## Protocol Section
### Identification Module
**NCT ID:** NCT06438237

**Brief Title:** Validation of a Prediction Model for Inadequate Bowel Preparation

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

#### Organization Study ID Info
**ID:** V-PMIBP
#### Organization
**Class:** OTHER
**Full Name:** General Hospital of Shenyang Military Region
### Status Module
#### Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-06

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** General Hospital of Shenyang Military Region

#### Responsible Party

**Investigator Affiliation:** General Hospital of Shenyang Military Region

**Investigator Full Name:** Xingshun Qi

**Investigator Title:** Director of Gastroenterology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

**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.

### Conditions Module

**Conditions:**

- Bowel Preparation

- Colonoscopy

**Keywords:**

- Bowel preparation for colonoscopy

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 615

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: Bowel preparation before colonoscopy

**Label:** Patients undergoing colonoscopy

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients undergoing colonoscopy

**Description:** Patients use purgative for bowel cleansing before colonoscopy.

**Name:** Bowel preparation before colonoscopy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** A total BBPS score ≥6 with BBPS score ≥2 for each colon segment was considered to have adequate bowel preparation.

**Measure:** Quality of bowel preparation

**Time Frame:** During the procedure of colonoscopy

#### Secondary Outcomes

**Description:** Proportion of patients with at least one adenoma and/or polyp detected during colonoscopy

**Measure:** Adenoma and/or polyp detection rate

**Time Frame:** During the procedure of colonoscopy

**Description:** Number of polyps and/or adenomas detected during colonoscopy

**Measure:** Number of polyps and/or adenomas

**Time Frame:** During the procedure of colonoscopy

**Description:** Incidence of abdominal pain, bloating, nausea/vomiting after intake of PEG.

**Measure:** Adverse events

**Time Frame:** Before the procedure of colonoscopy

### Eligibility Module

**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. patients previously enrolled in this study.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult patients undergoing colonoscopy

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** xingshunqi@126.com

**Name:** Xingshun Qi

**Phone:** 18909881019

**Role:** CONTACT

**Contact 2:**

**Email:** 373302698@qq.com

**Name:** Weiyi Wang

**Phone:** 13019441024

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shenyang

**Contacts:**

***Contact 1:***

- **Email:** xingshunqi@126.com

- **Name:** Xingshun Qi

- **Phone:** 18909881019

- **Role:** CONTACT

***Contact 2:***

- **Email:** 373302698@qq.com

- **Name:** Weiyiy Wang

- **Phone:** 13019441024

- **Role:** CONTACT

**Country:** China

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

**State:** Liaoning

**Status:** RECRUITING

**Zip:** 110840

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Gastroenterology, General Hospital of Northern Theater Command

**Name:** Xingshun Qi

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M27664

- Name: Laxatives

- Relevance: LOW

- As Found: Unknown

- ID: M5651

- Name: Cathartics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
