Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial (GMRT)
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|ClinicalTrials.gov Identifier: NCT01726036|
Recruitment Status : Completed
First Posted : November 14, 2012
Results First Posted : May 16, 2019
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Circumcision, Male||Device: Gomco Circumcision Clamp Device: Mogen Circumcision Clamp||Not Applicable|
Objective: To compare pain levels assessed by salivary cortisol and standardized neonatal pain scale among the two most common infant circumcision techniques in uncomplicated pregnancies after a thorough resident-wide education curriculum under attending physician supervision.
The secondary objectives are to assess the operative time, complication rates such as infection and bleeding and short term outcomes including need for re-circumcision among treatment groups.
Hypothesis: The Mogen technique of circumcision is less painful, faster, and associated with less bleeding for newborns when compared to the Gomco technique after a resident circumcision standard teaching curriculum.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||274 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.|
|Actual Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||September 2014|
Active Comparator: Gomco Circumcision Clamp
Gomco circumcision clamp used for neonatal circumcision.
Device: Gomco Circumcision Clamp
Neonatal male circumcision utilizing the Gomco Circumcision Clamp
Active Comparator: Mogen Circumcision Clamp
Mogen circumcision clamp used for neonatal circumcision.
Device: Mogen Circumcision Clamp
Neonatal male circumcision utilizing the Mogen Circumcision Clamp
- Neonatal Salivary Cortisol Level [ Time Frame: Approximately 2 hours before and 15 minutes after the procedure ]Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure
- Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool [ Time Frame: CRIES assessment completed prior to the procedure and post procedure. ]The CRIES score assigns points for crying characteristics, oxygen requirements, change in vital signs, facial expressions, and the infant's sleep state. The minimum and maximum scores of CRIES is 0 to 10, respectively with the lower score associated with lower pain and the higher score associated with high amount of pain.
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): NCT01726036
|United States, Ohio|
|TriHealth Good Samaritan Hospital|
|Cincinnati, Ohio, United States, 45220|
|Principal Investigator:||Mounira Habli, MD||TriHealth Inc.|