3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02812836|
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : November 14, 2018
Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that measures pressures along the anal canal in a very detailed manner. It provides complete data about pressure profile of anorectum and may indicate impaired defecation dynamics. Balloon expulsion test (BET) is a cheap, easy way to diagnose constipation as the result of outlet obstruction.
Our aim is to compare this two methods of diagnosis of dyssynergic defecation and to find the correlation between this diagnostic equipment.
|Condition or disease||Intervention/treatment||Phase|
|Children Constipation||Device: Manometry||Not Applicable|
Patients with the diagnosis of constipation will be enrolled in the study. Each patient will be investigated by anorectal manometry and after the procedure BET will be performed at the same day.
During anorectal manometry conventional manometric parameters will be recorded, such as resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded.
After the manometry standard BET will be performed. The balloon will be inserted into the rectum and patient will be asked to expel it in private during 1 min.
Data from manometry will be correlated with the success rate of BET.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation in Children|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||March 1, 2019|
All patients will be investigated by anorectal manometry and after the procedure with balloon expulsion test as previously described.
Each patient will be investigated first by anorectal manometry, standard protocol of conventional parameters will be recorded such as: resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded. After that balloon with 50 ml of water will be inserted into the rectum and patient will be asked to expel the device within 1 min in privacy.
Other Name: Balloon
- Correlation between percent of dyssynergic defecation diagnosed by the manometry and BET. [ Time Frame: 30 min ]Percent of patients with the diagnosis of dyssynergic defecation made by BET and according to manometric equipment.
- Bear down manoeuver pressure differential [ Time Frame: 1 min ]Pressures of rectum and anal canal during bear down manoeuver will be recorded 3 times. Patients will be classified as dyssynergic defecation type. Correlation between the type and the result of BET will be evaluated.
- puborectalis muscle pressure [ Time Frame: 1 min ]3D picture of anal canal will be recorded and pressure of puborectalis muscle will be recorded during rest and squeeze. The level of pressure will be correlated with the result of BET
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812836
|Contact: Marcin Banasiuk, PhDemail@example.com|
|Department of Pediatric Gastroenterology and Nutrition||Recruiting|
|Warsaw, Poland, 02-091|
|Contact: Marcin Banasiuk, PhD +48223179463 firstname.lastname@example.org|
|Principal Investigator: Marcin Banasiuk, PhD|
|Principal Investigator:||Marcin Banasiuk, PhD||Medical University of Warsaw|