Determining normal anorectal physiology values in healthy females.

Not Applicable

Recruiting

• Conditions: Anorectal physiology in healthy subjects; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12616000334404
• Lead Sponsor: orthern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Inclusion criteria include:
1-Age between 20 and 75
2-Females
3-English speakers
4-Willingness to answer screening questionnaire
5-Willingness to give written informed consent
6-Willingness to comply with the study.

Exclusion Criteria

All volunteers will be requested to answer a screening questionnaire. This will not be reimbursed.

Exclusion criteria include:
1.Women lactating or pregnant
2.Definable gastrointestinal disorder based on the ROME questionnaire componenet of the screening questionnaire. .
3.Presence of overt organic anorectal disorder
4.Medications that alter motility of the GI tract such as loperamide.
5.History of anorectal or distal colon surgery.
6.History of complicated delivery
7.Previous anorectal physiological testing.
8.Patients with a history of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study. Psychological illness or condition will be assessed by: (1) HAD, (2) screening questionnaire questions about medical conditions, current medications, and (3) brief physician interview and discussion of PISCF before patients consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For the primary outcome of determining the normal range of values of anorectal sensorimotor physiological testing in healthy volunteers, the outcome measures are the results of the test performed. These include mean (+-SD) of anal resting pressure, anal pressure on squeeze, anal squeeze duration, rectal pressure on strain, anal relaxation on strain, sensory thresholds and balloon expulsion time. [end of study procedure]

Secondary Outcome Measures

Name	Time	Method
For the secondary outcome of determining the best method of measuring rectal sensitivity, the outcome measure will be the correlation between elastic balloon measurements and the barostat measurements of rectal sensitivity. [end of study procedure];For the optimum method of diagnosing dyssenergic defecation using balloon expulsion time, the outcome measure will be time taken to evacuate the different balloons using the three methods described above. [end of study procedure]