnant or breast feeding patients;
4. patients with contraindications for colonoscopy (e.g., heart failure, renal insufficiency);
5. patients suspected to have intestinal obstruction, stenosis or perforation;
6. poor compliance with the bowel preparation protocol (poor compliance is indicated if the dose of medication was < 75% of the prescribed dose;
7. incomplete colonoscopy because of other circumstances apart from inadequate cleansing
8. patients previously enrolled in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of bowel preparation	During the procedure of colonoscopy	A total BBPS score ≥6 with BBPS score ≥2 for each colon segment was considered to have adequate bowel preparation. Each segment of the colon is scored from 0 to 3, with higher scores indicating superior cleansing, and summed for a total score that can range from 0 to 9.

Secondary Outcome Measures

Name	Time	Method
Adenoma and/or polyp detection rate	During the procedure of colonoscopy	Proportion of patients with at least one adenoma and/or polyp detected during colonoscopy
Number of polyps and/or adenomas	During the procedure of colonoscopy	Number of polyps and/or adenomas detected during colonoscopy
Adverse events	Before the procedure of colonoscopy	Incidence of abdominal pain, bloating, nausea/vomiting after intake of purgative.

Trial Locations

Locations (1)

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area); 🇨🇳 Shenyang, Liaoning, China