Plastibell Research Articles

Sutureless and Scalpel-Free Circumcision—More Rapid, Less Expensive and Better?

We previously reported our success with sutureless circumcision using 2-octyl cyanoacrylate in 267 patients. We have since modified our technique by making incisions with electrocautery. We report our results with this novel technique. We also performed a cost analysis. We compiled data on all patients 6 months to 12 years old who underwent primary circumcision and circumcision revision in a 39-month period, as done by 3 surgeons. Study exclusion criteria were complexity beyond phimosis and Gomco clamp use. The technique included 1) a circumferential inner incision using electrocautery on cutting current, 2) a circumferential outer incision using electrocautery, 3) foreskin removal, 4) hemostasis with electrocautery, 5) skin edge approximation with 2-octyl cyanoacrylate or 6-zero suture and 6) antibiotic ointment application. We also determined the cost of all procedures based on anesthesia and operating room facility fees, and material costs. Between July 1, 2006 and October 1, 2009 we performed 493 primary circumcisions and 248 revisions using 2-octyl cyanoacrylate, and 152 primary circumcisions and 115 revisions using 6-zero sutures. Mean operative time for primary circumcision and revision using 2-octyl cyanoacrylate was 8 minutes (range 6 to 18), and for sutured primary circumcision and revision it was 27 minutes (range 18 to 48). At a mean 18-month followup (range 1 to 39) 3 patients treated with 2-octyl cyanoacrylate and 2 treated with sutures were rehospitalized for bleeding. When done with electrocautery, the cost of the 2-octyl cyanoacrylate technique was $743.55 less than the sutured technique as long as the 2-octyl cyanoacrylate procedures required less than 15 minutes and the sutured procedures required more than 15 minutes. Combined electrocautery and 2-octyl cyanoacrylate for circumcision is a safe, efficient, financially beneficial, cosmetically appealing alternative to traditional circumcision done with scalpel and sutures.

No-Needle Local Anesthesia for Adult Male Circumcision

We used a local anesthetic jet injection technique for adult male circumcision. This method eliminates needle use and may decrease the fear of local anesthetic injection used for male circumcision. We recruited 60 men seeking voluntary adult male circumcision into the study from June to September 2009. We used a MadaJet Medical Injector to deliver a high pressure spray of 0.1 ml 2% plain lidocaine solution directly through the penile skin circumferentially around the proximal third of the penis. All men underwent circumcision using the Shang Ring and were evaluated for anesthetic safety, efficacy and acceptability. Pain was measured on a visual analog scale. The average volume of 2% lidocaine anesthetic solution delivered by jet injection was 0.1 ml with a mean total of 0.9 ml per circumcision procedure. More than 85% of men did not require supplemental anesthesia. Anesthetic onset required approximately 45 seconds from the time that injections were completed. Mean pain scores for immediate postoperative, 24-hour postoperative, ring removal and post-ring removal events were 0.1, 6.8, 2.2 and 0.9, respectively. In 4 patients (6.67%) mild urethral bleeding resolved with pressure, resulting in technique modification. No-needle jet injection is safe and effective for adult MC. The technique efficiently delivers local anesthesia with rapid onset in men undergoing circumcision. This needle-free approach may enhance the popularity of adult male circumcision.

Circumcision complications associated with the Plastibell device.

To the Editor: Sociocultural or non-medical circumcision continues to be a common practice in the Western Cape. The Plastibell (Hollister Inc., Libertyville, Ill., USA) is the most frequently used device in the local community setting. Hollister South Africa (Pty) Ltd sold 6 050 Plastibell devices in South Africa in 2003. Popularity of the device can be ascribed to its claimed ‘ease of use’. It involves a technique that can be performed under local anaesthetic.

Sutureless Circumcision Using 2-Octyl Cyanoacrylate (Dermabond): Appraisal After 18-Month Experience

2-Octyl cyanoacrylate (2-OCA; Dermabond) is a synthetic tissue adhesive that has proven utility in the closure of minor surgical incisions. Recently, we began using this adhesive for skin closure after circumcision and herein report our experience. A total of 267 patients (mean age 4 years) underwent circumcision (n = 208) or circumcision revision (n = 59) using 2-OCA for skin closure. The circumcision was performed using a sleeve technique in 219 patients and a Gomco clamp in 48. After meticulous hemostasis, the incision was cleansed, and the skin edges were aligned. Two thin layers of 2-OCA were applied to the incision and allowed to dry. Antibiotic ointment was then applied to the glans and penis. The technique was not used if poor skin edge apposition or bleeding was noted after circumcision. The skin closure time using 2-OCA averaged 3 minutes for the first 150 patients and less than 90 seconds for the last 120 patients, reflecting a learning curve associated with application. At a mean follow-up of 13 months (range 2 to 18), three postoperative complications had occurred. The cosmetic outcomes have been subjectively better than those with standard closure using interrupted 5-0 or 6-0 sutures, with no risk of suture tracks or sinuses. Parental satisfaction has been consistently great. Sutureless circumcision closure using 2-OCA is a safe, fast, and cosmetically appealing alternative to standard interrupted suture reapproximation. These advantages have made it our technique of choice. A direct economic and outcome comparison to sutured repairs is ongoing.

Is Neonatal Circumcision Judicious?

Circumcision is the most frequently performed procedure in male children. The aim of the study was to compare the outcome of circumcision performed in the early neonatal period and circumcision performed at 5 months of age. Setting of the study was the King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia. The study was performed as a prospective cohort study. A total of 350 infants were enrolled. 250 neonates were circumcised at the age of 1 to 4 days (early group) and 100 infants underwent circumcision at the age of 5 months (late group). A bone cutter was used for 50 neonates, a Gomco clamp in another 50 neonates, and a Plastibell in the remaining 250 cases (150 in the early group and 100 in the late group). Complications including meatal deformities, meatal stenosis, adhesions and infection were more frequent and more significant in the neonatal circumcision group. From our study, circumcision at 5 months results in significantly fewer serious complications than circumcision in the neonatal period, irrespective of the method used. Therefore, neonatal circumcision should not be recommended.

Aretrospective clinical analysis between plastibell circumcision and circumcision in children

目的 探讨小儿包皮过长、包茎的手术较佳方式.方法 对1997年至2005年826例(随机分为环套术631例、环切术195例)小儿包茎、包皮过长进行回顾性分析,采用χ2检验.结果 手术时间分别为(4±1)min和(20±5)min(P＜0,01);总并发症发生率分别为5.23%(33/631)和18.97%(37/195)(P＜0.01);术后护理工作量:环套术组明显简单于环切术组.结论 小儿包皮过长、包茎以包皮环套术为优。

A New Convenient Device of Circumcision

A New Convenient Device of Circumcision Jae Hung Jung, Sang Bong Lee, Jae Mann Song From the Department of Urology, Yonsei University Wonju College of Medicine and Lee Sang Bong Urology and Dermatology Clinic, Wonju, Korea Purpose: Circumcision is widely practiced in Korea. Circumcision has been popularly performed with mechanical devices such as the Gomco clamp, the Plastibell device and other modified devices. We investigate the effect of using a new device (the circumcision clamp). Materials and Methods: We conducted a retrospective study between December 2003 and February 2004 on 75 patients who wanted circumcision. 25 patients were operated on by performing conventional circumcision, and 50 patients were operated on by using the circumcision clamp. Results: The mean operation time for the new device group was shorter than that for the conventional circumcision group (p<0.05). No significant difference of complications was noted between the conventional circumcision group and the circumcision clamp group. Conclusions: The new method with using the circumcision clamp has a benefit as it is designed to expose the glans and it saves operating time. (Korean J Urol 2006;47:1099-1102) ꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏ Key Word: Circumcision 대한비뇨기과학회지 제 47권 제 10호 2006

What’s New in the Management of Pain in Children

What’s New in the Management of Pain in Children

Revision of circumcision in children: Report of 56 cases

Background/Purpose: Circumcision is the most commonly performed surgical procedure in the United States today. Despite the large number of specialists who perform this procedure, only occasionally are the results unsatisfactory. The purpose of this study is to review the indications for circumcision revision, attempt to identify the specialists who are performing unsatisfactory circumcisions, describe the authors' surgical technique for circumcision revision, and review current coding and billing issues related to this procedure. Methods: The authors reviewed the charts of 56 consecutive children who underwent circumcision revision over a 4-year period (1995 to 1999). They also reviewed their current coding and billing practices for this procedure. Results: Children undergoing revision of circumcision ranged in age from 6 weeks to 11 years with a mean of 26.7 months. Redundant foreskin was the most common indication for circumcision revision. In 38 patients (68%) the authors were able to identify the specialist who performed the procedure. Pediatricians were most commonly identified (n = 26), followed by residents in training (n = 10) family physician (1), and nurse midwife (1). The authors were unable to identify the type of neonatal circumcision originally performed. Their surgical procedure was the conventional sleeve technique without variation in 55 cases. A gomco clamp was utilized in one patient under local anesthesia and resulted in significant difficulty in the performance of the revision. All patients had a satisfactory cosmetic outcome. There was one complication in a child who required a return to the operating room for postoperative bleeding and hematoma. In review of the authors coding practices they found that there was an appropriate diagnosis code available for redundant foreskin but a specific procedure code was lacking before 2002. The authors also found that midwives perform circumcisions throughout the United States. Conclusions: Considering the number of neonatal circumcisions performed in the United States, revision of circumcision uncommonly is required. The most common indication for circumcision revision is redundant foreskin. Although pediatricians were most commonly implicated in this study as the source of unsatisfactory circumcisions, that finding probably is more a reflection of local practices and referral patterns. Our recommended surgical procedure, the conventional sleeve technique, is familiar to pediatric surgeons, produces a satisfactory cosmetic result, and is easy to teach to residents and fellows. The authors do not recommend the use of a gomco clamp for circumcision revision. The authors do not feel that a circumcision revision should be delayed expecting that the child will grow into the redundant foreskin. Appropriate diagnosis codes have been available, but a new and more specific procedure code has just been introduced in 2002. J Pediatr Surg 37:1343-1346. Copyright 2002, Elsevier Science (USA). All rights reserved.

The benefits of histoacryl tissue glue over sutures for wound approximation after circumcision with Gomco clamp

We conclude that HTG is a safe and effective method of wound approximation after circumcision.

Gomco circumcision: When is it safe?

Background/Purpose: The Gomco clamp is used most commonly for neonatal circumcisions in the United States with reported rates of complication as low as 0.2%. Often, however, circumcision is delayed beyond the neonatal period because of illness, parental concerns, or physician bias with patients presenting for elective circumcision in the first few years of life. In neonates and infants, the “bloodless” Gomco circumcision is cost effective, can be performed with minimal anesthesia and gives good cosmetic results. However, the optimal age at which to perform this procedure remains controversial. We reviewed the experience of one pediatric urologist with Gomco circumcision in neonates and infants to determine the optimal age at which this procedure should be performed. Methods: One hundred thirty patients underwent Gomco circumcision by 1 pediatric urologist between 1996 and 1998. Ninety-eight patients underwent Gomco circumcision as neonates or during early infancy at a mean age of 17 days (range, 4 to 30 days). Thirty-two patients underwent circumcision after early infancy at a mean age of 6.5 months (range, 90 days to 8.5 months). All patients younger than 1 month of age underwent circumcision while fully awake using a dorsal penile nerve block. Patients greater than 3 months of age were circumcised under general anesthesia. Gomco circumcision was performed using 1.1- to 2.1-cm bells. Patients were assessed with regard to outcome. Results: None of the 98 patients in the early infancy group had postcircumcision complications. Of the 32 patients in the older group, 12 (30%) had postoperative bleeding requiring suture repair or fulguration. The skin edges separated in 2 patients, 1 less than 1 month of age and 1 in the older group. Neither patient required further intervention, and both healed spontaneously. There was no correlation between size of clamp and development of complications. Conclusion: Although safe and effective for circumcision in the neonatal period and in early infancy, use of the Gomco clamp for circumcision beyond early infancy (3 months of age) has substantial morbidity, and alternative methods of circumcision should be sought. J Pediatr Surg 36:1047-1049. Copyright © 2001 by W.B. Saunders Company.

Pain management for neonatal circumcision.

Circumcision is the most common surgical procedure performed in the neonatal period in North America. If untreated, the pain of circumcision causes both short and long term changes in infant behaviours. The most widely studied pharmacological intervention for pain management during circumcision is dorsal penile nerve block (DPNB) by injected lidocaine (lignocaine). Randomised controlled trials have demonstrated its efficacy; infants premedicated with lidocaine have significantly smaller changes in physiological and pain-related behaviours compared with infants who are not given analgesics. A meta-analysis of injection-related adverse effects (bruising/haematoma) yielded a risk of 6.7% (95% confidence interval, 0.5 to 12.9%). Systemic toxicity from injected local anaesthesia has not been reported. Less effective modalities include topical anaesthesia with lidocaine-prilocaine cream [Eutectic Mixture of Local Anaesthetics (EMLA)], lidocaine cream and oral administration of sucrose. The good tolerability of lidocaine-prilocaine cream has been demonstrated by a lack of clinically significant methaemoglobinaemia when used appropriately. Nonpharmacological interventions (pacifier, specially designed restraint chair) reduce distress during the procedure, and paracetamol (acetaminophen) may provide postoperative analgesia. No single agent has been demonstrated to ameliorate pain for all infants undergoing circumcision. A multimodal approach of pharmacotherapy is currently recommended. Studies evaluating the efficacy of combined analgesia have demonstrated significant benefits for combinations of 2 or more forms of treatment (such as DPNB and sucrose-dipped pacifier) compared with single interventions. The instrument used to perform the circumcision is also important. The Mogen clamp has been shown to be associated with a shorter procedure time and less pain compared with the Gomco clamp. If circumcision is to be performed on infants, it is, therefore, recommended that combined analgesia and the Mogen clamp technique are used, and nonpharmacological stress reducing interventions such as pacifiers and comfortable restraining chairs should also be employed.

Genitourinary injuries in the newborn

Circumcisions and cesarian sections are common procedures. Although complications to the newborn child fortunately are rare, it is important to emphasize the potential significance of this problem and its frequent iatrogenic etiology. The authors present 7 cases of genitourinary trauma in newborns, including surgical management and follow-up. The authors relate 7 recent cases of genitourinary trauma in newborns from a children's hospital in a major metropolitan area. Case 1 and 2: Two infants suffered degloving injuries to both the prepuce and penile shaft from a Gomco clamp. Successful full-thickness skin grafting using the previously excised foreskin was used in 1 child. Case 3, 4, and 5: A Mogen clamp caused glans injuries in 3 infants. In 2, hemorrhage from the severed glans was controlled with topical epinephrine; the glans healed with a flattened appearance. Another infant sustained a laceration ventrally, requiring a delayed modified meatal advancement glanoplasty to correct the injury. Case 6: A male infant suffered a ventral slit and division of the ventral urethra before placement of a Gomco clamp. Formal hypospadias repair was required. Case 7: An emergent cesarean section resulted in a grade 4-perineal laceration in a female infant. The vaginal tear caused by the surgeon's finger, extended up to the posterior insertion of the cervix and into the rectum. The infant successfully underwent an emergent multilayered repair. Genitourinary trauma in the newborn is rare but often necessitates significant surgical intervention. Circumcision often is the causative event. There has been only 1 prior report of a perineal injury similar to case 7, with a fatal outcome.

The first cut is the deepest? Medicolegal aspects of male circumcision.

The first cut is the deepest? Medicolegal aspects of male circumcision.

A model for teaching newborn circumcision.

Hundreds of residents are trained to perform neonatal circumcision every year. This article describes the construction and use of a model designed to introduce trainees to neonatal circumcision using the Gomco technique. A circumcision model was constructed using a clipboard, a pacifier, examination gloves, a rubber band, a syringe, tape, surgical towels, and a circumcision kit containing a 1.3 Gomco clamp, hemostats, surgical scissors, and a scalpel blade. With each trainee using a separate model, one instructor was able to guide four interns through three simulations each during a 1-hour orientation session.

Safer circumcision in patients with haemophilia: the use of fibrin glue for local haemostasis.

To evaluate the efficacy and the reduced costs of factor concentrates in circumcision by using fibrin glue in patients with haemophilia. Eleven patients with haemophilia (age range 6-14 years, 10 with haemophilia A, one with haemophilia B) were circumcised using fibrin glue for local haemostasis and to reduce the duration of clotting factor replacement after surgery. Circumcision was carried out under general anaesthesia; the prepuce was incised circumferentially and excised using the Gomco clamp technique. Haemophiliac patients were divided into two groups: in group 1 (four patients, three with haemophilia A and one with haemophilia B) the factor levels were assessed every 8 h and bolus injections of factor repeated during the first 4 days after surgery; in group 2, the seven remaining haemophilia A patients received a postoperative bolus injection and approximately 4 U/kg per hour of factor substitution for the first 2 days after surgery by continuous infusion. Eleven other patients with haemophilia A underwent circumcision using same surgical procedure but were given only factor substitution without fibrin glue, and served as a control group (group 3). None of the patients had significant bleeding or complications. The total costs were significantly reduced, to $8898 per patient in group 1 and $4866 per patient in group 2, when compared with $12875 per patient in group 3 (both P<0.05). Fibrin glue is a useful treatment for circumcision in patients with haemophilia; it lessens the need for factor substitution after circumcision and thus reduces the high cost of treatment.

A randomized, placebo-controlled comparison of EMLA ™ and dorsal penile nerve block for pain relief during neonatal circumcision

Objective: To evaluate the relative efficacies of eutetic mixture of local anesthetics (EMLA ™) cream and dorsal penile nerve block (DPNB) for pain relief during neonatal circumcision. Methods: After parental informed consent, appropriate-for-gestational age, term, healthy newborns were randomized to receive either EMLA cream and placebo saline DPNB or placebo cream and 1% lidocaine DPNB. Placebo and EMLA cream were prepared by the pharmacy and applied by study nurses. Preloaded syringes of saline or 1% lidocaine were also prepared by the pharmacy for the DPNB injections. This ensured blinding of the surgeons and assistants at the time of circumcisions. Circumcisions were performed with the Gomco clamp technique by one of three obstetrics and gynecology residents. Pain levels were assessed by measuring pulse and respiratory rates and determining Brazelton states at each step of the circumcision. Videotapes were made of each procedure to allow later scoring by a single blinded observer for Brazelton states. Brazelton state scores increase with increased infant pain and distress, as do heart and respiratory rates. Means were compared by t test and proportions by χ 2. A P value of .05 was considered statistically significant. Results: A total of 60 infants were randomized, 29 to DPNB and 31 to EMLA. Preoperative Brazelton state scores, heart rates, and respiratory rates were similar in both groups. Brazelton state scores were lower in the DPNB group at each step of the procedure—injection, dissection of the foreskin, clamp placement, and clamp removal—and postoperatively and overall, but the differences only reached statistical significance during dissection and clamp removal. Heart and respiratory rates also were lower at all surgical steps in the DPNB group but only reached statistical significance during postoperative observation. Conclusions: Although both EMLA and DPNB have been shown in other studies to decrease pain during neonatal circumcisions, DPNB has greater effectiveness in relieving the pain of circumcision.

Partial Amputation of Glans Penis During Mogen Clamp Circumcision

Although no numerical data are available, the most common techniques for performing newborn circumcision in the United States involve the use of the Plastibell, the Gomco clamp, and the Mogen clamp, likely in that order. The Mogen clamp (see Fig 1 and 2) is the least familiar to most pediatricians. It has a number of advantages when compared with the other techniques: 1. the one size of the Mogen fits all; 2. it is the most rapid; 3. the Mogen instrument allows full visualization of exactly how much prepuce to remove. In Mogen circumcision however, the glans is not visualized before removal of the prepuce.

Topical Anesthesia During Circumcision in Newborn Infants

To determine the efficacy of topical anesthetic cream, eutectic mixture of local anesthetics (EMLA), in alleviating pain from neonatal circumcision. Randomized, controlled trial. Normal newborn nursery in a university teaching hospital. Twenty-seven newborn, full-term male neonates, aged 1 to 3 days. Heart rate, transcutaneous oxygen saturation, facial activity, and crying. Compared with baseline, all newborns experienced pain as evidenced by increased heart rate of an average of 40 beats per minute (F [8, 25] = 14.12; P < .0001), decreased oxygen saturation of 3% (F [8, 25] = 15.02; P < .0001), and more facial actions indicative of pain (F [8, 25] = 5.25; P < .002) during all phases of the procedure. Compared with placebo, EMLA significantly attenuated the pain response as shown by lower heart rate of an average of 25 beats per minute (F [1, 25] = 14.92; P < .001), higher oxygen saturation of 5%, particularly during the clamping and lysis phases (F [1, 25] = 19.83; P < .0001), 20% less facial activity (F [1, 25] = 12.01; P < .002), and 15% less crying during the clamping, Gomco clamp application, and incision of the foreskin. There were no differences between groups in the spectral crying parameters. Circumcision procedure produces pain responses that EMLA diminishes. Thus, EMLA may be a useful agent for pain management in neonatal circumcision.

Circumcision: Refining a traditional surgical technique

Circumcision is a practice that dates back to the Stone Age, when flint knives were used to perform this delicate task. Since that time, different implements and techniques for their use have been employed. In 1935, an instrument that reduced the incidence of hemorrhage and infection, which continued to complicate circumcisions, was first described in the medical literature of this country; for nearly 60 years, the Gomco clamp has met and exceeded expectations despite the emergence of other clamps and devices. This article addresses refinements that have evolved in the Gomco clamp technique. These refinements combine the highest degree of safety with the least trauma to the newborn. Step-by-step detailing of this surgical skill and implications for practitioners are explored in depth.