Validation of a Prediction Model for Inadequate Bowel Preparation

NCT ID: NCT06438237

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2024-12-30

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

The primary outcome is quality of bowel preparation. The secondary outcomes include polyp/adenoma detection rate, willingness of undergoing colonoscopy again and adverse events.

Conditions

Bowel Preparation; Colonoscopy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Patients undergoing colonoscopy in General Hospital of Northern Theater Command

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.

Bowel preparation before colonoscopy

Intervention Type: PROCEDURE

Patients use purgative for bowel cleansing before colonoscopy.

Patients undergoing colonoscopy in First Affiliated Hospital of China Medical University

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 2 L PEG regimen was used for all patients.

Bowel preparation before colonoscopy

Intervention Type: PROCEDURE

Patients use purgative for bowel cleansing before colonoscopy.

Inpatients undergoing colonoscopy in Second Affiliated Hospital of Army Medical University

We retrospectively collect data of inpatients 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 full-dose 3 L PEG regimen was used for all patients.

Bowel preparation before colonoscopy

Intervention Type: PROCEDURE

Patients use purgative for bowel cleansing before colonoscopy.

Patients undergoing colonoscopy in No. 960 Hospital

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. Split-dose 3 L PEG, sodium phosphate or sodium picosulfate regimen were used according to the doctor's advice.

Bowel preparation before colonoscopy

Intervention Type: PROCEDURE

Patients use purgative for bowel cleansing before colonoscopy.

Interventions

Bowel preparation before colonoscopy

Patients use purgative for bowel cleansing before colonoscopy.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 94 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Xingshun Qi

Director of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xingshun Qi

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, General Hospital of Northern Theater Command

Locations

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 19136102 (View on PubMed)

Other Identifiers

V-PMIBP

Identifier Type: -

Identifier Source: org_study_id