Validation of a Prediction Model for Inadequate Bowel Preparation

Colonoscopy Clinical Trial

Official title:

Validation of a Prediction Model for Inadequate Bowel Preparation Before Colonoscopy Based on a Systematic Review and Meta-analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06438237
• Other study ID #: V-PMIBP
• Status: Recruiting
• Start date: May 6, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: General Hospital of Shenyang Military Region
• Contact: Xingshun Qi
• Phone: 18909881019
• Email: xingshunqi[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

A total of 615 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 615
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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. patients previously enrolled in this study.

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy

Intervention

Procedure:
• Bowel preparation before colonoscopy
Patients use purgative for bowel cleansing before colonoscopy.

Locations

Country	Name	City	State
China	Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

References & Publications (1)

Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of bowel preparation	A total BBPS score =6 with BBPS score =2 for each colon segment was considered to have adequate bowel preparation.	During the procedure of colonoscopy
Secondary	Adenoma and/or polyp detection rate	Proportion of patients with at least one adenoma and/or polyp detected during colonoscopy	During the procedure of colonoscopy
Secondary	Number of polyps and/or adenomas	Number of polyps and/or adenomas detected during colonoscopy	During the procedure of colonoscopy
Secondary	Adverse events	Incidence of abdominal pain, bloating, nausea/vomiting after intake of PEG.	Before the procedure of colonoscopy