Digital rectal examination and transabdominal ultrasound as diagnostic tools for constipation. Examination of the rectum in children with urology symptoms
Completed
- Conditions
- constipationirregularity1001797710046590
- Registration Number
- NL-OMON35605
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 85
Inclusion Criteria
- Patients scheduled for a Urology procedure in the Operation Room of Wilhelmina Children*s Hospital/ University Medical Center Utrecht or in the Emma Children's Hospital/AMC Amsyetdam
- Boys and girls
- Children age 4 -17 years
Exclusion Criteria
- Empty bladder or maximal bladder filling
- Children with known organic abnormalities/malformations or previous surgery in the anorectal/pelvic region
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The mean rectal diameter size measured by the US will be categorized in < 30 mm<br /><br>(= normal) and 30 mm or more (= abnormal). The digital rectal examination will<br /><br>give categorical data; an empty, half-filled or filled ampula. A half filled<br /><br>rectum with soft stool is considered as a fecal mass with digital examination.<br /><br>We will perform a Kappa test to know if the proportions with a characteristic<br /><br>(large and filled, normal and empty) are the same with the two tests. </p><br>
- Secondary Outcome Measures
Name Time Method <p>For all patients the rectal size category (normal or enlarged) will be compared<br /><br>to the category based on the pediatric Rome III criteria (constipation yes or<br /><br>no). A Kappa test will be done to investigate if both methods correlate.</p><br>