ConstipationNCT02842411
Risk Factors for Inadequate Bowel Preparation in Patients With Chronic Constipation
An observational study of Constipation, run by Air Force Military Medical University, China at 4 sites in China.
Trial summary
Chronic constipation is one of the risk factors of inadequate bowel preparation, which could influence the effect of colonoscopy. The risk factors associated with inadequate bowel preparation in constipated patients remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- How many people
- 200 participants
- Where
- 4 sitesChina
- Study dates
- Aug 2016to Jan 2017
- 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: patients >=18 years old undergoing colonoscopy
Who may be able to join
- 18-90
- Patients undergoing colonoscopy;
- Patients meeting the criteria of chronic constipation of Rome Ⅳ;
Who cannot join
- history of colorectal surgery;
- known of suspected colonic stricture or obstructing tumour;
- ulcerative colitis;
- Crohn's disease;
- irritable bowel syndrome;
- toxic colitis or megacolon;
Show all 10Show fewer
- known or suspected bowel obstruction or perforation;
- pregnancy or lactation;
- unable to give informed consent;
- haemodynamically unstable.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
Shiyang Ma, MD, +862984771536, shiyangma@163.com
- Recruiting
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Xiaoyang Guo, M.D., +862984771536, xiaoyang_guo@163.com
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710038
Mingxin Zhang, MD, +862984771536, zmx3115@163.com
- Recruiting
Chinese PLA 451 Hospital
Xi'an, Shaanxi, 710054
Yujie Jing, MD, +862984771536, guoxiaoyang3305@163.com
About this study
Chronic constipation is one of the risk factors of inadequate bowel preparation, which could influence the effect of colonoscopy. The risk factors associated with inadequate bowel preparation in constipated patients remains unclear. Here the investigators investigated the high risk factors which might have influence on bowel preparation quality in a prospective cohort of patients with functional constipation.
- Conditions
- Constipation
- Keywords
- bowel preparation, chronic constipation, risk factor
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chronic constipation | patients with chronic constipation based on Rome Ⅳ |
What is being measured
The primary outcome is the main question the study is designed to answer.
adequate rate of bowel preparation ≥6 with each segment ≥2
The adequacy of bowel preparation is defined as Boston Bowel Preparation Scale (BBPS), a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. They were summed to give the total BBPS score, which ranged from 0 to 9.
Measured: 6 months
Secondary outcomes (3)
polyp detection rate
Measured: 6 months
insertion time
Measured: 6 months
withdrawal time
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
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
- Investigators
- Yanglin Pan, MD, Principal investigator, Xijing Hospital of Digestive DiseaseMingxin Zhang, MD, Principal investigator, Tang-Du HospitalShiyang Ma, MD, Principal investigator, Second Affiliated Hospital of Xi'an Jiaotong UniversityYujie Jing, MD, Principal investigator, Chinese PLA 451 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842411
- Sponsor's protocol ID
- 20160616-5
- Status last verified
- Aug 2016
- First submitted
- 25 Jun 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ness RM, Manam R, Hoen H, Chalasani N. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol. 2001 Jun;96(6):1797-802. doi: 10.1111/j.1572-0241.2001.03874.x.
PubMed 11419832Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.
PubMed 22239959Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011 Sep;106(9):1582-91; quiz 1581, 1592. doi: 10.1038/ajg.2011.164. Epub 2011 May 24.
PubMed 21606976Guo X, Shi X, Kang X, Luo H, Wang X, Jia H, Tao Q, Wang J, Zhang M, Wang J, Lu X, Ma S, Lin T, Jing Y, Pan Y, Guo X, Fan D. Risk Factors Associated with Inadequate Bowel Preparation in Patients with Functional Constipation. Dig Dis Sci. 2020 Apr;65(4):1082-1091. doi: 10.1007/s10620-019-05847-5. Epub 2019 Oct 12.
PubMed 31605278
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Inadequate Bowel Preparation in Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT02842411
- Acronym / sponsor ID
- 20160616-5
- Conditions
- Constipation
- Keywords
- bowel preparation, chronic constipation, risk factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 22 Jul 2016 (estimated)
- 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.
Chronic constipation is one of the risk factors of inadequate bowel preparation, which could influence the effect of colonoscopy. The risk factors associated with inadequate bowel preparation in constipated patients remains unclear. Here the investigators investigated the high risk factors which might have influence on bowel preparation quality in a prospective cohort of patients with functional constipation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic constipation | – | –patients with chronic constipation based on Rome Ⅳ |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients >=18 years old undergoing colonoscopy
Key inclusion criteria (3 listed)
- 18-90
- Patients undergoing colonoscopy;
- Patients meeting the criteria of chronic constipation of Rome Ⅳ;
Key exclusion criteria (10 listed)
- history of colorectal surgery;
- known of suspected colonic stricture or obstructing tumour;
- ulcerative colitis;
- Crohn's disease;
- irritable bowel syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
adequate rate of bowel preparation ≥6 with each segment ≥2
Time frame: 6 months
The adequacy of bowel preparation is defined as Boston Bowel Preparation Scale (BBPS), a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. They were summed to give the total BBPS score, which ranged from 0 to 9.
3 secondary outcomes
polyp detection rate
Time frame: 6 months
insertion time
Time frame: 6 months
withdrawal time
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Background: PubMed 11419832Ness RM, Manam R, Hoen H, Chalasani N. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol. 2001 Jun;96(6):1797-802. doi: 10.1111/j.1572-0241.2001.03874.x.
- Background: PubMed 22239959Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.
- Results publication: PubMed 21606976Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011 Sep;106(9):1582-91; quiz 1581, 1592. doi: 10.1038/ajg.2011.164. Epub 2011 May 24.
- Derived from this study: PubMed 31605278Guo X, Shi X, Kang X, Luo H, Wang X, Jia H, Tao Q, Wang J, Zhang M, Wang J, Lu X, Ma S, Lin T, Jing Y, Pan Y, Guo X, Fan D. Risk Factors Associated with Inadequate Bowel Preparation in Patients with Functional Constipation. Dig Dis Sci. 2020 Apr;65(4):1082-1091. doi: 10.1007/s10620-019-05847-5. Epub 2019 Oct 12.
- Individual participant dataSharing planned: Undecided
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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.
Yanglin Pan, MD principal investigator
Xijing Hospital of Digestive Disease
Mingxin Zhang, MD principal investigator
Tang-Du Hospital
Shiyang Ma, MD principal investigator
Second Affiliated Hospital of Xi'an Jiaotong University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by Air Force Military Medical University, China at 4 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanglin Pan, MD (+862984771536, yanglinpan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adequate rate of bowel preparation ≥6 with each segment ≥2 (time frame: 6 months). 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 NCT02842411, which also lists 4 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 Nov 2016.