Although in the last decades many authors have advocated the use of topical steroids as an alternative treatment of phimosis (1-3), with success rate ranging from 67 to 90% (4 5), circumcision is still the “gold standard” treatment for phimosis, and although not always performed for medical reasons, it is one of the most frequently performed surgery around the world (6). Circumcision is one of the oldest surgical procedures performed today and in the majority of time done in younger children.
Many techniques have been described for the treatment of phimosis and there is no consensus which procedure has better results. Besides dissection surgery and prepucialplasty, many devices have been used, such as Gomco Clamp, Mogen Clamp and plastic devices (6), and recently a novel plastic clamp have been described (7). The first two are used more often for neonates. Plastic devices although more frequently used in the first year of life can also be applied to older children, being an alternative technique for circumcision in this population. Plastibell® device has been first reported for circumcision in 1956 (8) and since then there has been a widespread of the technique with satisfactory results (9-12) although there are some reports showing severe complications with its use (13 14).
Most of the studies on Plastibell® circumcision are related to its complications. We found few reports on the time for separation of the plastic® device and none regarding its relationship to the age of the child and found no reports correlating the size of the glans and diameter of the device. Recently, Samad et al., 2010, published a series of circumcisions with Plastibell® device showing low complication rates (15).
Herein, we describe our experience with the use of Plastibell® device, demonstrating its relationship with the size of the glans and correlating the age of the child with the time for separation of the Plastibell®, and complications.
MATERIALS AND METHODS
This is a prospective consecutive series of 119 children older than two years of age and with medical indication for circumcision, operated using a plastic device (Plastibell®), by the same surgeon at University Hospital of the Federal University of Juiz de Fora, Brazil, from December 2009 to June 2011. The study protocol was approved by the hospital ethical committee and all parents of the involved children signed an informed consent. After evaluating the child, the indication for surgery and Kayaba's classification of the prepuce (16) were recorded.
All surgeries were performed under general anesthesia with dorsal penile block (17). After the anesthesia, the foreskin was completely retracted freeing the adhesions from the glans and the length of the penis under maximum traction and diameter of the glans were measured. Children with lateral-lateral diameter of the glans that a Plastibell® device could not be placed were not included in the study. The duration of the circumcision was recorded, initiating after the penile block and finishing after the dressing was done. In all children the frenulum was sectioned with electric cauterization.
The surgical technique applied was as follow: after sectioning the frenulum, the foreskin was pulled up and the Plastibell® device placed between the prepuce and the glans. The size of the device was chosen according to the size of the glans. A non-absorbable string was tightly tied around the device and the prepuce distally to it was excised. Dressing was made with bacitracin cream and a gauze covering it (12).
After waking from anesthesia the patients were sent home with the prescription of paracetamol to be used every 6 hours on the day of surgery and only if necessary on the following days. Parents were told to write down in a proper sheet how many times they gave the medicine each day for the first three days separately and then, if there was still need for the medication, after those three days until the first post-operative clinic visit. Follow-up was done in days 15, 45 and 90 after surgery. After Plastibell® separation all parents were oriented to do a repetitive traction of the prepuce twice a day to avoid adhesions and retraction of the surgical scar. The date of separations of the plastic device was recorded as well as the immediate and late post-operative complications.
Categorical variables were described by their absolute values and proportions, while numeric variables were described by median and interquartil range or means and standard deviation as appropriate. Correlation between quantitative variables was verified through Pearson's coefficient estimative. The unpaired t test, Mann-Whitney, ANOVA or Kruskall-Wallis tests were used to compare continuous variables while categorical variables were compared using the chi-squared or Fisher's exact test. All tests were two-sided, and p values < 0.05 were considered significant. Statistical analysis was performed using the GraphPad Prism 5.03 software. (San Diego, CA, USA).
The mean age of the boys was 5.9 ± 2.9 (range 2 to 12.5) years. The mean length of the penis was 7.3 ± 1.1 cm (3.9 to 11 cm) and the mean lateral-lateral diameter of the glans was 1.4 ± 0.2 cm (1.1 to 1.9 cm). All children with indications for circumcision were included in the study.
|Kayaba Classification||Number of Boys|
|Complain of Disconfort or Pain||51|
|Urinary Tract Infection||15|
|Hydronephrosis and Reflux||4|
The mean surgical time was 3.7 ± 2.0 minutes (1.9 to 9 minutes). The use of pain medication decreased along with time for the first three days after surgery. In the first day after surgery 57.1% of the boys needed at least one dose of paracetamol, on the second day, 37.8%, on the third day 24.4%. After the third post-operatory day we found a little increase on the use of the pain medication with 32.6% of the patients needing at least one dosage of paracetamol.
The overall mean time for Plastibell® separation was 16.2 ± 4.2 days and this time correlated with age of the children. As younger the boys, the shorter the time for the plastic device to fall off (r = 0.367) (p < 0.001) (Figure-1). Similarly, when divided into two groups, we observed that in those less than five years of age, the median time was three days lower than in older children, respectively, 14 [12-18] and 17 [14-20] days (p = 0.011). In the other hand, the diameters of the plastic device were not a predictor for earlier fall (p = 0.484) (Figure-2).
Immediate complications occurred only in 7 boys (5.9%) and were hemorrhagic in 3 patients, one of them needing to return to the operating room for review and suture of the foreskin (conversion to dissection technique). The other two had only a small hematoma that resolved with local compression. Three boys had severe edema of the prepuce after circumcision that also resolved spontaneously, and one boy had urinary retention for more than 12 hours but ended up voiding spontaneously, with no need for bladder drainage.
Late complications occurred in 32 (26.8%) and most of these were with low clinical significance. The most frequent late complications were post-operative adhesions of the prepuce to the glans, which occurred in 18 (15.1%) boys. Four boys (3.4%) presented with a fibrotic scar forming a constrictive ring on the prepuce, which resolved with topical steroid (0.1% mometasone fuorate). One of them had paraphimosis that resolved with manual reduction. Three boys (2.5%) had severe edema of the prepuce that resolved spontaneously. There was one case of meatal stenosis in a boy still in diapers that needed meatoplasty. One boy had late bleeding due to a crust where previously was observed an adhesion. Complications related directly to the Plastibell® device occurred in only 6 (5.4%) boys. Five of them complained greater pain on the days proceeding the fall off of the plastic device and in only one case the Plastibell® device was retained and needed manual removal, which was done as an office procedure with no need for anesthesia (Table-2).
|Complications||Number of Patients (%)|
|Early Complications||7 (5.8%)|
|Urinary Retention||1 (0.8%)|
|Late Complications||32 (26.8%)|
|Pain for device expulsion||5 (4.2%)|
|Fibrotic scar (constrictive ring)||4 (3.3%)|
|Edema of Prepuce||3 (2.5%)|
|Meatal Estenosis||1 (0.8%)|
|Late bleeding due to crust||1 (0.8%)|
|Plastibell® retention||1 (0.8%)|
The complication rates did not correlate with the size of the devices and were similar in the two age groups (p = 0.782) (Figure-3).
Routine neonatal circumcision has been previously contra indicated by the American Academy of Pediatrics (AAP) (18 19), although in recent publication they advocate that evidences indicate that the health benefits of newborn male circumcision outweigh the risks; furthermore, the benefits of newborn male circumcision justify access to this procedure for families who choose it (20). In our country, neonate circumcision is rarely indicated and most of the children are operated due to medical indications or willing of the parents, usually after they are off diapers, therefore we circumcise our children in an older age. The mean age in our group of patients was 70.86 months (5.9 years of age), corresponding to an older age compared to the majority of studies published on plastic device circumcision (9 11 15 21 22). In the study of Marwat et al., 2010 (22), 83% of the children were younger than one year of age and had fewer complications than the older children (between 1 and 5 years old). Their overall complications were 2.5% for younger children and 21.21% for older children.
The use of plastic devices for circumcision is not accepted by many authors specially due to reports on complications associated with it (9 14 23-26). Although we present a series of only 119 boys we had no serious complications. Only 5.88% of the boys presented immediate complications, being two hematomas that resolved with local compression and two edemas of the penis and prepuce, most probably related to the anesthetic puncture for the penile block and that also resolved spontaneously. Another boy had urinary retention but ended up urinating after 12 hours and was due to fear of urinating, and not an obstruction by the device. The most severe immediate complication we observed was one boy that bled due to dislocation of the plastic device right after the surgical procedure. This boy needed to be sent back to the operating room to remove the device and conversion to a dissection circumcision suturing the prepuce. The incidence of early complications in plastic device circumcision have been reported by our group to be similar to those of dissection circumcision (12).
Marwat et al., 2010, evaluating 780 children submitted to plastic device circumcision described only 1.51% hematoma and 2.27% of bleeding in children between 1 and 5 years of age (22). In another study by Sörensen & Sörensen, 1988, hemorrhage was present in 5% while dysuria was described in up to 56% (27). A low incidence of immediate complications was also reported by Samad et al., 2010, with 0.2% of bleeding and 0.2% of urinary retention (15). Bleeding was also the most common early complication with only 3% of children in the study by Palit et al., 2007 (21). If in our series we excluded the edemas, which were caused by the local anesthesia puncture, and urinary retention, that resolved spontaneously, we would have only 2.5% complications which were all hemorrhagic. Bleeding usually occurs due to inappropriate tying of the string around the device, predisposing to a displacement of the plastic ring with retraction of the inner prepuce, which leads to release of the compression over the prepuce vessels and consequent hemorrhage. A careful placement of the plastic device, observing the position of the inner prepuce and a tight ligature is mandatory in the prevention of these complications. Another possible early complication, urinary retention, has been reported as caused by constriction of the urethra by the device in neonates (28), which occurs by an incorrect selection of the size of the plastic device which was not the case in our child that had urinary retention.
Plastic device circumcision can be done in a very short period of time (mean: 3.7 ± 2.0 minutes) with low trauma to the prepuce and penis. This surgical time is significantly shorter than dissection circumcision as we have previously demonstrated (12). Post-operative discomfort and pain were rare and the use of pain medication (paracetamol) was low in the first days after surgery and increased in the two days proceeding the fall off the device. This occurs due to the edema and inflammatory process related to necrosis and expulsion of the plastic ring.
Late complications were present in 32 children (26.8%) being most of them not of serious consequences. There was only one case of meatal estenosis needing meatoplasty and one boy who presented with paraphimosis due to a tight scar that after manual reduction and use of topical steroid had complete resolution. The most frequent late complication was adhesion of the prepuce to glans, that occurred even with all parents being oriented to retract the prepuce after the fall of the plastic device. This is related to previous adhesion, and was left untreated because it is known that it resolves with time (29). Many authors would not report this fact as complication. If we excluded those boys who had adhesions the complication rate will decrease to 11.7% and also those who suffered from pain prior to the fall of the device the rate of late complications decreases even more to 7.5%. We have previously shown that adhesions are most common in patients submitted to circumcision with the sleeve technique than to plastic device (12).
Only 4.2% percent of the boys complain of greater pain during the process of falling off of the plastic device and we had only one Plastibell® retention, that was removed manually and as an office procedure, different from the majority of series in which retention of the device was the most frequent reported complication (11 15 21 22 26). These findings go against those contrary to the use of plastic device in older children, whose arguments are that it has a large rate of impactions, which was not found in our study with patients up to 12 years of age.
The complications described herein were not correlated with the size of the plastic device, therefore one may speculate that as long the right size of the ring is chosen the chance of complications is the same for each diameter of Plastibell®.
Observing the facts that were involved in Plastibell® separation we found that only the age of the patients were related to it. When analyzing this group of 119 boys we noted that the separation occurs in a shorter time in younger boys and as the children grow older the time for separation increases. If we divide the boys in groups by age we can observe that in those younger than 5 years of age the device would fall in a shorter time (mean of 14 days) than those older than 5 years of age (mean of 17 days), which is similar to that reported by Samad et al., 2010, who observed a period of 16.8 days for the Plastibell® separation in children older than 5 years of age and 8.7 days for children younger than 3 months of age (15). Although the size of the penis and, therefore, a small necrosis area could be a reason for a shorter period for separation of the device, we found no correlation between the size of the Plastibell® and time for separation. These observations induce to a thought that it's not the size of the plastic device but the age of the child that has the greatest influence in this process. As younger the child, the thinner and softer is his foreskin and this may facilitate the scarring process and allows an earlier separation of the Plastibell®.
There are some limitations to our study. Although we evaluated a large series of boys (119), our series is shorter than the majority of series reported in the literature. We also did not report on the aesthetical aspects of the prepuce after surgery, however cosmetics is something personal and we had no complains from the families.