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Defecation Postures for Functional Consumption

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ClinicalTrials.gov Identifier: NCT02772692
Recruitment Status : Unknown
Verified May 2016 by Zhanwei Zhao, Air Force Military Medical University, China.
Recruitment status was:  Not yet recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Zhanwei Zhao, Air Force Military Medical University, China

Tracking Information
First Submitted Date  ICMJE May 11, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
Frequency of defecation [ Time Frame: Six months ]
Frequency of defecation per week is collected by an interview questionnaire.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
  • Frequency of re-defecation after the first defecation [ Time Frame: Six months ]
    Frequency of re-defecation after the first defecation per week is collected by an interview questionnaire.
  • Defecation time [ Time Frame: Six months ]
    Defecation time (minute) is assessed by watch and collected by an interview questionnaire.
  • Sensation of non-complete defecation [ Time Frame: Six months ]
    Sensation of non-complete defecation is investigated by an interview questionnaire (0: no; 1: yes).
  • Straining forces during defecation [ Time Frame: Six months ]
    Straining forces during defecation is assessed by the rating of defecation exertion (0-1-2-3: very easy, easy, difficult, very difficult).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Defecation Postures for Functional Consumption
Official Title  ICMJE Influence of Defecation Postures on Functional Consumption in Humans
Brief Summary Whether functional consumption is influenced by defecation postures is unclear. The investigators investigated effects of defecation postures on functional consumption.
Detailed Description Constipation is a chronic problem in many patients all over the world. In some groups of patients such as the elderly, constipation is a significant health care problem. A prospective study was performed at 3 hospitals in China. The included patients were functional consumption patients with defecation sitting on a standard-sized toilet. Patients received standard functional consumption treatment according to the guideline and were randomly assigned to groups that using a squatting pan or a standard-sized toilet.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Constipation
Intervention  ICMJE Behavioral: Squatting pan
Using squatting pans to replace standard-sized toilets in one group of the included constipation patients
Study Arms  ICMJE
  • Experimental: Squatting pan
    Defecation using a squatting pan
    Intervention: Behavioral: Squatting pan
  • No Intervention: Toilet
    defecation using a standard-sized toilet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 12, 2016)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has functional constipation
  • Subject does not receive other treatments

Exclusion Criteria:

  • History of heart cerebrovascular disease
  • History of other types of constipation
  • Pregnant, trying to become pregnant or breast feeding
  • Age< 18-year and >70-year
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772692
Other Study ID Numbers  ICMJE 20160511
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Zhanwei Zhao, Air Force Military Medical University, China
Study Sponsor  ICMJE Air Force Military Medical University, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qingchuan Zhao, MD Xijing Hospital
PRS Account Air Force Military Medical University, China
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP