MALE NEWBORN CIRCUMCISIONS IN OGBOMOSO: A COMPARATIVE STUDY OF THE USE OF DISPOSABLE PLASTIC DEVICE WITH THE STANDARD: PLASTIBELL
A prospective randomized trial of the use of a locally fabricated disposable plastic device (DPD) for newborn circumcision in comparison with plastibell was carried out at Baptist Medical Centre (BMC), Ibrahim Taiwo Maternity Centre (ITMC), and Alata Maternity Centre (AMC), all in Ogbomoso. Three hundred and twenty male newborns aged 8 to 60 days inclusive (mean 20.3 days) were randomly circumcised with either device and followed up over a period of 12 months, from 1st August 1997 to 31st July 1998 both dates inclusive.
Comparative studies were made with respect to outcomes and cost of the two devices (DPD and PB) for circumcision. For the outcomes of use, the frequencies of complications, parental satisfaction and post circumcision cosmetic outcome were considered while the procedure time, the duration in days for the ring to separate and the cost of procurement of the respective device were used as parameters for cost. Of the 320 male newborns circumcised, 313 were assessed for complications, 311 for parental satisfaction and 310 for cosmetic outcome and duration in days for device ring to separate.
The overall incidence of complications for both devices was 8 percent (25 of 313) or 80 per thousand male newborns.
More complications occurred with plastibell circumcision than with the new device (16 vs. 9) but not statistically significantly so. (P.05)
Complications were commoner in neonates (8 to 28 days old) than in the older infants.
Complications encountered were never serious and were amenable to treatment.
The complications in descending order of frequencies were infections (6), dislocation (6), penile oedema (5) bleeding (3), skin bridging (2), redundant foreskin (2) and one case of shaft denudation. One case of redundant skin resulting from DPD use had circumcision revision done.
Parental satisfaction with respective device used and post circumcision cosmetic outcome from both devices were comparably good across centres and age groups.
The mean procedure time for DPD was 7 min 34 seconds while that for PB was 7 minutes 55 seconds.
The mean duration in days for the ring to drop off for both devices was 4 days.
However, PB ring was found to drop off earlier in older newborns than DPD ring. P 05.
The DPD with its ligature cost N50 while PB kit cost N150 during the study period. Since the same benefit was achieved at lower cost when DPD was used for circumcision in comparison with PB the author hereby recommends adoption, modification and standardization of DPD construction technology for use in male newborn circumcisions. A call is made to paediatric urologists, plastic surgeons and family physicians world wide to draw out standardized specifics regarding interpretation of normalcy in the appearance of well circumcised penis at different age groups to continuously educate would-be circumcisers about the risks vis-à-vis the benefits of this simple but delicate surgery.
Title Page ……………………………………………………………………. ii
Declaration …………………………………………………………………... iii
Certification …………………………………………………………………. iv
Dedication …………………………………………………………………… v
Acknowledgement …………………………………………………………... vi
Contents ……………………………………………………………………… vii
List of Abbreviations ………………………………………………………… viii
List of Illustrations …………………………………………………………… x
List of Appendices …………………………………………………………… xii
Summary …………………………………………………………………….. xiii
Chapter One: Introduction ………………………………………………… 1
Chapter Two: Literature Review …………………………………………… 3
Chapter Three: Aim and Objectives ………………………………………… 41
Chapter Four: Patients, Materials and Methods ……………………………… 42
Chapter five: Results …………………………………………………………. 64
Chapter Six: Discussion, Limitations of study, Conclusion and Recommendation 92
CHAPTER ONE INTRODUCTION
Circumcision is the partial or complete surgical removal of the foreskin on the male genitalia.1 It is probably the oldest and most universal operation in the world,2 which evolved in ancient times as a religious or cultural practice3.
Attitudes to circumcision vary widely depending on the country and culture. In many cultures of North America, Middle East and West Africa, male circumcision remains the most commonly performed surgical procedure. While it remains a ritualistic surgery in many developing societies like Africa, however, newborn circumcision is not routinely practiced in Japan and Scandinavian countries4.
Male newborn circumcision consists of removal of the foreskin to near the coronal sulcus, performed in early infancy (before age of 2 months).5 It is quick and generally safe when performed by an experienced operator. The procedure is cheaper and avoids the risk of general anaesthesia to perform early in life rather than later. 6
The advantages of male newborn circumcision include; the prevention of penile cancer, balanitis, recurrent urinary tract infection and decreased risk of cervical cancer in female partners of circumcised men 5,7,8,9
The surgical technique of circumcision is not as controversial as the many existing different methods; with each one extolling the virtues of the procedure described. In order to reduce complication rates, new devices such as Gomco, Mogen and plastibell clamps have been designed over the method of open dissection, however, there is no method that is problem free.1
The Gomco clamp has been in use for many decades in Baptist Medical Centre before the introduction of Plastibell clamp into the centre in the 1980s, when it became the choice method of circumcision by many parents in BMC, Ogbomoso. However, the downturn in Nigerian economy made plastibell scarce and the procedure unaffordable (N800). Use of Gomco clamp soon displaced plastibell in BMC. Apparently cheaper it seems, the initial cost outlay for Gomco clamp is prohibitive.1 Moreover the use of Gomco clamp is technically more difficult 1.
When faced with similar problems, Dr. Shola Freeman, a private practitioner of many years of experience in Ilesa, Osun State of Nigeria had to devise a modification of plastibell, using a disposable plastic syringe. In Freeman,s practice, verbally though, several cases of newborn circumcisions he performed with the device did not produce any serious complication. The need now arises to compare the use of this new device for circumcision with that of the standard, the plastibell.
The result of the pilot study conducted by the researcher in BMC over a period of 4 weeks showed no serious complication in all the 24 cases of circumcision performed during the period.
In this research, the author described the design of the new device for circumcision and compares its use with that of plastibell with respect to safety, outcome and ease of use. This study is coming up at a time when quite a few prospective studies on circumcisions have been carried out from various parts of Nigeria most of which however, have not been able to relate specific complication with specific device.
It is hoped that the information gained will help family physicians and indeed all who are involved in the care of the male newborns to better understand the technicalities involved in circumcision; so that when adequately trained they can offer the procedure when indicated, even in rural or isolated settings of their practice. It is also hoped that it will stimulate further studies on circumcision at the local, regional or national level so that meaningful policies can be formulated based on objective internationally acceptable and reproducible data.
HISTORY OF CIRCUMCISION
Circumcision is probably one of the oldest of all surgical procedures, the origin of which is not entirely clear especially among the Black race. The Jews practised circumcision much earlier than the biblical account of Abraham.9 while among Arabs it has been in practice as early as 342 BC, many centuries before the time of Mohammed10. The Blacks probably embraced the custom of circumcision from the Arabs with whom they had trading connections along the East Coast of Africa.11
The practice of circumcision could have probably come through Hamitic sources to the Blacks since they are of Hamitic origin in part but in that case it would be natural to expect the custom to be universal among them which is not. The custom has been passed on to the neighbouring tribes from Xhosa, to the Thembu, Mfengu and Bomvana. In many cultures worldwide, circumcision is performed for social reasons 9,12 namely:
- To imprint pain into the newborn with a view to toughen his ability to survive the rigour of later life.
- For fertility rite.
- To defile slaves:It is believed that the Jews and Phoenicians who were largely enslaved, adopted circumcision as religious ritual from their Egyptian masters.
- As a mark of purity in the early church
Mark of tribal identity:- About 140 AD, circumcision procedure was modified to what is termed synectomy today, which leaves the glans much more exposed. The practice called
“periah” has been designed to make it impossible for a Jew to be mistaken for another race.
In the first century, Christians rejected circumcision at a council in Jerusalem, but today the Christian church has no specific doctrine about it except the Abyssinian church.10
In 1865, circumcision was reported in England, after which it became a therapeutic procedure for many ailments (Psychosexual problems, epilepsy, and night horror). Before then, no study was done to appraise the effectiveness and safety of the procedure.12 Koreans adopted the procedure from Americans during the America's period of trusteeship after the South Korean war in 1950. That same year, the British National Health service deleted non-therapeutic neonatal circumcision from the schedule of covered procedures following an earlier publication by Gairdner that circumcision was not only unnecessary, but too risky a procedure, for the child. Influenced by Dr. Preston's publication of 1970 the American Academy of Paediatrics (AAP) issued a statement that there are no valid medical indications for neonatal circumcision. Since then, incidence of neonatal circumcision in the U. S. began to fall continuously till date10.
Recently some policy statements of circumcision in some English speaking
countries include13: -
- Canada: - 1996: The Canadian Pediatric society issued a new evidence based policy statement which strengthened it’s 1975 policy statement declaring that circumcision should not be routinely performed.
Australia 1996: The Australian College of paediatrics (ACP) termed circumcision traumatic and a possible violation of human right.
Parents should be well informed about it before making a decision. The Australian Medical Association threw their support behind the ACP statement. In the same year Australian Association of paediatric surgeons advised that the procedure should rather be deferred till when the child is old enough to decide for himself so as to justify the complications and risks.
Britain 1996: Discouraged performance of medical neonatal circumcision especially when alternative, but less invasive and equally effective procedure is available.
- S. A. 1996: The circumcision information and resource pages "CIRP" were created in the Internet to provide accurate information about circumcision10.
The American Academy of Pediatrics (AAP), after series of review of the medical evidence, the task force concluded in 1999 that neonatal circumcision cannot be recommended because the benefits are only potential but, yet unproven.
In 2000, the council of scientific affairs of the American Medical Association reclassified circumcision as non-therapeutic procedure with possible medico-legal impact.
Male circumcision is practiced in many parts of Africa but there is wide regional variation. It is not abundantly practiced among the ethnic groups in Eastern and Southern Africa. These areas of non-circumcision cover most of Uganda, parts of Western Kenya,
Western Tanzania, northeastern Democratic Republic of Congo, virtually all of Rwanda, Burundi, Zambia, Malawi and Mozambique and South Africa. Circumcision is almost universally practiced in most parts of West Africa, including Nigeria. There is however, a large area of traditional non-circumcision covering central eastern Ivory Coast and western/Central Ghana14.
EVOLUTION OF NEONATAL CIRCUMCISION TECHNIQUE AND INSTRUMENTS
Early Jewish sources dealing with circumcision do not describe the procedure. 15 The Bible refers to sharp stones and flint knives used as circumcision instrument, but there is no description of the technique used. 17
The technique of circumcision is better described in the handbook for ritual circumcisers which came to be known as Sifrei-Ha Mohelim; .The prepuce was pinched with the thumb and 3 fingers of the left hand and drawn forward. With the double edged knife called “Izmel” held in the right hand, the prepuce was excised carefully without trauma to the scrotum. The mucosa was then torn along the dorsum and peeled back below the corona. After circumcision, the glans was forced through the hole of a therapeutic bandage made of an oil-saturated cloth with a central aperture. The rest of the bandage was tied around the penis. This helped to prevent formation of adhesion between the glans and raw skin edges.
Trauma was a major concern especially regarding the glans. Knives made of sharp reeds were specifically prohibited because of possible injuries from splinters. According to the biblical laws men with injured penis were restricted as to whom they may marry18,
In the middle of the 18th century reference was made to the use of flat shield in the
‘Responsa’ writings of Jacob Emden20. The shield was a metal plate with middle slit, which was forced into the stretched prepuce from front to rear, to protect the glans while the prepuce was excised.
Interestingly, Nuri – Bay Risa; a famous Turkish physician, at the turn of the 20th century mentioned that Muslims used to protect the glans by tying two strings around the stretched prepuce and cutting between the two knots.
In the same ‘Responsa’ writing of Jacob Embden, the probe was described. Its function was to separate the adhesions between the mucosa and the glans for easy excision of the mucosa with the prepuce.
In 1903, Sir Fredrick Treves 21 provided us with basic surgical principles that remained till today.
- The use of scissors to remove prepuce
- Mandatory ligation of frenular artery in the adult but not necessarily in the neonate because simple pressure can control bleeding in them.
- Avoidance of excessive removal of skin to prevent chordae.
- The use of interrupted (not continuous) fine gut as appositional suture of the skin edge.
Early circumcisions were all done “free-handed” (without clamps) and bleeding was a serious problem. Tight bandages were applied to control bleeding. However, bandaging the penis of a neonate for haemostasis is extremely difficult and requires great skill, so as not to cause urethral obstruction. More recently topical thrombin (thrombostat), epinephrine or oxidized cellulose, (oxycell) have been used.16
An early attempt to develop an instrument to avert bleeding was made by Moskovich22 in 1920 when he designed the circumcision forceps, which resembles a towel holder with seven indentations for suture. The forceps did not gain wide acceptance probably because of poor cosmetic results. However, Moskovich’s vision of bloodless circumcision was more successfully accomplished by others later.
By the 1930’s14 many circumcision clamps were available for use in newborns. The introduction of Gomco clamp and the development of bloodless technique by Yellen22 in 1935 and Brodie23 in 1939 have encouraged the practice of routine circumcision. The Gomco clamp is made up of 4 parts; a plate, a stud (Bell), an arm (yoke) and a nut to tighten the clamp. The bell is introduced into the preputial cavity and the prepuce is drawn over it. The plate is then placed over the bell so that the prepuce is sandwiched between them. The arm is fitted into its proper place. When the nut is screwed on tightly, it exerts a crushing force on the junction of the bell and plate. The clamp is left on for five minutes to achieve hemostasis and the prepuce is excised.
In its original design, which has remained unchanged to date, the Gomco clamp involves several cumbersome aspects. As this clamp is the most widely used circumcision instrument, its deficiencies are well known such as: -
- The many component parts of Gomco make assemblage difficult. The loss of a part usually the nut renders the clamp, useless.
- As with any screwing mechanism, the thread must be kept absolutely clean, to avoid difficulties in applying or removing the clamp.
- The Gomco clamp is known to lose its clamping power after prolonged use and age due to warping of the plate.
- The junction of the arm and plate is a wide through. It is possible to assemble the clamp with the arm not properly resting in the trough (with part of it not in the trough). After the nut is applied for pressure, the arm can slip into its proper place depriving the instrument of its clamping and haemostatic effect.
- More importantly the Gomco clamps are made of chrome-plated brass and are prone to wear through at its weakest point in the junction of the bell and plate. The bell has been found to develop grooves and nicks after repeated use with surgical blades. Therefore Gomco clamps should always be examined prior to use to prevent accidental cutting through the bell and possible injury to the glans.
- In rural areas of Nigeria, the Gomco clamp is not readily available and many operators are not familiar with its use.
Many attempts to replace Gomco has led to the development of Preputome, Tribone bell, improved bloodless circumcision clamp, (Tribone + Gomco combined), Kantor clamp and Nutech clamp, Sheldon clamp, all of which are fraught with deficiencies.
Bronsten, Brooklyn mohel, who invented the Nutech clamp also, invented the Mogen clamp. The Mogen clamp is a variation of the Kantor clamp. Instead of crushing the tissue by the attached haemostat, the Mogen shield acts as the clamp. It has the shortcomings of the kantor clamp plus one uniquely its own. With the glans below completely below at of sight, there is a chance that the tip of the glans might be caught in the clamp, however, this is the preferred design of modern Jewish Mohel. Mogen clamp is believed to be swifter, removes less tissue, leaves more mucosa and does not necessarily destroy the frenulum. It is newly reported that it causes less discomfort when used during infant circumcisions than does the Gomco24.
The Sheldon clamp17 resembles the bone forceps and works very similar to the other clamp devices by crushing the foreskin. After the foreskin is cut by the device, a small cutting device is inserted between two clamping mechanisms and the foreskin is removed. Care must be taken by the operator to ensure that the glans does not become trapped in the clamps prior to the excision of the foreskin. There have been attempts to introduce plastic devices viz.:
- Plastibell; marketed by Hollister, Liberty Ville U.S.A.25
- Glansguard, which is a disposable Mogen clamp with in built scalpel described by Melges26.
- Circlamp produced by Gomco24
All the above were unsuccessful attempts to develop instruments superior to the Gomco clamp because none of them incorporates all the benefits of the Gomco without its deficiencies.
The plastibell device was first introduced by Kariher and Smith27 from Rochester, New York USA in 1956. Kariher and Smith initially used the Ross circumcising ring, a metallic device that was used as a template for ischaemic necrosis of redundant foreskin. However Ross rings were found to be not disposable, not adaptable to varying shapes of glans penis and too expensive. Moreover its use was associated with either or primary or secondary haemorhage. Therefore a disposable bell, the plastibell was designed and went into production (Hollister Liberty Ville Ill USA). The plastibell comes in a wide variety of sizes (1.1 through 1.7) for use on infants and young boys25…See plate2.1 and 2.2 for picture a standard infant set. The device is made up of butyrate28. The bell is composed of a small ring attached to a breakable handle, with a groove close to the end of the ring for ligature. The plastibell circumcision technique is so simple that it has been described as an office procedure29…. It is well established that plastibell circumcision is a quick and satisfactory method in the male newborns and older children.
However plastibell is easily deformed after use once the handle is broken off, or if the device is subjected to autoclaving or boiling.
CIRCUMCISION, ETHICS AND MEDICAL PRACTICE
The practice of circumcision has previously been considered harmless to the child; so it can be carried out once the parents or persons lawfully exercising parental responsibility have given appropriate consent30. It is argued that circumcision is necessary for the child’s acceptance into a religion or community, however, the neutrality of the procedure is being increasingly challenged.
It was argued that the practice of male circumcision should be discouraged because it removes an irreplaceable functioning tissue from the genital organ thus violating a person’s legal right to bodily integrity31. More so, the procedure causes unnecessary pain, however, short lived it may be, which is a form of harm and against the first rule of medical profession. Additionally, failure to provide adequate control of pain during the procedure amounts to substandard and unethical practice. However, physicians usually agree to circumcise because of the influence of peer pressure, respect for senior doctor's instruction and community attitudes, at the expense of the welfare of the patient. It is not expected of a doctor to so act against his conscience, if he means no harm.
The ethical duties of doctors with regards to various indications of circumcision for religious or cultural reasons have been outlined by the British medical Association London.34. The doctor is obliged to weigh the potential benefit and harm of the procedure and should explain these explicitly to the patient or person consenting on the patient’s behalf. The British Medical Association strongly recommends that either written consent of both parents or of person(s) with parental responsibility be obtained for circumcision. Legally, parents actually lack the power to consent to non-therapeutic excision of human tissue form children35-37. Nevertheless, consent is necessary before circumcision can be performed. This may be difficult to obtain even in the case of adult males. The foreskin is erogenous tissue38, so adult male may be unwilling to give up documented sexual pleasure39 for the sake of reducing the incidence of HPV (human papilloma virus) infection in others31. In Britain, the general medical council has no policy on the ethics of circumcision. However, the council would take action if a doctor unfamiliar with the procedure or who is inexperienced in it, performs such an operation incompetently. It is advisable for such doctors to consult or refer to a specialist. A list of registered practitioners and professional standards are kept by the initiation society, a professional body for the organization of Jewish circumcision in London. Reference can be made to such. Poorly performed circumcision holds legal implications for the doctor responsible. An action could be brought against him/her on behalf of the child, if circumcision was carried out negligently. Alternatively at age 18, the child could issue such proceedings in his own name. Doctors who may not wish to perform circumcision for reasons of conscience should explain their own moral position but should not impose their own moral viewpoints on the patients who do not share such. In Nigeria, however ,the Nigerian Medical Council is yet to come out with specific ethical and legal guidance for doctors on circumcision of male
NEWBORN CIRCUMCISION AND PAIN
All newborns of viable gestational ages feel pain, because all the anatomic and functional pathways to perceive painful stimuli are present at birth. 6,41 Even when circumcision is done with anaesthesia and analgesia, studies have shown that they do respond physiologically to noxious stimuli.
Dorsal penile nerve block (DPNB) is the most commonly recommended method to relieve pain of circumcision. Proponents considered that the procedure is safe, easy and effective in reducing the stress and pain experienced by the newborn undergoing circumcision6. Experience with DPNB has been extremely limited in Nigeria (No data to support its use).
Oslon and Downey42 prospectively carried out a controlled clinical trial to compare the efficacy of dorsal penile nerve block (DPNB) and eutectic mixture of local anaesthetic (EMLA) for attenuation of neonatal pain during circumcision. Their study involved a total of 20 infants born at a USA Midwestern hospital. Measurements of blood pressure, heart rate, respiratory rate, and oxygen saturation were obtained along with a neonatal infant pain scale (NIPS) grading at five separate intervals (Baseline, restraints, incision, Gomco clamp application and post circumcision) throughout the circumcision procedure. A comparison was done between the two groups regarding response to the noxious stimuli.
They found that infants demonstrate physiological and behavioral response to pain; both of which are observable and measurable. In addition, results showed less response with DPNB as compared to EMLA. The authors concluded that there is a trend towards better pain control with DPNB as compared to EMLA. However the sample size in this study was too small for any reliable extrapolation or generalization to be concluded there from.
Documented specific complications6 with use of DPNB include
- The risk of methaemoglobinaemia after circumcision with DPNB using prilocaine. Prilocaine is an amide local anaesthetic that is not recommended for use in neonates because of it unique metabolism; which results in the production of oxidants and thus an increased risk of methaemoglobinaemia.
- Procedural complications such as haematoma, gangrene of the skin of the glans, inadvertent intravascular injection of lidocaine precipitating systemic effect such as CNS excitation at low dose, seizure, coma and cardiovascular depression at high doses. Inadvertent use of lidocaine preparation containing epinephrine can cause arteriolar constriction with possible vascular injury to the penis leading to gangrene.
- Behavioral And Auditory Change More recently, newborn infant have been shown to develop delayed brainstem auditory-evoked response following the use of lidocaine for maternal epidural anaesthesia for caesarian section. Peak plasma lidocaine concentration following DPNB (Range from 0.1 to 1.6 micogram/ ml) is clearly within the range of 0.7 to 0.8 micogram/ml found following maternal epidural administration.
- DPNB can be as painful as the circumcision procedure43
- DPNB does not block the ventral nerve pain pathways; so it is only partially effective.44 While topical application of EMLA has been found to be effective for pain control of unpremedicated children for minor procedures, however, it has to be applied to the skin 60 to 90 minutes before full efficacy6. Even with this, the cooperation from the child may not improve because in children, one cannot equate behavioral changes with pain. Topical lidocaine cannot be used to provide operative analgesia because it does not penetrate an intact skin. It only penetrates an intact mucous membrane and undersurface of the foreskin and the exposed nerve endings and skin edges, which remain after surgery.45,46 The risk of methaemoglobinaemia makes its use unsuitable for circumcision of children below the age 12 months. Furthermore, it is not a sterile preparation and should not be used on open wounds.
Lander et al47 reported that ring block is more effective than either EMLA or DPNB for control of pain. However, it should be noted that any anaesthetic injection will cause the penis to swell, causing pain and making the surgery more difficult. Moreover, penile injection will require every circumciser to be a physician.
The use of sucrose-flavoured pacifiers as analgesic during circumcision has been demonstrated to be more effective than water by Blares and Hoffmeyers48 . Crying was reduced more than 50% by the procedure. However, the use of such pacifiers may induce osmotic diarrhoea if it is too concentrated or even cause infective diarrhoea if contaminated.
In the newborn, the respiratory, cardiovascular and central nervous systems are functionally immature. This poses increased risk for the use of narcotic anaesthesia and general anaesthesia in them. A newborn anaesthetic mortality rate of 1 in 1000 has prompted a search for safer methods of relieving neonatal pain41. However acetaminophen has been shown to be effective in the pain management of circumcision.
Weitzman 49 and his associates prospectively conducted a double blind placebo control clinical trial of acetaminophen analgesia in 44 healthy full term neonates undergoing circumcision. Two hours before Gomco circumcision, neonates received either acetaminophen 15mg/kg/dose. (0.15ml/kg per dose) or placebo every 6hrs for 24hrs. They were monitored intra-operatively for changes in heart rate, respiratory rate, and crying time. Postoperative pain was assessed at 30,60, 90, 120, 360 minutes and 24 hours using a standardized postoperative comfort scoring system. Feeding behaviour was assessed before and after the circumcision by nursing observation. Their results indicated that neonates in both groups showed significant increase in heart rate, respiratory rate and crying during circumcision with no clinically significant differences between the groups. Postoperative comfort scores showed no significant differences between the groups until the 360minute.postoperative assessment at which time the acetaminophen group had significantly improved scores (P < 0.05). Feeding behaviour deteriorated in breast and bottle fed neonates in both groups and acetaminophen seems to influence this deterioration. They concluded that;
- Newborn circumcision causes severe and persistent pain and
- Acetaminophen was not found to ameliorate either the intra-operative or the immediate postoperative pain of circumcision although it seemed it may provide some benefit after immediate postoperative period.
CIRCUMCISION WITHOUT ANAESTHESIA
Newborns experience pain with many procedures such as phytonadione injection (Vit K) Hepatitis B vaccine injection, venipuncture, bladder tap, calcaneal puncture and other procedures; but not much dust has been raised about medication for pain control for those procedures as there is for circumcision.
Holton50 prospectively compared pain during elective circumcision with and without DPNB and calcaneal puncture.
The study was conducted at a community hospital during a 4-month period to determine whether pain control should be used with calcaneal puncture. He compared two commonly observed newborn behaviours (crying and struggling) during elective circumcision and routine calcaneal puncture and related pain reaction using a modified Gronigen Distress scale. One hundred and ninety-six. Newborns were randomized into 3 groups namely:
(1) Ninety-one male infants who were circumcised with parental consent without DPNB (2) The calcaneal puncture group of 97 newborns consisting of males who were not circumcised and females.
(3) Eight infants circumcised with DPNB with parental consent. Pains during circumcision with and without DPNB were comparable with those of calcaneal puncture.
Interrater reliability was determined by two nurses observing the same newborn at the same point in time for the circumcision and the calcaneal puncture. The Speaman’s P correlation coefficient was used for interrater reliability for crying during the procedure. The Mann-Whitney U test was used to compare the ranks of age, time for procedure and pains of each procedure for independent groups. The Wilcoxon signed rank test was used to compare the mean rank for pain within each group during the procedure. Interrater reliability was achieved for the calcaneal puncture procedure but not for circumcision. The author stated that the lack of inter-rater reliability crying during circumcision was not clear. The Mann-Whitney U test indicated a significant difference in infant time to perform the procedure between newborn in the circumcision group and those in the calcaneal puncture group.(2.1, 2.4 and 2.2) respectively
On the basis of pain scores in this study the author concluded that newborn circumcision is slightly more painful than calcaneal heel puncture. He recommended that the decision for newborn circumcision pain control should be considered within the context of similar pain experienced by newborn with calcaneal heel puncture. He advised that pain control should not be considered for circumcision especially if the pain control procedure causes additional pain or patient risk. Parent should be reassured that the discomfort is short lived and will not significantly affect the newborns, well being.
The above study lacked a control group of children who were subjected to no surgery. This violates the scientific method and hurts children needlessly, because circumcision always causes some pain. Despite the need for pain control in infants, most doctors do not use any form of anaesthesia for newborn circumcision..
A study by Stang et al in 199851 found that only 25 percent of obstetricians, 56% of family practitioners, and 71% of paediatricians; who are circumcisers muse anaestesia. In the same yea, Howard et al52 reported that 26 percent of newborn circumcision training program do not be surprising to find that most doctors in Nigeria are not trained to use anaestesia for newborn circumcision.
Since all methods only reduce but do not eliminate pain and the practice of routine circumcision still remains with us, many doctors in this country may have to keep on circumcising newborns without anaesthesia till they acquire the skill through continuous medical education.
CIRCUMCISION IN NIGERIA
Male circumcision is often practiced for children in Nigeria. Circumcision in the newborn is part of our culture and is performed routinely within the first week of life in most parts of the country53.
In the Western part of Nigeria today, circumcision is a must for males and a basis for acceptance of females into family circles. In some parts of the country uncircumcised children are sometimes regarded as “unholy” and are looked down upon as socially inferior53 The result of this is that, children are mostly circumcised before the naming ceremony which usually comes up on the eighth day of life. This compares with the practice amongst the Jews12 and contrasts with what obtains in Europe and North
America,13 where circumcision is indicated by such complications as phimosis, paraphimosis or balanitis xerotica obliterans54 This ritualistic practice is thought to be responsible for the low penile cancer rate in Nigerians as in Jews.55
In our rural and semi urban population, this surgical procedure is performed by traditional birth attendants, preferably one with children who has a good track record. It is done under non-sterile conditions usually with any sharp object, (e.g. broken bottles, razor blades, stones, knives etc) 56. Infection particularly of the clostridium tetani is common and many neonates die from overwhelming tetanus56,57. In urban settings, modern midwives and nurses, and some doctors perform routine circumcision using razor blades, sterilized with methylated spirit or with sterile surgical blades. Amongst this group of patients infection is less frequent but penile injury is common.56
Generally, there is dearth of literature on male circumcision in Nigeria. Few local studies from different parts of the country are reviews of referred cases managed for postcircumcision complications by urologists and paediatric surgeons in few Teaching
Aina58 in Lagos, reviewed nineteen cases of post traditional circumcision complications referred to Lagos University Teaching Hospital between 1973 and 1977. The complications were twelve cases of urethral fistulae and 7 cases of poor cosmetic results. He reported that; all but one of the 19 complications was presumed to have been circumcised by the open method because Gomco and plastibell kits were not readily available and there was no way of obtaining accurate information concerning exact operative techniques. He however concluded by recommending that proper use of plastibell device when available will reduce incidence of complications.
Aina’s study was not only unspecific about techniques of circumcision, it also did not reference any study about good outcomes from the use of plastibell, hence, his extrapolated recommendation for the use of plastibell which was not available then in the country is not justified.
A study by Badejo53 in Ile-Ife retrospectively reviewed 37 cases of circumcision complications referred to the Teaching Hospital for management over a five year period. (1976 to 1980) The patients studied were aged 5 days to 18 months, with 25 males and 12 females.
All of them had packed cell volume (PCV), Haemoglobin (Hb), bleeding and clotting time determined. Swabs were taken in all cases of infection while all those admitted for elective surgery had chest x-rays and urinalysis done.
Their results: twenty patients (16 boys and 4 girls) had profuse bleeding, 5 patients had severe infections, 4 patients had iatrogenic hypospadias and 1 patient presented with inadequate circumcision. Other complications were: epidermoid inclusion cyst in 5 patients (4 females, 1 male) and 2 cases of labial fusion.
The author found that the bleeding and clotting time of those patients that bled profusely were much higher than what was regarded as normal by a referenced author, Pichokta, in a European study. The referenced study was quoted as indicating that children with bleeding time less than 2 minutes and clotting time below 3½ minutes hardly bled at all at surgery. In conclusion therefore, Badejo, emphasized the need for pre-operative determination of the bleeding and clotting time which; to his knowledge had not been suggested before. Furthermore, he devised a quick method of sleeve circumcision resection technique, which is suitable for controlling haemorhage in our environment.
Nevertheless, Eni3 a youth corps doctor carried out a prospective study on infant circumcision in a rural clinic in Cirie, a town in Song local government area of Adamawa State, in the north eastern part of Nigeria. One hundred and twenty male infants aged 2 weeks to 6 years were circumcised with plastibell device between January 1984 and February 1985. No pre-operative anaesthesia was given to infants less than 2 years of age. However, 2.5% (plain) xylocaine or 0.25% bupivacaine was used for penile block in those infants that were 2 years and above. Syrup paracetamol was administered as post-operative analgesia to all.
He reported 3 complications made up of 2 postoperative infections and 1 postoperative hemorrhage, all of which were treated in the clinic and covered with procaine penicillin injection and ampicillin syrup.
He claimed that;
- There was no difficulty in voiding as compared to other methods.
- The cosmetic results were good even for those who were re-operated to correct complications.
- The surgical procedure was short and simpler than other procedures.
He recommended the use of plastibell for circumcision because of its cheapness and simplicity of use.
The above study did not specifically compare plastibell with other techniques in relation to complications, cosmetic outcome and speed of procedure to justify his claims. Moreover, the author did not state the criteria upon which he based his assessment of cosmetic outcome. The article would have been more educative if the author had stated the mean procedure time and the cost of plastibell kit as at then. However his study threw a challenge to residents like the present researcher.
A more recent study by Bode and Kene-Ewulu1 in Lagos threw more light on circumcision complications, techniques and personnel involved. Ninety cases of post circumcision complications referred to Lagos University Teaching Hospital between January 1995 and 1996 December were reviewed.
During that period of study, the genitalia of 90 male children aged 10 days and 12 years attending the clinic were examined for any post circumcision complications. Details of where the procedures were performed, duration of complaints, personnel involved, method employed and types of complications were recorded. The age at circumcision, definitive management and outcome were noted. Eighty-four cases presented primarily, while 6 were incidental findings in these children who attended clinic for other surgical problems. There were 25 cases of urethral fistulae, 22 skin bridges, 19 cases of redundant skin, 14 cases of wound infections, 8 episodes of post circumcision bleeding, a glanular amputation and one proven post circumcision meatal stenosis. Sixty-three percent of all complications follow circumcision performed by doctors while 30% resulted from circumcision by nurses and only 1 complication by a native doctor. Sixty-four percent of complications were caused by the use of open method and the remaining 36% resulted from the use of plastibell.
A later study by Osegbe 56 in Lagos retrospectively evaluated 34 patients with genital injuries managed in the urology unit of Lagos University Teaching ospital over a 5- year period (Jan 1994 to June 1999). Thirty-four patients with genital injuries aged between 2 weeks and 59 years who had good records were reviewed. Eleven patients were below 9 years while 15 were between 20 and 49 years. There were only 2 female patients. They found that circumcision was a major cause of penile injury accounting for 26.5% of the patients.
This contrasts with 5.4% reported from London. Midwives accounted for 44%of penile injury. Surprisingly, more was caused by traditional birth attendants. Doctors accounted for a sizeable number; 56% of circumcision related penile trauma
An earlier study by Ahmed et al59 in ABUTH in Zaria lends credence to the above but with smaller sample size. Forty-eight male children aged 3 days to 7 years were studied between January 1981 and December 1995. They were retrospective studies of case notes, operation and casualty admission registers and discharge summaries. Haematocrit, urea and electrolyte were tested in all patients. Bleeding and clotting times and platelet counts were done in all cases who presented with haemorrhage. Their results were 25 cases of haemorrhage, 10 cases of infections, one case of amputation of penis and 3 cases of meatal stenosis and 5 cases of urethro-cutaneous fistula. Sixty-four percent of those with haemorrhage were neonates.
They observed that most complications were seen between 1991 and 1995 when surgical fees had been introduced and the number of boys circumcised in the hospital decreased.
With the exception of Bode and Kene-Ewulu’s study in Lagos1 and that carried out by Eni in Adamawa State Nigeria3, others did not relate the complications with specific device or technique. Most of them were retrospective studies of referred cases fraught with methodological flaws. Hence, their conclusions cannot be extrapolated to the general population.
Nigerian law allows nurses to perform simple surgical procedures at the request of or under the supervision of a medical doctor.40 A strict interpretation of this would include circumcision. The law, however, excludes traditional medicine men from this restriction and hence allows unbridled right for traditional medicine men to perform circumcision, which in Nigeria is done for cultural reasons and tribal rites. Nurses seem a ready and cheaper alternative in achieving this end in primary health centre settings.
Bode1 recommended that such nurses should be identified for training as a way of ensuring safe circumcision practices devoid of complications.
These studies disproved the assumption that circumcision being a simple procedure is safe in the hands of any doctor. Bode1 emphasised the need for continuous education of doctors about circumcision complications and correct ways of performing it.
COMPLICATIONS OF CIRCUMCISION
In spite of the so many methods designed over the open dissection technique in order to remove or reduce complications, no method or device is problem free.1 More often than not, however, complications arise as a result of operator’s inexperience rather than the method employed. The true incidence of postoperative complications after circumcision is unknown60
Some authors have reported a complication rate as low as 0.06 percent while at the other extreme, rates of up to 55 percent have been reported.20 In a series studied in Zaria, Nigeria in 1998, complication rate of 0.32 percent was found.59 This reflects the differing and varying diagnostic criteria employed. A realistic figure has been set at 2 - 10%. 20 Its low incidence in some series is probably due to initial treatment offered at centres where procedure was performed. It is however, pertinent to note that the risks of newborn circumcision are grossly under reported and ignored.
More often, a poor surgical result is not recognized until years after the event. Moreover, the adverse long term consequences of infant circumcision on the sexual health of the circumcised, would-be men in the later years, cannot be ignored by parents, physicians and law makers.34
MALE NEWBORN CIRCUMCISIONS IN OGBOMOSO: A COMPARATIVE STUDY OF THE USE OF DISPOSABLE PLASTIC DEVICE WITH THE STANDARD: PLASTIBELL