Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare two commonly used circumcision clamps (Gomco and Mogen) to see which results in less neonatal pain.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gomco Circumcision Clamp | Active Comparator | Gomco circumcision clamp used for neonatal circumcision. |
|
| Mogen Circumcision Clamp | Active Comparator | Mogen circumcision clamp used for neonatal circumcision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gomco Circumcision Clamp | Device | Neonatal male circumcision utilizing the Gomco Circumcision Clamp |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Salivary Cortisol Level | Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure | 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. | CRIES assessment completed prior to the procedure and post procedure. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mounira Habli, MD | TriHealth Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriHealth Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25794628 | Derived | 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. |
Not provided
Not provided
The data will be shared by manuscript.
Not provided
Not provided
Not provided
Not provided
Not provided
274 infants were enrolled into the study from 10/2012 through 6/2013.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gomco Circumcision Clamp | Gomco circumcision clamp used for neonatal circumcision. Gomco Circumcision Clamp |
| FG001 | Mogen Circumcision Clamp | Mogen circumcision clamp used for neonatal circumcision. Mogen Circumcision Clamp |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Male infants receiving circumcisions
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gomco Circumcision Clamp | Gomco circumcision clamp used for neonatal circumcision. Gomco Circumcision Clamp |
| BG001 | Mogen Circumcision Clamp | Mogen circumcision clamp used for neonatal circumcision. Mogen Circumcision Clamp |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Gestational Age (Weeks) | The data of the patients who did not receive the allocated intervention were not included in the analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neonatal Salivary Cortisol Level | Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure | Posted | Mean | Standard Deviation | mcg/dL | Approximately 2 hours before and 15 minutes after the procedure |
|
Adverse Events were collected during the infant's hospital stay and at 4-6 weeks after discharge.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gomco Circumcision Clamp | Gomco circumcision clamp used for neonatal circumcision. Gomco Circumcision Clamp |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adhesion at 2 months | Surgical and medical procedures | Physician | Systematic Assessment | Adhesion |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel G. Sinkey MD - PI | TriHealth | 513-862-6918 | pam_plummer@trihealth.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| Mogen Circumcision Clamp | Device | Neonatal male circumcision utilizing the Mogen Circumcision Clamp |
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | 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. | Posted | Median | Full Range | units on a scale | CRIES assessment completed prior to the procedure and post procedure. |
|
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | Mogen Circumcision Clamp | Mogen circumcision clamp used for neonatal circumcision. Mogen Circumcision Clamp | 0 | 117 | 2 | 117 |
|
| Pustule at head of penis - self resolved | Surgical and medical procedures | Physician | Systematic Assessment |
|
Not provided
Not provided
Not provided