Abstract
Circumcisions using local anesthesia are among the most common procedures performed in the neonatal period and are typically performed using one of three techniques—Mogen clamp, Gomco clamp, or Plastibell device. Comparative data regarding outcomes, specifically rates of complications such as bleeding for which emergency room (ER) evaluation and intervention are indicated as well as operative revision of circumcision, remain unknown. This retrospective review aimed to better define rates of complications for each of the three procedure types. There were statistically significant differences between the three circumcision types as they relate to the subjective report of pain, but there were no statistically significant differences between the three circumcision modalities regarding rates of complications or return to the ER. Neonatal local circumcisions by these devices are all well tolerated with no demonstrable differences in outcomes. Careful patient selection and surgeon preference should continue to drive the approach utilized.
Keywords
Neonatal circumcisions using local anesthesia are among the most common procedures performed in the neonatal period. 1 Circumcision entails the removal of the foreskin covering the glans penis. It has been shown to prevent urinary tract infections, transmission of sexually transmitted infections, and penile cancer while not adversely affecting penile sexual function/sensitivity or sexual satisfaction. 1 Most typically, this is completed by one of three methods—Mogen clamp, Gomco clamp, or Plastibell device. The Mogen and Gomco clamps protect the glans while causing crush injury to the underlying prepuce which is ultimately transected and removed. 2 The Plastibell device, on the other hand, induces tissue necrosis which is sloughed off several days after the procedure along with the plastic shield. 2
The incidence of complications by procedure type remains unknown and comparative data is lacking. As such, this study aims to better define rates of complications for each of the three procedure types by evaluating the incidence of complications following circumcisions performed under local anesthesia by pediatric surgeons in the neonatal period.
This study is a retrospective review determining and comparing complication rates (return to the emergency room and/or surgical procedure in the operating room) among neonatal pediatric patients who underwent elective circumcision under local anesthesia by a pediatric general surgeon at Joe DiMaggio Children’s Hospital from October 2019 to August 2021.
Data collected included patient demographics (gestational age at delivery (weeks), age at the time of circumcision (days), weight at the time of circumcision, personal history of bleeding disorder, family history of bleeding disorder, use of antiplatelet/anticoagulant therapy at time of circumcision, and type of medical problems), specifics regarding the procedure (date of procedure, type of circumcision performed, type of anesthetic administered (penile block, EMLA), hemostatic agent used (silver nitrate, epinephrine solution), and pain score during the procedure), and post-procedural factors (date of initial follow-up, date of most recent follow-up, complications noted, return to the operating room (OR) for circumcision-related complications, return to the emergency room (ER) with circumcision-related complications, pain prior to discharge, pain reported at follow-up by the family, satisfactory score per provider and per family, time from procedure to follow-up, time from procedure to ER, and time from procedure to OR).
Descriptive statistics were calculated for all demographic, perioperative, and postoperative or outcome variables. Pearson’s chi-square test or, where appropriate, Fisher’s exact test was used to compute frequencies and proportions for categorical variables. For continuous variables, Mood’s median test was used to determine if medians were the same across the 3 circumcision types. Results were statistically significant at P < 0.05. All analyses were conducted using Stata/SE 15.1.
Demographics, Clinical Characteristics, Reported Pain, Appearance Satisfaction by Circumcision Type, Complications, and Postsurgical Outcomes by Circumcision Type.
NE = Not Estimable. IQR = Interquartile Range.
Proportions represent column percentages. Proportions may not add to 100% due to missing data and/or rounding errors.
Bold face font indicates statistical significance at P < 0.05.
aOnly among the cohort of neonatal patients who underwent Plastibell elective circumcision.
Reported pain and appearance satisfaction measures were assessed on a scale of 0-100.
Postoperative outcomes were evaluated by returns to the ER, returns to the OR, and rate of postoperative complications, that is, bleeding and adhesions. Comparing the three circumcision types, there were no statistically significant differences in any of these variables mentioned (Table 1). There were statistically significant differences between the three circumcision types as they related to the subjective report of pain. The Gomco cohort reported a substantially lower median rating of pain during the procedure compared to all other circumcision types (Mogen: 66 reported pain; Gomco: 15.5 reported pain; Plastibell: 58 reported pain) (P < 0.001). Similarly, the Gomco cohort also had the lowest median rating of pain prior to discharge (P < 0.001).
Further, statistically significant differences were also observed among recipients of EMLA, silver nitrate, or topical epinephrine solution. A majority of patients who underwent Mogen circumcision did not receive EMLA nor silver nitrate while most patients who underwent Gomco or Plastibell circumcision received EMLA or silver nitrate (P < 0.001). While all patients who underwent Gomco or Plastibell circumcision did not receive topical epinephrine solution, approximately 28% of patients who underwent Mogen circumcision received topical epinephrine solution for hemostasis (P < 0.001).
Lastly, the proportion of patients who completed an initial follow-up visit following circumcision differed significantly with the Mogen cohort (78.3%) having the highest proportion of patients with an initial follow-up followed by the Plastibell cohort (67.1%) (P = 0.019). Furthermore, the median time to initial follow-up visit between the three groups differed significantly with the Plastibell cohort having the longest time between procedure and the initial follow-up visit (15.0 days) compared to all other circumcision types (Mogen: 8.0 days vs Gomco: 14.0 days) (P < 0.001).
Some randomized studies have suggested that the Mogen clamp produces less pain than the Gomco clamp and Plastibell device.3,4 Our study demonstrated that pain ratings during the procedure and prior to discharge were significantly lower for the Gomco clamp cohort compared to the Mogen clamp and Plastibell device groups. Statistically significant differences were also observed between groups with respect to the use of EMLA and topical epinephrine solution. Most patients who underwent Mogen circumcision did not receive EMLA while most patients who underwent Gomco or Plastibell circumcision did. The variability in analgesia administration underscores the need for standardized pain management protocol which can further reduce procedural discomfort. Future studies evaluating pain using a universally accepted standardized approach would be beneficial.
Beyond pain management, the proportion of patients compliant with recommended follow-up visits and the timing of these visits varied significantly among the three groups. Patients in the Mogen cohort had the highest rates of follow-up attendance, while the Plastibell group had the longest time to initial follow-up. Delayed follow-up in the Plastibell cohort might be attributed to the device’s mechanism of action, as the plastic shield typically falls off several days post-procedure, potentially leading families to delay follow-up visits until after this process. Despite these differences, there were no statistically significant differences between the three circumcision modalities regarding the rate of complications such as post-procedural bleeding or rates of return to the ER. Nonetheless, improving compliance with follow-up and standardizing timelines for post-procedural evaluations are critical for early identification and management of complications.
This study is limited by its retrospective design which subjects it to selection bias and accuracy of documentation. Additionally, the absence of validated pain scales for this purpose and potential variability in documentation of complications may have influenced the findings. Pain assessment in neonates is inherently challenging, and in this study specifically, pain was evaluated based on crying time, heart rate, and respiratory rate, all of which are not specific indicators of pain. Therefore, future studies could benefit from utilizing validated neonatal pain scales, such as the Neonatal Infant Pain Scale (NIPS) or Premature Infant Pain Profile (PIPP), which incorporate physiological and behavioral parameters.
Footnotes
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.