NCT01726036

Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial

Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: TriHealth Inc. · Academic / Other
• Sex: Male
• Age: 4 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare two commonly used circumcision clamps (Gomco and Mogen) to see which results in less neonatal pain.

Detailed description

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.

Conditions

• Circumcision, Male

Interventions

Type	Name	Description
DEVICE	Gomco Circumcision Clamp	Neonatal male circumcision utilizing the Gomco Circumcision Clamp
DEVICE	Mogen Circumcision Clamp	Neonatal male circumcision utilizing the Mogen Circumcision Clamp

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-03-01
• Completion: 2014-09-01
• First posted: 2012-11-14
• Last updated: 2019-06-05
• Results posted: 2019-05-16

Locations

1 site across 1 country: United States