Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial (GMRT)
The purpose of this study is to compare two commonly used circumcision clamps (Gomco and Mogen) to see which results in less neonatal pain.
Device: Gomco Circumcision Clamp
Device: Mogen Circumcision Clamp
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
|Official Title:||Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.|
- Neonatal pain [ Time Frame: Approximately 2 hours before and 15 minutes after the procedure ] [ Designated as safety issue: Yes ]Neonatal pain will be assessed by change in salivary cortisol level pre and post procedure
- Bleeding [ Time Frame: Approximately 10 minutes after the procedure ] [ Designated as safety issue: Yes ]Bleeding is measured by weight of blood soaked gauzes after the procedure
- Procedural Time [ Time Frame: Participants will be followed for the duration of procedure, average 4 minutes ] [ Designated as safety issue: Yes ]Time needed to complete the circumcision:start time from local anesthesia to end of circumcision.
- Parental satisfaction [ Time Frame: Approximately 6 weeks after the procedure ] [ Designated as safety issue: No ]Approximately 6 weeks after the procedure parental satisfaction will be assessed by a phone survey.
- Need for circumcision revision [ Time Frame: Approximately 6 weeks after the circumcision ] [ Designated as safety issue: Yes ]Approximately 6 weeks after the procedure the pediatrician's office will be contacted to see if a circumcision revision was needed.
- Postoperative infection [ Time Frame: Approximately 6 weeks after circumcision ] [ Designated as safety issue: Yes ]Approximately 6 weeks after the circumcision the pediatrician's office will be contacted regarding surgical site infection.
- Neonatal pain score [ Time Frame: Assesed from time of recruitment to end of procedure, approximately 1 day. ] [ Designated as safety issue: Yes ]Standardized score including vital signs and facial expression
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Gomco Circumcision Clamp
Gomco circumcision clamp used for neonatal circumcision.
|Device: Gomco Circumcision Clamp|
Active Comparator: Mogen Circumcision Clamp
Mogen circumcision clamp used for neonatal circumcision.
|Device: Mogen Circumcision Clamp|
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.
|Contact: Mounira Habli, MDemail@example.com|
|Contact: Rachel Sinkey, MDfirstname.lastname@example.org|
|United States, Ohio|
|TriHealth Good Samaritan Hospital||Recruiting|
|Cincinnati, Ohio, United States, 45220|
|Contact: Michaela Eschenbacher, MPH email@example.com|
|Principal Investigator: Mounira Habli, MD|