Circumcision, MaleGMRTNCT01726036
Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial
A study testing Gomco Circumcision Clamp and Mogen Circumcision Clamp in people with Circumcision, Male, run by TriHealth Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 4 days, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circumcision, Male
- What is being tested?
- Gomco Circumcision Clamp and Mogen Circumcision Clamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 days
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, 45220
About this study
Official title: Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.
The purpose of this study is to compare two commonly used circumcision clamps (Gomco and Mogen) to see which results in less neonatal pain.
Read the 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
- Being tested
- Gomco Circumcision Clamp, Mogen Circumcision Clamp
- Keywords
- neonatal circumcision, neonatal surgical pain, Mogen, Gomco
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gomco Circumcision ClampDevice
Neonatal male circumcision utilizing the Gomco Circumcision Clamp
Mogen Circumcision ClampDevice
Neonatal male circumcision utilizing the Mogen Circumcision Clamp
| Study group | Role | What they receive |
|---|---|---|
| Gomco Circumcision Clamp | Active comparator | Gomco circumcision clamp used for neonatal circumcision. Receives: Device: Gomco Circumcision Clamp |
| Mogen Circumcision Clamp | Active comparator | Mogen circumcision clamp used for neonatal circumcision. Receives: Device: Mogen Circumcision Clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Salivary Cortisol Level
Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure
Measured: Approximately 2 hours before and 15 minutes after the procedure
Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool
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.
Measured: CRIES assessment completed prior to the procedure and post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circumcision, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mounira Habli, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726036
- Sponsor's protocol ID
- H-11121
- Acronym
- GMRT
- Status last verified
- Jan 2018
- First submitted
- 1 Nov 2012
- Last updated
- 5 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data will be shared by manuscript.
Publications
Sinkey RG, Eschenbacher MA, Walsh PM, Doerger RG, Lambers DS, Sibai BM, Habli MA. The GoMo study: a randomized clinical trial assessing neonatal pain with Gomco vs Mogen clamp circumcision. Am J Obstet Gynecol. 2015 May;212(5):664.e1-8. doi: 10.1016/j.ajog.2015.03.029. Epub 2015 Mar 17.
PubMed 25794628
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.
- ClinicalTrials.gov ID
- NCT01726036
- Acronym / sponsor ID
- GMRT / H-11121
- Conditions
- Circumcision, Male
- Keywords
- neonatal circumcision, neonatal surgical pain, Mogen, Gomco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Nov 2012 (estimated)
- Results
- Posted 16 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gomco Circumcision Clamp | Active comparator | Device: Gomco Circumcision ClampGomco circumcision clamp used for neonatal circumcision. |
| Mogen Circumcision Clamp | Active comparator | Device: Mogen Circumcision ClampMogen circumcision clamp used for neonatal circumcision. |
Who may qualify
- Ages
- Up to 4 days
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gomco Circumcision ClampNeonatal male circumcision utilizing the Gomco Circumcision Clamp | Device | Gomco Circumcision Clamp |
| Mogen Circumcision ClampNeonatal male circumcision utilizing the Mogen Circumcision Clamp | Device | Mogen Circumcision Clamp |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25794628Sinkey RG, Eschenbacher MA, Walsh PM, Doerger RG, Lambers DS, Sibai BM, Habli MA. The GoMo study: a randomized clinical trial assessing neonatal pain with Gomco vs Mogen clamp circumcision. Am J Obstet Gynecol. 2015 May;212(5):664.e1-8. doi: 10.1016/j.ajog.2015.03.029. Epub 2015 Mar 17.
- Individual participant dataSharing planned: Yes. The data will be shared by manuscript.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mounira Habli, MD principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gomco Circumcision Clamp and Mogen Circumcision Clamp in people with Circumcision, Male, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Salivary Cortisol Level (time frame: Approximately 2 hours before and 15 minutes after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01726036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.