Implementaci´on de las acciones

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CHAPTER SIX

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The cases circumcised with PB were complicated than those done with DPD. In the PB group 10.2% were complicated while in the, DPD group, 5.8% had complications The figures for both devices still fall within the range of what Kapilla²⁰ quoted in his review (0.067% - 55%). However, in this study, there was no significant difference between the frequency of complications following the use of the two devices.

The two commonest complications in this study were infections and ring dislocations in each of which 6 cases were recorded out of 25 complications each representing 24 % overall, whereas haemorrhage was rated as the commonest in most series from various techniques.3, 29, 53, 56, 59, 60, 62, 63, 67, 100 This is probably because PB and DPD device methods were designed to enhance bloodless circumcision. ^{27, 62} Three cases were infected in each device group. All the infected cases were neonates. This could have been aggravated by the extensive dissection involved in the separation of the physiological phimotic adhesions prior to the eventual application of the device.

The ischaemic injury and possibly the foreign body reaction induced by the presence of a rigid structure attached to the raw surface of circumcision wound produced erythema and swelling which looked like superficial infection. Cultures done in infected cases yielded staph aureus, staph epidermidis and E. coli which are similar to those reported by Badejo⁵³ in Ile–Ife where mixed coliforms and skin contaminants were isolated.

However, serious infections with major associated problems like scarring or keloids^{20, 69} with deformity, paradoxic phimosis, major skin lesions, staphylococcal scalded skin syndrome,²⁰ and generalized sepsis-¹ fournier gangrene,⁶⁹ necrotizing fasciitis,⁷¹ osteomyelitis,²⁰ meningitis,⁷⁰ tetanus^{2, 57, 59} and death^{1, 11, 59} were not recorded in this study.

Three cases of ring dislocations were seen in each device group. The incidence in this study was much higher than recorded in the Saudi series by Al-Salmarai et al ²⁹ in which only 0.15 % had this complication. The difference here might have been accounted for by the introduction of a new device (DPD in addition to plastibell in this study).

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In Injudicious fitting of inappropriate size of device (too small or too large) coupled with excessive pull of the skin before ligature could have led to proximal or distal dislocation of the ring. When displaced proximally, the tight ring impairs venous return and leads to penile oedema and has to be cut with bone cutting forceps. When the ring migrates distally, the ring fails to separate (ring retention) till the unnecrosed skin tag is excised with scissors. Penile oedema occurred in 5 of 313 cases, all of hich were from plastibell circumcision. This represents 3.18% of PB circumcision but 20% of all complications during the study period. In all, the oedema subsided few days after the device ring causing penile obstruction dropped off. There were 3 cases out of 313 cases in this study that were complicated by post-circumcision bleeding, 2 from plastibell and one from DPD. Although haemorrhage has been reported as the commonest complication encountered in 0.1- 35% of circumcisions ²⁰, the relative percentage in this study was similar to that of the same complication reported in the Lagos series by Bode and Kene-Ewulu¹, though their subjects were all referred , representing ‘a tip of the iceberg’.

The overall incidence of haemorrhage in this study is consistent with other figures of 0.7 – 2% of bleeding cases requiring doctor’s intervention. ^62-64 This seemingly low incidence despite the introduction of the new device along with the use of the well-acclaimed PB reaffirms the fact that the two similar devices are designed to enhance bloodless circumcision when properly used.

Since all those that had this complication in this study were neonates, it is possible that bleeding must have been aggravated by post-natal decrease in thrombin, reported by Badejo in Ile-Ife. ⁵³ And Ahmed et at in Zaria.⁵⁹ However, there was no significant difference in the means of the bleeding time and clotting time for those who bled and those that did not. This implies that the cause of this complication must have been technical rather than haematological. Bleeding in these neonates could therefore have been related to the traumatic dissection of the physiological phimosis prior to the application of the device.

In the Saudi series ²⁹, bleeding occurred in most instances because of improper tying of the ligature and application of wrong sized device which often slips post-operatively leaving the raw edge of the amputated prepuce to bleed freely.

Two cases of PB bled as against one of DPD. The wide groove on the PB ring might have permitted easy slippage of ligature. Ligation of the bleeding vessel or application of

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another ligature were the main measures employed to control bleeding especially if an over-sized bell was used. In two of the three cases (one in each device group), the technique was changed to the conventional method after Ligation of the bleeding vessel (s), the other

one case of PB had another ligature applied to stem the bleeding.

Inadequate circumcision evidenced by the presence of redundant skin was recorded in 2 of the 255 neonates. Both resulted from DPD circumcision. All these figures, regardless of their respective denominators, were much less than those reported from the Lagos study¹ which reported 19 of their 90 series with this complication, 10 of which were from plastibell while the remaining 9 were from open method. However, all their cases were referred by various circumcisers. The seemingly exclusive occurrence of this complication in association with DPD use in this study is not surprising because the presence of a removable handle in the PB device facilitates correct traction of the foreskin for application of ligature before trimming of the prepuce. This complication was not seen in older newborns probably because their prepuce is retractably loose and handy for easier placement of the bell and ligature. However, with experience, exact placement of the ligature and the bell can be achieved.

Singularly seen in the neonates in this study also were 2 cases circumcised with PB complicated by the preputial skin bridging. This complication is not peculiar to any method but directly related to the traumatic dissection of the physiological phimosis in neonates which could have provoked formation of adhesive bands (scars) across the coronal groove, due to fusion of the shaft skin with that of the glans. ⁷² Bode and Kene-Ewulu¹ reported 22 cases of skin bridge out of 90 referred post-circumcision complications. Six of them followed circumcisions with Plastibell by doctors. Of the remaining 16 circumcised by open method 11 were done by doctors and 5 by nurses. The variance in the figures could probably be accounted for by different techniques and operators at different settings in the Lagos study compared with the present work.

One older newborn circumcised with PB had shaft denudation. It is possible that the presence of removable handle in PB device can facilitate overzealous traction of foreskin to be tied especially when the prepuce is loose as in older newborn. After the ring has separated, the over-stretched shaft skin slides back leaving a denuded penile

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shaft. The skin loss in this baby was however not extensive. With frequent saline dabbing, the skin regenerated without excessive scar or deformity. The fact that most of the above complications were amenable to simple genital hygiene treatment emphasizes the importance of continuing penile care in the circumcised newborn.

Other complications not encountered in this study but already reported elsewhere with PB device use for circumcision include^.

Circumcision of the hypospaedias⁵⁰ Urinary retention.⁵⁴Bi-valving of the urethra ^1,

60 Excavated frenulum⁷² Urethro-cutaneous fistulae^{53, 56} Ablation of the penis²⁰ Penile gangrene^{69 Buried} penis⁴⁶ Tetanus ^{2, 51} Death ^{1, 11, 59}

Parental satisfaction

This must have been negatively influenced by the frequency and severity of complications with the associated cosmetic implications. Concerned parents got worried when the circumcisions of their male newborns were complicated by bleeding which tends to scare them, or redundant skin, when the circumcised penis did seem to look like that of the father. Furthermore, failure of the ring to drop off (ring retention) also causes cultural embarrassment.

Most parental dissatisfactions stemmed from redundant skin due to inadequate circumcision or from loss of coronal differentiation due to excessive excision of the inner preputial membrane.⁶⁰ report from a previous studies by Ferguson et al⁸⁸ indicated that 2.8% of parents will complain of cosmetic appearance. Similarly, in this study, 2.9% of parents overall were not satisfied with device circumcision. Virtually all the cases recorded with complications that are related to parental dissatisfaction were neonates while there was only one older newborn from DPD group. Parental satisfaction was comparably good with both device circumcision methods. Most parents were eager to recommend the future use of the devices for circumcision.

cxvi Cosmetic outcome.

Care was taken not to rely on parental assessment of cosmetic outcome because most parents do not have any idea of what the well-circumcised penis should look like.^72,86 In most instances they rely on whatever the operator or the doctor must have told them. To avoid bias independent assessors unaware of the specific method for specific male newborns were recruited to assess this. The overall cosmetic outcome from PB and DPD were comparably good across age groups and there was no significant difference between the cosmetic outcome of the two devices.

The figures for cosmetic outcome were higher than those of parental satisfaction and complications because some of the complications which were mild and amenable to simple treatment, are the resolved with good cosmetic outcome before eventual assessment for cosmetic results.

Documented complications that were associated with cosmetic implications include redundant skin, phimosis, buried penis,⁷⁴ scarring, keloids, excavated frenulum, cysts and glanular amputation. Out of these, redundant skin, phimosis and buried penis may necessitate circumcision revision. In series of consecutive circumcision in Australia, Leitch⁸¹ found that in 99.5% of patients the operations had to be repeated in 11 for phimosis, 7 for redundant skin and 1 for paraphimosis. MacCarty et al⁸⁸ In a study from the UK reported that in one percent of patient the circumcision has to be revised because of inadequate skin excision at the initial, procedure. In this study, one of the 2 neonates with redundant skin had circumcision revision done, the other was mild and easily retractable with satisfactory cosmetic outcome. The figures from this stusy can not be compared with any known study in the available literature because specifics about the interpretation of normalcy in the appearance of the circumcised penis are not well documented.

Cost

Procedure Time

In this study the overall mean procedure time for circumcision with PB was 8.12  SD minutes, while that of DPD was 8.3  SD minutes. The mean procedure time for PB in neonates was 489.6  187.6 sec. while that for DPD was 505.1  229.5 sec. However,

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inolder male newborns, the mean procedure time for DPD was 454 173.3 sec. while that for PB was 475  1825 sec with no significant difference between the value for the two devices in both age groups.

Few studies report on the procedure timing of newborn circumcision. Kariher and Smith²⁷ who introduced the use of plastibell for immediate circumcision of the male newborns, claimed that plastibell circumcision did not last more than 3 minutes in their hands. The findings in this study is similar to that of Marshal et al in 1980 ⁹⁹, for Gomco clamp circumcision which was 7.6 1.8 minutes: the results of which were comparable to that of PB in convenience, speed of procedure and complications⁶² The plastibell procedure like that of Gomco take 10 to 12 min. or more to complete^{108, 112} The suggested procedure timing from the usage instruction of PB is probably accounted for by the two minutes waiting time allowed for the crushing effect before the dorsal slit is made.

However the use of Mogen clamp for circumcision has been reported to be swifter than them all lasting about 30 seconds^.109

Duration in days for device ring to drop off

Separation of the PB ring occurred at a mean of 4.2, .0.53 days for PB and 4.10  0.36 fro DPD in the neonates. In the older newborns, separation of the ring occurred at a mean of 4.00 days in PB but 4.3 0.75 days in DPD. A difference of 8 hours can impose a lot of discomfort in the helpless circumcised male newborn. implying that DPD took longer time to use for circumcision of older newborns than PB. However, the number is too small to draw a valid conclusion there from. The overall, average number of days for PB ring to drop off was 4 days and that of DPD being 4 days, 3 hours 6 minutes to drop off. These figures are very close to the findings of Kariher and Smith²⁷ in which the plastibell ring separated between 5 and 7 days.

The earliest time in days for separation to occur in this study was 3 days for both devices. In no case was a retained ring ever allowed in this study, to stay beyond 7 days before they were removed either by cutting the device with a bone cutter or excising the unnecrosed skin tag skin with scissors not only to comply with the manufacturer’s ¹⁰⁹ recommendation but more so, to avoid cultural embarrassment. In this study, 6 cases (3 in each device group, five neonates and only one in older newborns) were retained either

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because of proximal or distal dislocation of the ring. It is not unlikely that some of the previous authors had not complied with the manufacturer’s recommendation that the ring will separate within one week.¹⁰⁹

Robenstein and Baron⁷⁷ were still expectant that the plastibell ring would slough off after 10 - 12 days while Frazer et al ⁶³ did not consider the plastibell ring retained till after 9 days. The present author was wary of the unpleasant appearance of the circumcised penis with attendant risk of glanular oedema with or without cyanosis and possibility of necrosis, infection, gangrene and urethral stenosis that could result from prolonged midshaft constriction and so, did not risk allowing the ring staying beyond seventh post-operative day especially when patients’ return for follow-up can not be guaranteed.

Cost of Procurement/Production of the device.

The new device costs much less It costs about 33.3% the price of PB ( (N50 vs N150) to procure. Awojobi in Eruwa¹¹³ fabricated hospital equipment that cost 10% of the imported brands. The cost of DPD is likely to be cheaper still if produced on a large scale.

It is also not deformed by autoclaving or boiling because the synthetic material in the syringe (polypropylene¹⁰² ) has a higher heat, chemical and electrical resistance than butyrate²⁸ in P .

In this study, virtually the same benefit was realized when DPD was comparably used for newborn circumcision with the well-acclaimed plastibell but at a lower cost. This agrees with WHO’S statement on cost containment in 1975 ¹¹⁰ that the valid objective of saving health costs is to realize the same benefits at lower cost and to increase benefits without adding costs. Providing health care is at a cost which is increasing in all nations and resources of most countries particularly developing ones are scarce. Moreover health has to compete with other needs for the scarce resources of individuals, communities and nations.

Akande’s ⁹⁴ reasons for inability of health needs to be translated into effective demands are lack of affordability, poor geographical accessibility, availability, non-acceptability and cost of time from work with cost of waiting.

Medical cost was one of the major reasons advanced by Ademuwagun ¹¹¹ for poor utilization of health facilities in western Nigeria. It is no gain saying that the only health

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service that can be expected to reach the entire population especially in the developing countries are those that are of low cost.

It is not unlikely therefore that the sharp decline in the number of circumcisions in recent years in Baptist Medical Centre Ogbomoso was probably due to the rising charges for the procedure just like it did occur in Ahmadu Bello University Teaching Hospital Zaria in northern Nigeria in recent years.⁵⁹ During this study period, male newborn circumcision with plastibell costs N 800 in BMC which is about four times the price charged by the cheapest untrained traditional operator for circumcision without anaesthesia in the same locality.

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LIMITATIONS OF THE STUDY

1. The study was fully carried out in health facilities and the procedures were performed by a single operator, the author, the findings might not be truly representative of all outpatients settings in our town where different health personnel routinely circumcise male newborns.

2. Complete accuracy could not be obtained in the design of the new device for circumcision.

3. Packed cell volume, serum bilirubin and coagulation test like PTT were not done for reasons of lack of facilities in the primary health centres in order to curtail cost.

4. Confounding factors like variation in time spent for the preliminary dissection of varying degree of physiologic phimosis before circumcision could have made the timing of the procedure inexact.

5. All retained bells or rings that failed to slough off were not allowed to remain in situ beyond seventh post-operative day before removal in order to avoid cultural embarrassment, hence the incidence of this complication might have been overestimated compared to other studies.

6. Due to service commitment of the author, it was not possible for him to conduct home visits in all cases. The service of home visitors and social workers were not evenly available in the various health facilities when the study was carried out. This explains why patients were still lost to follow-up.

7. That some parents did not come for follow-up can be extrapolated to mean that the circumcision of their wards were complication free, hence the incidence of complication in this series might have been overestimated while parental satisfaction and cosmetic results might have been under or overestimated.

8. The data collection for the project was completed since 1998, however, the write-up has been delayed because of some constraints some of which are:

(i) Dearth of appropriate literature on circumcision cosmesis and post-circumcision parental satisfaction.

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(ii) Initial approval from the originator of the DPD device; Dr. Sola Freeman which was verbal had to be renewed officially but at a time when he had left Nigeria for Australia before this project could be presented for examination.

(iii) Domestic contingencies.

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