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A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Diseases

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Polyethylene Glycols
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammatory Bowel Diseases focused on measuring modified bowel preparation method, inflammatory bowel disease, risk factors, quality of bowel preparation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis: inflammatory bowel disease (IBD) patients, including ulcerative colitis (UC) and Crohn's disease (CD), have colonic involvement.
  • Patients and/or family members can understand the study protocol and are willing to participate in the study and provide informed consent in writing.

Exclusion Criteria:

  • The diagnosis is not definite.
  • Toxic megacolon, gastrointestinal perforation or other acute abdominal diseases; Patients with gastrointestinal bleeding with unstable vital signs.
  • Patients after colon surgery.
  • Serious underlying diseases, organ failure, or inability to cooperate with colonoscopy for other reasons.
  • Patients can not cooperate with the use of polyethylene glycol or glycerin enema.
  • Patients or family members cannot understand the conditions and objectives of this study.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting
  • Heilongjiang Provincial Hospital
  • The First Affiliated Hospital of Soochow University
  • The first Hospital of China Medical University
  • Beijing Rectum Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified bowel preparation method group

Traditional bowel preparation method group

Arm Description

One day before the colonoscopy, only asol (or other intestinal nutrient solution) was taken. On the examination day (4 hours before), 1 bag of polyethylene glycol solution + (2 hours before) glycerin enema 110ml was taken

Low residue diet 2 days before the colonoscopy, take 2 bags of polyethylene glycol solution the night before the examination and 1 bag of which on the examination day (4 hours before)

Outcomes

Primary Outcome Measures

The quality of bowel preparation evaluated by endoscopists during colonoscopy.
The quality of bowel preparation will be evaluated with the Boston bowel preparation scale (BBPS), including the total Boston score (range 0-9, score 8-9 means excellent, 7 means good, less than 7 means bad) and score of per bowel segment (maximum 3).
Number of Participants with increased Disease activity after colonoscopy.
Disease activity will be assessed using C-reactive protein (CRP) measurement, the modified Mayo score in ulcerative colitis and the Crohn's Disease Activity Index score in Crohn's Disease. If the result after colonoscopy was higher than before, the participant may be considered with increased disease activity.

Secondary Outcome Measures

Tolerance score of participants after bowel preparation.
Tolerance score is defined range 0-10 (0 means totally intolerant, 10 means feel really good).
Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease after colonoscopy.
Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease within 30 days after colonoscopy.
Number of Participants hospitalized because of aggravation of disease after colonoscopy.
Number of Participants who is hospitalized because of aggravation of disease within 30 days after colonoscopy.

Full Information

First Posted
July 5, 2022
Last Updated
May 22, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05485103
Brief Title
A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease
Official Title
A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of modified colonoscopy bowel preparation method compared with traditional method on bowel cleansing effect, colonoscopy examination effect and clinical condition of inflammatory bowel disease patients. Risk factors affecting the quality of bowel preparation will also be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
modified bowel preparation method, inflammatory bowel disease, risk factors, quality of bowel preparation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified bowel preparation method group
Arm Type
Experimental
Arm Description
One day before the colonoscopy, only asol (or other intestinal nutrient solution) was taken. On the examination day (4 hours before), 1 bag of polyethylene glycol solution + (2 hours before) glycerin enema 110ml was taken
Arm Title
Traditional bowel preparation method group
Arm Type
Active Comparator
Arm Description
Low residue diet 2 days before the colonoscopy, take 2 bags of polyethylene glycol solution the night before the examination and 1 bag of which on the examination day (4 hours before)
Intervention Type
Drug
Intervention Name(s)
Polyethylene Glycols
Other Intervention Name(s)
glycerin enema, asol
Intervention Description
Take asol as total enteral nutrition, and take polyethylene glycols and glycerin enema as bowel preparations
Primary Outcome Measure Information:
Title
The quality of bowel preparation evaluated by endoscopists during colonoscopy.
Description
The quality of bowel preparation will be evaluated with the Boston bowel preparation scale (BBPS), including the total Boston score (range 0-9, score 8-9 means excellent, 7 means good, less than 7 means bad) and score of per bowel segment (maximum 3).
Time Frame
During colonoscopy examination
Title
Number of Participants with increased Disease activity after colonoscopy.
Description
Disease activity will be assessed using C-reactive protein (CRP) measurement, the modified Mayo score in ulcerative colitis and the Crohn's Disease Activity Index score in Crohn's Disease. If the result after colonoscopy was higher than before, the participant may be considered with increased disease activity.
Time Frame
Within 7 days after colonoscopy
Secondary Outcome Measure Information:
Title
Tolerance score of participants after bowel preparation.
Description
Tolerance score is defined range 0-10 (0 means totally intolerant, 10 means feel really good).
Time Frame
After bowel preparation and before colonoscopy
Title
Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease after colonoscopy.
Description
Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease within 30 days after colonoscopy.
Time Frame
Within 30 days after colonoscopy
Title
Number of Participants hospitalized because of aggravation of disease after colonoscopy.
Description
Number of Participants who is hospitalized because of aggravation of disease within 30 days after colonoscopy.
Time Frame
Within 30 days after colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis: inflammatory bowel disease (IBD) patients, including ulcerative colitis (UC) and Crohn's disease (CD), have colonic involvement. Patients and/or family members can understand the study protocol and are willing to participate in the study and provide informed consent in writing. Exclusion Criteria: The diagnosis is not definite. Toxic megacolon, gastrointestinal perforation or other acute abdominal diseases; Patients with gastrointestinal bleeding with unstable vital signs. Patients after colon surgery. Serious underlying diseases, organ failure, or inability to cooperate with colonoscopy for other reasons. Patients can not cooperate with the use of polyethylene glycol or glycerin enema. Patients or family members cannot understand the conditions and objectives of this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Xu, MD
Phone
+86-010-69151591
Email
xuhui10799@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Yang, MD
Email
yangh@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Xu, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Xu, MD
Phone
+86-010-69151591
Email
xuhui10799@pumch.cn
First Name & Middle Initial & Last Name & Degree
Hui Xu, MD
Facility Name
Heilongjiang Provincial Hospital
City
Ha'erbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yue Yang
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanjun Chen
Facility Name
The first Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuying Xu
Facility Name
Beijing Rectum Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junmei Zhang

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease

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