Bowel PreparationNCT04325139
External Validation of a Predictive Model for Bowel Preparation in Patients Undergoing Colonoscopy
An observational study of Bowel Preparation and Colonoscopy, run by Air Force Military Medical University, China at 12 sites in China.
Trial summary
Bowel preparation is closely lined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation, Colonoscopy
- What is being tested?
- Questionnaire
- How many people
- 600 participants
- Where
- 12 sitesChina
- Study dates
- 23 Mar 2020to 30 Jun 2020
- How long will I take part?
- 7 Days
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a prospective study involving eleven tertiary-centers in China.
Who may be able to join
- Age≥18
- Patient undergoing colonoscopy
Who cannot join
- Patients with prior colectomy
- Unable to provide written informed consent
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Department of Gastroenterology，Chengdu third people's hospital
Chengdu, Sichuang
Department of Gastroenterology, Qionghai people's hospital
Qionghai, Hainan
Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University
Shihezi, Xinjiang, 832008
Department of Gastroenterology, Bethune international peace hospital
Shijiazhuang, Hebei
Department of Gastroenterology，Shanxi Bethune hospital
Taiyuan, Shanxi
Department of Gastroenterology, Shaanxi Second People's Hospital
Xi'an, Shaanxi, 710005
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
The First Affiliated Hospital of Xi'an Medical University
Xi'an, Shannxi
Department of Gastroenterology, Hongai Hospital
Xiamen, Fujian, 361000
Xiang'an hospital of Xiamen University
Xiamen, Fujian
Department of Gastroenterology，Zhengzhou Central Hospital
Zhengzhou, Henan
About this study
Bowel preparation is closely lined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies. This study aimed to externally validate the efficiency of a procedure-based model in predicting inadequate bowel preparation
- Conditions
- Bowel Preparation, Colonoscopy
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Before colonoscopy, the following information was obtained by the colonoscopists through asking patients: the characteristics of last stool, the time of drinking first dose of laxative, the time of first defecation, the time of drinking last dose of laxative. The beginning time of colonoscopy was also recorded. During withdrawal phase, the quality of bowel preparation was evaluated based on BBPS scale.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate bowel preparation
Defined by each segmental BBPS≥2
Measured: 1 hour
Secondary outcomes (1)
The rate of yellow, clear stool in the last defecation
The characteristics of the last stool was self-evaluated by patients based on a picture containing different kind of stool examples.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start23 Mar 2020
- Primary completion30 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325139
- Sponsor's protocol ID
- KT20200324-3
- Status last verified
- Jul 2020
- First submitted
- 26 Mar 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of a Predictive Model for Bowel Preparation in Patients Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT04325139
- Acronym / sponsor ID
- KT20200324-3
- Conditions
- Bowel Preparation, Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 27 Mar 2020 (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.
Bowel preparation is closely lined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies. This study aimed to externally validate the efficiency of a procedure-based model in predicting inadequate bowel preparation
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective study involving eleven tertiary-centers in China.
Key inclusion criteria (2 listed)
- Age≥18
- Patient undergoing colonoscopy
Key exclusion criteria (2 listed)
- Patients with prior colectomy
- Unable to provide written informed consent
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 |
|---|---|---|
| QuestionnaireBefore colonoscopy, the following information was obtained by the colonoscopists through asking patients: the characteristics of last stool, the time of drinking first dose of laxative, the time of first defecation, the time of drinking last dose of laxative. The beginning time of colonoscopy was also recorded. During withdrawal phase, the quality of bowel preparation was evaluated based on BBPS scale. | Other | – |
Primary outcome
Adequate bowel preparation
Time frame: 1 hour
Defined by each segmental BBPS≥2
1 secondary outcome
The rate of yellow, clear stool in the last defecation
Time frame: 1 hour
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 28 Jul 2020.
Related trials for Bowel Preparation
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
RecruitingPhase 4
Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter)
Renal Failure Chronic Requiring Dialysis, Peritoneal Dialysis
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites 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 Air Force Military Medical University, China at 12 sites 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 2 inclusion and 2 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 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Adequate bowel preparation (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2020.