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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

Study Description
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Brief Summary:
Whether functional consumption is influenced by defecation postures is unclear. The investigators investigated effects of defecation postures on functional consumption.

Condition or disease Intervention/treatment Phase
Constipation Behavioral: Squatting pan Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Defecation Postures on Functional Consumption in Humans
Study Start Date : May 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Squatting pan
Defecation using a squatting pan
 Behavioral: Squatting pan
Using squatting pans to replace standard-sized toilets in one group of the included constipation patients
No Intervention: Toilet
defecation using a standard-sized toilet


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of defecation [ Time Frame: Six months ]
    Frequency of defecation per week is collected by an interview questionnaire.


Secondary Outcome Measures :
  1. 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.

  2. Defecation time [ Time Frame: Six months ]
    Defecation time (minute) is assessed by watch and collected by an interview questionnaire.

  3. Sensation of non-complete defecation [ Time Frame: Six months ]
    Sensation of non-complete defecation is investigated by an interview questionnaire (0: no; 1: yes).

  4. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02772692


Contacts
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Contact: Zhanwei Zhao, MD +86 18392186936 zzq194910@163.com

Sponsors and Collaborators
Air Force Military Medical University, China
Investigators
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Principal Investigator: Qingchuan Zhao, MD Xijing Hospital
More Information
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Publications of Results:

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Responsible Party: Zhanwei Zhao, Director, Air Force Military Medical University, China
ClinicalTrials.gov Identifier: NCT02772692    
Other Study ID Numbers: 20160511
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive