Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial (GMRT)
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| ClinicalTrials.gov Identifier: NCT01726036 |
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Recruitment Status :
Completed
First Posted : November 14, 2012
Last Update Posted : November 13, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neonatal Circumcision | 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 |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Single (Outcomes Assessor) |
| Official Title: | Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study. |
| Study Start Date : | October 2012 |
| Actual Primary Completion Date : | March 2014 |
| Actual Study Completion Date : | September 2014 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Gomco Circumcision Clamp
Gomco circumcision clamp used for neonatal circumcision.
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Device: Gomco Circumcision Clamp |
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Active Comparator: Mogen Circumcision Clamp
Mogen circumcision clamp used for neonatal circumcision.
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Device: Mogen Circumcision Clamp |
- Neonatal pain [ Time Frame: Approximately 2 hours before and 15 minutes after the procedure ]Neonatal pain will be assessed by change in salivary cortisol level pre and post procedure
- Bleeding [ Time Frame: Approximately 10 minutes after the procedure ]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 ]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 ]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 ]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 ]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. ]Standardized score including vital signs and facial expression
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| Ages Eligible for Study: | up to 4 Days (Child) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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.
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 | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | TriHealth Inc. |
| ClinicalTrials.gov Identifier: | NCT01726036 History of Changes |
| Other Study ID Numbers: |
H-11121 |
| First Posted: | November 14, 2012 Key Record Dates |
| Last Update Posted: | November 13, 2014 |
| Last Verified: | March 2014 |
Keywords provided by TriHealth Inc.:
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neonatal circumcision neonatal surgical pain Mogen Gomco |