- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02772692
Defecation Postures for Functional Consumption
May 12, 2016 updated by: Zhanwei Zhao, Air Force Military Medical University, China
Influence of Defecation Postures on Functional Consumption in Humans
Whether functional consumption is influenced by defecation postures is unclear.
The investigators investigated effects of defecation postures on functional consumption.
Study Overview
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
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Squatting pan
Defecation using a 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of defecation
Time Frame: Six months
|
Frequency of defecation per week is collected by an interview questionnaire.
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Six months
|
Defecation time
Time Frame: Six months
|
Defecation time (minute) is assessed by watch and collected by an interview questionnaire.
|
Six months
|
Sensation of non-complete defecation
Time Frame: Six months
|
Sensation of non-complete defecation is investigated by an interview questionnaire (0: no; 1: yes).
|
Six months
|
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).
|
Six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Qingchuan Zhao, MD, Xijing Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Anticipated)
January 1, 2017
Study Completion (Anticipated)
January 1, 2017
Study Registration Dates
First Submitted
May 11, 2016
First Submitted That Met QC Criteria
May 12, 2016
First Posted (Estimate)
May 13, 2016
Study Record Updates
Last Update Posted (Estimate)
May 13, 2016
Last Update Submitted That Met QC Criteria
May 12, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20160511
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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