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

This study is currently recruiting participants. ClinicalTrials.gov Identifier:

Verified October 2013 by TriHealth Inc.

NCT01726036
First received: November 1, 2012
Sponsor:
Last updated: October 7, 2013
TriHealth Inc.
Last verified: October 2013
Information provided by (Responsible Party): History of Changes
TriHealth Inc.

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Purpose

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

Condition Intervention
 Neonatal Circumcision Device: Gomco Circumcision Clamp
Device: Mogen Circumcision Clamp

Study Type: Interventional

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.

Resource links provided by NLM:

MedlinePlus related topics: Circumcision

U.S. FDA Resources

Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Other Outcome Measures:

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

Estimated Enrollment: 274

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)

Arms Assigned Interventions

Active Comparator: Gomco Circumcision Clamp Device: Gomco Circumcision Clamp

Gomco circumcision clamp used for neonatal circumcision.

Active Comparator: Mogen Circumcision Clamp Device: Mogen Circumcision Clamp

Mogen circumcision clamp used for neonatal circumcision.

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.

Eligibility
Ages Eligible for Study: up to 4 Days
Genders Eligible for Study: Male
Accepts Healthy Volunteers: Yes

Criteria
Inclusion Criteria:
term infants delivered by cesarean section or vaginal delivery at Good Samaritan Hospital during the time period of the study
Infants with no blood drawn two hours prior to the circumcision
Singletons
Exclusion Criteria:
Infants with congenital anomalies and/or known chromosomal syndromes
Preterm infants defined as less than 37 / 0 weeks gestation.
Delivery secondary to non-reassuring fetal heart tracing, defined by the delivering physician
Infants of diabetic mothers.
Infants of preeclamptic mothers on magnesium sulfate within 48 hours of delivery.
Infants delivered by vacuum-assisted or forceps-assisted vaginal delivery.
Infants of mothers who took steroids for fetal lung maturity within 7 days of delivery. (This may apply to term infants if the mother had no prenatal
care and her gestational age was not known on arrival).
Infants with a 5 minutes apgar score of less than 7
Infants born to mothers with a history of drug abuse during pregnancy, currently on methadone, or with Hepatitis C or HIV.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726036

Contacts

Contact: Mounira Habli, MD mounira_habli@trihealth.com

Contact: Rachel Sinkey, MD rachel_sinkey@trihealth.com

Locations

United States, Ohio

United States, Ohio

TriHealth Good Samaritan Hospital Recruiting

Cincinnati, Ohio, United States, 45220
Contact: Michaela Eschenbacher, MPH michaela_eschenbacher@trihealth.com
Principal Investigator: Mounira Habli, MD

Sponsors and Collaborators

TriHealth Inc.

More Information

No publications provided

Responsible Party: TriHealth Inc.

ClinicalTrials.gov Identifier: NCT01726036 History of Changes
Other Study ID Numbers: H-11121
Study First Received: November 1, 2012
Last Updated: October 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by TriHealth Inc.:

neonatal circumcision
neonatal surgical pain
Mogen
Gomco

ClinicalTrials.gov processed this record on October 07, 2013

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