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Risk Factors for Inadequate Bowel Preparation in Patients With Chronic Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842411
Recruitment Status : Unknown
Verified August 2016 by Yanglin Pan, Air Force Military Medical University, China.
Recruitment status was:  Recruiting
First Posted : July 22, 2016
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Air Force Military Medical University, China

Brief 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. 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.

Condition or disease
Constipation

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : August 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Group/Cohort
chronic constipation
patients with chronic constipation based on Rome Ⅳ



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. polyp detection rate [ Time Frame: 6 months ]
  2. insertion time [ Time Frame: 6 months ]
  3. withdrawal time [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients >=18 years old undergoing colonoscopy
Criteria

Inclusion Criteria:

  • 18-90
  • Patients undergoing colonoscopy;
  • Patients meeting the criteria of chronic constipation of Rome Ⅳ;

Exclusion Criteria:

  • history of colorectal surgery;
  • known of suspected colonic stricture or obstructing tumour;
  • ulcerative colitis;
  • Crohn's disease;
  • irritable bowel syndrome;
  • toxic colitis or megacolon;
  • known or suspected bowel obstruction or perforation;
  • pregnancy or lactation;
  • unable to give informed consent;
  • haemodynamically unstable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842411


Contacts
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Contact: Yanglin Pan, MD +862984771536 yanglinpan@hotmail.com

Locations
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China, Shaanxi
The Second Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710004
Contact: Shiyang Ma, MD    +862984771536    shiyangma@163.com   
Xijing Hospital of Digestive Diseases Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Xiaoyang Guo, M.D.    +862984771536    xiaoyang_guo@163.com   
Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710038
Contact: Mingxin Zhang, MD    +862984771536    zmx3115@163.com   
Chinese PLA 451 Hospital Recruiting
Xi'an, Shaanxi, China, 710054
Contact: Yujie Jing, MD    +862984771536    guoxiaoyang3305@163.com   
Sponsors and Collaborators
Air Force Military Medical University, China
Investigators
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Principal Investigator: Yanglin Pan, MD Xijing Hospital of Digestive Disease
Principal Investigator: Mingxin Zhang, MD Tang-Du Hospital
Principal Investigator: Shiyang Ma, MD Second Affiliated Hospital of Xi'an Jiaotong University
Principal Investigator: Yujie Jing, MD Chinese PLA 451 Hospital
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yanglin Pan, Associated professor, Air Force Military Medical University, China
ClinicalTrials.gov Identifier: NCT02842411    
Other Study ID Numbers: 20160616-5
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yanglin Pan, Air Force Military Medical University, China:
bowel preparation
chronic constipation
risk factor
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive