Bowel PreparationNCT06438237

Validation of a Prediction Model for Inadequate Bowel Preparation

An observational study of Bowel Preparation and Colonoscopy, run by General Hospital of Shenyang Military Region at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 94 yearsHealthy volunteers can take part
Conditions the study is for: Bowel Preparation, Colonoscopy
What is being tested?: Bowel preparation before colonoscopy
Type of treatment: Surgery or procedure
How many people: 2,360 participants
Where: 1 siteChina
Study dates: 6 May 2024to 30 Dec 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 94 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Adult patients undergoing colonoscopy

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, 110840

Other trials in China

About this study

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

Read the 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
Being tested: Bowel preparation before colonoscopy
Keywords: Bowel preparation for colonoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bowel preparation before colonoscopyProcedure or surgery
Patients use purgative for bowel cleansing before colonoscopy.

Study groups in NCT06438237
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Bowel preparation before colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: During the procedure of colonoscopy

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 May 202430 Dec 2024

First posted31 May 2024
Study start6 May 2024
Primary completion30 Dec 2024
Study completion30 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Bowel PreparationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 2,360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06438237
Sponsor's protocol ID: V-PMIBP
Status last verified: May 2024
First submitted: 27 May 2024
Last updated: 1 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 19136102
Wang W, Tong L, Li S, He W, Huang J, Liu X, Wang C, Xia J, Qi X, Song C. Development and multicenter external validation of a novel prediction model for inadequate bowel preparation before colonoscopy. BMC Med Inform Decis Mak. 2026 Jan 23;26(1):46. doi: 10.1186/s12911-026-03348-w.
PubMed 41578308

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Not yet recruiting
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer, Rectal Adenocarcinoma
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula

All Bowel Preparation trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of a Prediction Model for Inadequate Bowel Preparation Before Colonoscopy Based on a Systematic Review and Meta-analysis
ClinicalTrials.gov ID: NCT06438237
Acronym / sponsor ID: V-PMIBP
Conditions: Bowel Preparation, Colonoscopy
Keywords: Bowel preparation for colonoscopy
Study type: Observational
Recruitment status: Completed
Enrolment: 2,360 participants (actual)
Lead sponsor: General Hospital of Shenyang Military RegionUniversity, hospital or other
Study start: 6 May 2024 (actual)
Primary completion: 30 Dec 2024 (actual)
Study completion: 30 Dec 2024 (actual)
First posted: 31 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 4

Arm	Type	Receives
Patients undergoing colonoscopy in General Hospital of Northern Theater Command	–	Procedure: Bowel preparation before colonoscopyPatients 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.
Patients undergoing colonoscopy in First Affiliated Hospital of China Medical University	–	Procedure: Bowel preparation before colonoscopyPatients 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.
Inpatients undergoing colonoscopy in Second Affiliated Hospital of Army Medical University	–	Procedure: Bowel preparation before colonoscopyWe 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.
Patients undergoing colonoscopy in No. 960 Hospital	–	Procedure: Bowel preparation before colonoscopyPatients 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.

Who may qualify

Ages: 18 to 94 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Adult patients undergoing colonoscopy

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bowel preparation before colonoscopyPatients use purgative for bowel cleansing before colonoscopy.	Procedure or surgery	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

Primary outcome

Quality of bowel preparation
Time frame: 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.

3 secondary outcomes

Adenoma and/or polyp detection rate
Time frame: During the procedure of colonoscopy
Number of polyps and/or adenomas
Time frame: During the procedure of colonoscopy
Adverse events
Time frame: Before the procedure of colonoscopy

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
Background: PubMed 19136102Lai 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.
Derived from this study: PubMed 41578308Wang W, Tong L, Li S, He W, Huang J, Liu X, Wang C, Xia J, Qi X, Song C. Development and multicenter external validation of a novel prediction model for inadequate bowel preparation before colonoscopy. BMC Med Inform Decis Mak. 2026 Jan 23;26(1):46. doi: 10.1186/s12911-026-03348-w.
Individual participant dataSharing planned: No

Related trials for Bowel Preparation

RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Not yet recruiting
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer, Rectal Adenocarcinoma
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xingshun Qi principal investigator

Department of Gastroenterology, General Hospital of Northern Theater Command

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bowel Preparation and Colonoscopy, run by General Hospital of Shenyang Military Region at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of bowel preparation (time frame: During the procedure of colonoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06438237, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.