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

Status

Unknown

Conditions

Intervention / Treatment

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.

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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