Validation of a Prediction Model for Inadequate Bowel Preparation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colonoscopy; Bowel Preparation
• Intervention / Treatment: Procedure: Bowel preparation before colonoscopy

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 615

Contacts and Locations

• Study Contact: Name: Xingshun Qi; Phone Number: 18909881019; Email: xingshunqi@126.com
• Study Contact Backup: Name: Weiyi Wang; Phone Number: 13019441024; Email: 373302698@qq.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110840
      • Recruiting
      • Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
      • Contact: Xingshun Qi; Phone Number: 18909881019; Email: xingshunqi@126.com
      • Contact: Weiyiy Wang; Phone Number: 13019441024; Email: 373302698@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing colonoscopy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing colonoscopy; Patients were informed to eat semi-liquid and non-slag diet for breakfast and lunch and full-liquid diet for dinner on the day before colonoscopy, and be fasting on the day of colonoscopy. A split-dose 3 L PEG regimen was used for all patients.	Procedure: Bowel preparation before colonoscopy; Patients use purgative for bowel cleansing before colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of polyps and/or adenomas	Number of polyps and/or adenomas detected during colonoscopy	During the procedure of colonoscopy
Adverse events	Incidence of abdominal pain, bloating, nausea/vomiting after intake of PEG.	Before the procedure of colonoscopy

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region
• Investigators: Principal Investigator: Xingshun Qi, Department of Gastroenterology, General Hospital of Northern Theater Command

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: May 27, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Bowel preparation for colonoscopy
• Other Study ID Numbers: V-PMIBP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No