Defecation Postures for Functional Consumption

Constipation Clinical Trial

Official title:

Influence of Defecation Postures on Functional Consumption in Humans

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02772692
• Other study ID #: 20160511
• Status: Not yet recruiting
• Phase: N/A
• First received: May 11, 2016
• Last updated: May 12, 2016
• Start date: May 2016
• Est. completion date: January 2017

Study information

• Verified date: May 2016
• Source: Fourth Military Medical University
• Contact: Zhanwei Zhao, MD
• Phone: +86 18392186936
• Email: zzq194910[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Whether functional consumption is influenced by defecation postures is unclear. The investigators investigated effects of defecation postures on functional consumption.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Behavioral:
• Squatting pan
Using squatting pans to replace standard-sized toilets in one group of the included constipation patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

References & Publications (3)

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: Constip — View 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. Epub 2006 Oct 6. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of defecation	Frequency of defecation per week is collected by an interview questionnaire.	Six months	No
Secondary	Frequency of re-defecation after the first defecation	Frequency of re-defecation after the first defecation per week is collected by an interview questionnaire.	Six months	No
Secondary	Defecation time	Defecation time (minute) is assessed by watch and collected by an interview questionnaire.	Six months	No
Secondary	Sensation of non-complete defecation	Sensation of non-complete defecation is investigated by an interview questionnaire (0: no; 1: yes).	Six months	No
Secondary	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).	Six months	No