Validation of a Prediction Model for Inadequate Bowel Preparation

NCT06438237 | Completed

• 1 other identifier: V-PMIBP
• Study Type: observational
• Target: 2,360
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation; Colonoscopy

Keywords

Bowel preparation for colonoscopy

Outcome Measures

Primary Outcomes (1)

• Quality of bowel preparation

  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.

  During the procedure of colonoscopy

Secondary Outcomes (3)

• Adenoma and/or polyp detection rate

  During the procedure of colonoscopy

• Number of polyps and/or adenomas

  During the procedure of colonoscopy

• Adverse events

  Before the procedure of colonoscopy

Study Arms (4)

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.

Procedure: Bowel preparation 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.

Procedure: Bowel preparation 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.

Procedure: Bowel preparation 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.

Procedure: Bowel preparation before colonoscopy

Interventions

Bowel preparation before colonoscopy PROCEDURE

Patients use purgative for bowel cleansing before colonoscopy.

Inpatients undergoing colonoscopy in Second Affiliated Hospital of Army Medical University; Patients undergoing colonoscopy in First Affiliated Hospital of China Medical University; Patients undergoing colonoscopy in General Hospital of Northern Theater Command; Patients undergoing colonoscopy in No. 960 Hospital

Eligibility Criteria

• Age: 18 Years - 94 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing colonoscopy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

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

Shenyang, Liaoning, 110840, China

Location

Related 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.

  PMID: 19136102 BACKGROUND

Study Officials

• Xingshun Qi

  Department of Gastroenterology, General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: May 31, 2024
• Study Start: May 6, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 1, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)