ConstipationNCT02772692
Defecation Postures for Functional Consumption
A study testing Squatting pan in people with Constipation, run by Air Force Military Medical University, China.
Trial summary
Whether functional consumption is influenced by defecation postures is unclear. The investigators investigated effects of defecation postures on functional consumption. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Constipation
- What is being tested?
- Squatting pan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has functional constipation
- Subject does not receive other treatments
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Constipation
- Being tested
- Squatting pan
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Squatting panBehavioural
Using squatting pans to replace standard-sized toilets in one group of the included constipation patients
| Study group | Role | What they receive |
|---|---|---|
| Squatting pan | Experimental | Defecation using a squatting pan Receives: Behavioral: Squatting pan |
| Toilet | No intervention | defecation using a standard-sized toilet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of defecation
Frequency of defecation per week is collected by an interview questionnaire.
Measured: Six months
Secondary outcomes (4)
Frequency of re-defecation after the first defecation
Frequency of re-defecation after the first defecation per week is collected by an interview questionnaire.
Measured: Six months
Defecation time
Defecation time (minute) is assessed by watch and collected by an interview questionnaire.
Measured: Six months
Sensation of non-complete defecation
Sensation of non-complete defecation is investigated by an interview questionnaire (0: no; 1: yes).
Measured: Six months
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).
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhanwei Zhao, Air Force Military Medical University, China
- Investigators
- Qingchuan Zhao, MD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772692
- Sponsor's protocol ID
- 20160511
- Status last verified
- May 2016
- First submitted
- 11 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
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.
PubMed 12738468Lindberg 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.
PubMed 21666546Rao 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.
PubMed 17026568
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Defecation Postures on Functional Consumption in Humans
- ClinicalTrials.gov ID
- NCT02772692
- Acronym / sponsor ID
- 20160511
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Squatting pan | Experimental | Behavioral: Squatting panDefecation using a squatting pan |
| Toilet | No intervention | –defecation using a standard-sized toilet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has functional constipation
- Subject does not receive other treatments
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Squatting panUsing squatting pans to replace standard-sized toilets in one group of the included constipation patients | Behavioural | Squatting pan |
Primary outcome
Frequency of defecation
Time frame: Six months
Frequency of defecation per week is collected by an interview questionnaire.
4 secondary outcomes
Frequency of re-defecation after the first defecation
Time frame: Six months
Defecation time
Time frame: Six months
Sensation of non-complete defecation
Time frame: Six months
Straining forces during defecation
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Results publication: PubMed 12738468Roberts 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 publication: PubMed 21666546Lindberg 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.
- Results publication: PubMed 17026568Rao 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qingchuan Zhao, MD principal investigator
Xijing Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Squatting pan in people with Constipation, run by Air Force Military Medical University, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhanwei Zhao, MD (+86 18392186936, zzq194910@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of defecation (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02772692, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.