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Defecation Postures for Functional Consumption

Primary Purpose

Constipation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Squatting pan
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Squatting pan

    Toilet

    Arm Description

    Defecation using a squatting pan

    defecation using a standard-sized toilet

    Outcomes

    Primary Outcome Measures

    Frequency of defecation
    Frequency of defecation per week is collected by an interview questionnaire.

    Secondary Outcome Measures

    Frequency of re-defecation after the first defecation
    Frequency of re-defecation after the first defecation per week is collected by an interview questionnaire.
    Defecation time
    Defecation time (minute) is assessed by watch and collected by an interview questionnaire.
    Sensation of non-complete defecation
    Sensation of non-complete defecation is investigated by an interview questionnaire (0: no; 1: yes).
    Straining forces during defecation
    Straining forces during defecation is assessed by the rating of defecation exertion (0-1-2-3: very easy, easy, difficult, very difficult).

    Full Information

    First Posted
    May 11, 2016
    Last Updated
    May 12, 2016
    Sponsor
    Air Force Military Medical University, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02772692
    Brief Title
    Defecation Postures for Functional Consumption
    Official Title
    Influence of Defecation Postures on Functional Consumption in Humans
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    January 2017 (Anticipated)
    Study Completion Date
    January 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Air Force Military Medical University, China

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Constipation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Squatting pan
    Arm Type
    Experimental
    Arm Description
    Defecation using a squatting pan
    Arm Title
    Toilet
    Arm Type
    No Intervention
    Arm Description
    defecation using a standard-sized toilet
    Intervention Type
    Behavioral
    Intervention Name(s)
    Squatting pan
    Intervention Description
    Using squatting pans to replace standard-sized toilets in one group of the included constipation patients
    Primary Outcome Measure Information:
    Title
    Frequency of defecation
    Description
    Frequency of defecation per week is collected by an interview questionnaire.
    Time Frame
    Six months
    Secondary Outcome Measure Information:
    Title
    Frequency of re-defecation after the first defecation
    Description
    Frequency of re-defecation after the first defecation per week is collected by an interview questionnaire.
    Time Frame
    Six months
    Title
    Defecation time
    Description
    Defecation time (minute) is assessed by watch and collected by an interview questionnaire.
    Time Frame
    Six months
    Title
    Sensation of non-complete defecation
    Description
    Sensation of non-complete defecation is investigated by an interview questionnaire (0: no; 1: yes).
    Time Frame
    Six months
    Title
    Straining forces during defecation
    Description
    Straining forces during defecation is assessed by the rating of defecation exertion (0-1-2-3: very easy, easy, difficult, very difficult).
    Time Frame
    Six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhanwei Zhao, MD
    Phone
    +86 18392186936
    Email
    zzq194910@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Qingchuan Zhao, MD
    Organizational Affiliation
    Xijing Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    12738468
    Citation
    Roberts MC, Millikan RC, Galanko JA, Martin C, Sandler RS. Constipation, laxative use, and colon cancer in a North Carolina population. Am J Gastroenterol. 2003 Apr;98(4):857-64. doi: 10.1111/j.1572-0241.2003.07386.x.
    Results Reference
    result
    PubMed Identifier
    21666546
    Citation
    Lindberg G, Hamid SS, Malfertheiner P, Thomsen OO, Fernandez LB, Garisch J, Thomson A, Goh KL, Tandon R, Fedail S, Wong BC, Khan AG, Krabshuis JH, LeMair A; World Gastroenterology Organisation. World Gastroenterology Organisation global guideline: Constipation--a global perspective. J Clin Gastroenterol. 2011 Jul;45(6):483-7. doi: 10.1097/MCG.0b013e31820fb914. No abstract available. Erratum In: J Clin Gastroenterol. 2011 Oct;45(9):838. J Clin Gastroenterol. 2012 Jan;46(1):90. multiple author names added.
    Results Reference
    result
    PubMed Identifier
    17026568
    Citation
    Rao SS, Kavlock R, Rao S. Influence of body position and stool characteristics on defecation in humans. Am J Gastroenterol. 2006 Dec;101(12):2790-6. doi: 10.1111/j.1572-0241.2006.00827.x. Epub 2006 Oct 6.
    Results Reference
    result

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