3. Formulaci´ on del problema
3.4. Modelaci´on del dominio
3.4.1. Acciones a utilizar
lix
lx Then substituting
Since two samples are needed for the 2 devices PB and DPD.
N = 2 n
= 2 138 = 276
However, in order to give room for possible default and missing cases, the sample size has been extrapolated such that the total sample size N = 320.
2
) 2
1 (
z P
n P
2 2
) 05 . 0 (
) 96 . 1 )(
1 . 0 1 ( 1 .
0
0025 . 0
) 96 . 1 )(
9 . 0 ( 1 .
0 2
138
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PATIENT RECRUITMENT
The patients studied were Nigerian male newborns: aged between 8 days and 60 days inclusive. They were all healthy, with intact prepuce and no defect of the external genitalia with no manifest bleeding problem or family history of bleeding disorder and whose mothers have no preference for any particular method of circumcision.
Before enrolment, the author explained the proposed project and the follow-up plan, to the appropriate authorities of the respective health facilities and obtained necessary permissions. Male newborns of volunteer mothers/guardians were preliminarily examined to rule out exclusion criteria.
Exclusion Criteria
1 Male newborns younger than 8 days or older than 60 days.
2 Those within the age range (8 ≤ 60 days) :
(i) Who are not well (with conjunctiva parlor, jaundice, fever, cardio-respiratory problems)
(ii) Who are well with family history of bleeding.
(iii) Whose mothers/guardians brought for re-circumcision.
(iv) Those with defect of the external genitalia.
(v) Those whose mothers had preference for a particular technique.
Male newborns were enrolled once the consent form (Appendix A) has been duly signed by the mothers or persons with parental responsibility. There after personal data, socio-demographic characteristics of the parents/guardians and findings on physical examination of the newborns were documented in the Proforma. (Appendix B).
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PATIENTS ALLOCATION TO METHOD (DEVICE) OF CIRCUMCISION Initially a sample frame was obtained by modulo randomization procedure using a computer - resident general linear model program. A set of three hundred and twenty numbers, half of which were randomly assigned to each of the two methods (PB and DPD)such that 160 numbers were supplied on command to go for PB while the missing numbers were for the experimental DPD group.
Male newborns were allocated at random by opening the next in a series of consecutively numbered sealed envelopes to either plastibell method or disposable plastic device method for circumcision. The number is recorded on the proforma (section D). Each of the numbers was cross-checked against the sample frame to identify the device before the commencement of the surgery. The following are the list of instruments employed in the circumcision procedure
INSTRUMENTS
1. (I) Weighing scale (II) Thermometer (III) Stethoscope (IV) Stop clock (V) Non-heparinized capillary tubing (VI) Lancets (VII) Sterile cotton wool (VIII) Sterile gauze packs (IX) Blotting paper or filter paper (X Sterile disposable plastic device (DPD) (XI) Plastibell kit
2. Circumcision set –
(I) sterile bowl (II) 3 pairs of mosquito forceps (straight 1 pair, curved 2 pairs) (III) 1 pair of small scissors (IV) sterile towel (V) A pair of gloves
The Disposable Plastic Device
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Dr. Sola Freeman, a private medical practitioner in Ilesa Osun State Nigeria originally designed this device. For reasons of cost and non-availability, he had fashioned out small cylinders from plastic syringes and made a groove in the middle of the device for ligature. The plastic syringes are made of polypropylene102 which is stiffer and more heat resistant than butyrate.28
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PLATE 1.1 From left: Plastibell and cotton ligature. Disposable plastic syringe with Nylon suture wound round it. Note the handle. Disposable plastic syringe- note the groove in the mid point of the cylinder.
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PLATE 1.2 From left: gallipot containing 5cc syringe and disposable plastic device. Pairs of needle holder forceps, scissors straight and curved forceps, cotton balls, stop clock, plastibell kits, pieces of gauze, filter paper, pairs of gloves all lying on sterile towel.
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PLATE 2.1 Plasibell before use. Plastibell after use when the handle has been broken off. Plastibell after autoclaving, or boiling ia an attempt to re-use it. Note that it is grossly deformed, so it is not re-usable. Disposable plastic device before and after use- before and after boiling or autoclaving. Note that NPD is not deformed.
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PLATE 2.2 Plastibell after use- after autoclaving. Disposable plastic device with intact configuration after boiling.
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The researcher, having obtained the consent of the originator, proceeded to improve the design with specific measurements where possible. He employed the service of a welding artist who utilized the instrument, flexsaw to cut off the wing and nozzle at the ends of the syringes. (2cc, 5cc and 10 cc corresponding to small, medium and large sizes). The height of the cylinder was made to be about three-quarter (¾) of the diameter of the barrel.(the ratio was made similar to that of plastibell) Thus 5cc cylinder with a diameter of 1.3cm
1.4cm was cut at a length of 9 – 10 mm 1cm for uniformity.
The grooves were imprinted uniformly and circumferentially with the use of LATHE machine at a distance of 0.5 cc on 5cc syringes. The alternate markings are then deepened with lathe machine so carefully that the depth does not exceed half that of the thickness of the wall of the plastic cylinders, to ensure good strength. (When no shearing/
twisting force breaks the wall of the cylinder through the deepened groove(s) or makes it pliable). The barrels were then cut at alternate markings with the flex saw. The edges of the cylinder are then thoroughly smoothened with nail file. The device was then soaked in povidone-iodine10% solution for 5 to10 minutes to kill the spores of fungi.103 Before use, they were sterilized by boiling for 30 minutes.
Personnel
Before the commencement of the study, a period of training was organized for some students and the members of staff of the two maternity centres who volunteered to assist in the research. Emphasis was laid on:
1. how to position and restrain the child during circumcision,
2. the correct use of instruments such as thermometers, weighing scale, stop clocks and the entry of data into the proforma and register where necessary.
3. the recognition of complications . 4 assessment of parental satisfaction, 5 assessment of cosmetic outcome.
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THE PROCEDURE OF CIRCUMCISION.
All eligible male newborns were circumcised without anesthesia by the researcher using the standard technique recommended for the plastibell (Hollister Libertyville ILL.
USA).
The male newborn was placed supine on a flat table on a clean towel or linen. An assistant restrained the child’s hands together with the flexed and abducted hips in a near lithotomy position (Plates 3.1 – 3.4). The perineum was swabbed with 1-% chlorhexidine and cetrimide solution .The size of the device was pre-determined by using 2(0) non-absorbable suture (silk or nylon) which was looped round the greatest diameter of the intact prepuce (i.e at the widest diameter of the glans just before the coronal sulcus) to estimate the circumference. The loop was clamped or knotted and carefully removed and the size tried against some moulds of either the device or plastibell as deemed necessary.
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PLATE 3.1 PLATE 3.2
Mothers with their male newborns, Intact prepuce
the author and research assistants in a group photograph before circumcision in one of the centres.
PLATE 3.3 PLATE 3.4
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Intact prepuce magnified. Note the physiological The author and an assistant
Phimotic ring of the foreskin with the male newborn being
commencement of circumcision.
After the perineum had been swabbed, the foreskin was pinched at the level of the coronal sulcus dorsally. The stop clock was then started as soon as the procedure began.
The prepuce was grasped with three mosquito forceps, one at the frenulum (for proper orientation) and 2 dorsally, all equidistant from one another (forming an equilateral triangle). A curved mosquito forceps was carefully inserted into the preputial opening. Care was taken to keep the tip of the forceps tenting on the skin at all times to keep it out of the urethra. The preputial adhesion was carefully and gently separated from the glanular surface, with curved mosquito forceps being carefully held open to avoid clamping the glans, nor cause damage to the preputial fornix or the corona. A pair of straight forceps with the lower blade abutting the inner preputial membrane was carefully pushed up to about 3 –4 mm distance short of the initial coronal marking. It was then locked in place (Plate 4.1) to exanguinate the foreskin for 10 seconds before a dorsal slit (Plate 4.2) was made. Thereafter, the prepuce was folded over (Plate 4.3) and carefully teased off the glans using a wet cotton swab (rather than a gauze to avoid bruising the glanular surface) till the coronal sulcus was almost circumferentially exposed. The frenular area was excluded to avoid damage to the frenular artery. All the pearls of smegma were carefully removed. The glans was re- swabbed and an appropriate sized device ( PB or DPD) was inserted to cap the glans (plate 4.4). The prepuce was then pulled over it to a point where the initial coronal marking came to lie exactly at the midpoint of the device (area of the groove). Care was taken not to overstretch or pull the prepuce too much over the device to avoid removing too much skin or pulling the urethra up and injuring it.
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PLATE 4.1 PLATE 4.2
Making of dorsal slit. Reflecting the inner preputial
membrane
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PLATE 4.3 PLATE 4.4
Clearing the smegma Inserting the DPD barrel (cylinder)
over the glans
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To avoid the slippage of the device, the foreskin was clamped across the distal end of the device in such a way that the marking on the prepuce falls in the device groove. The suture was firmly tied to achieve haemostasis at the distal end of the incision (Plates 5.1 to 5.4). The foreskin was then trimmed round with scissors. The handle was then broken off in the case of plastibell. The assistant stopped the clock and the time was recorded in minutes. No dressing was applied in all cases104 (Plates 6.1 to 6.2)
Post-Operative Care
Complication(s) such as bleeding, slipping of the ring after ligature and necessary treatment or intervention was recorded. All circumcised male newborns were observed for a period of 30 minutes after the procedure.
Before discharge, each mother or guardian was given an instruction leaflet on the care of the circumcision wound.
It was impressed on her; to
1. bath the perineum with tepid warm saline solution,
2. ensure that the diaper is not tight if it must be tied at all until the wound heals, 3. let the necrotic foreskin fall off on its own with the plastic ring, usually within one
week of circumcision, leaving a clean excision, 4. note the exact date the ring dropped off,
5. notify the doctor immediately if she notices:
a. any swelling,
b. active bleeding (usually appearing as a spot of red blood larger than a one naira (N) coin on the diaper),
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PLATE 5.1 PLATE 5.2
DPD cylinder already inserted and the prepuce Ligature already tied.
clamp across it. Ligature yet to be tied.
PLATE 5.3 PLATE 5.4
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Plasibell already inserted and the prepuce clamped Plastibell in place, the excess across it. Note: the ligature is yet to be tied across the plastibell. foreskin already trimmed off but the
handle yet to be broken off. Ligature already tied.
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PLATE 6.1 PLATE 6.2
DPD in place with ligature in place and the Virtually similar appearance
Excess foreskin already trimmed off. when PB is in place. The foreskin trimmed off and the handle already removed.
PLATE 6.3 PLATE 6.4
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Circumcised penile appearance after DPD. Note Normal circumcised appearance The device on the lap of the newborn with necrosed after device circumcision.
skin tagged and ligature around it.
lxxix c. foul odour or pus,
d. the ring has slipped onto the shaft of the penis,
6 that healing process usually takes about 7- 10 days during which time the tip of the penis will be bright red (Plates 6.3 – 6.4 ) initially before it fades after which the penis will regain normal skin colour from the tip to base.
7 return to clinic for follow-up on the post-operative day 7 for assessment.
FOLLOW-UP.
At the seventh (7th) post-operative day, patients and their mothers/guardians were seen by the nurse midwives who;
A. asked specifically;
1. the day the ring dropped off,
2. history of fever or difficulty in voiding.
B. checked for observable complication(s);
a. objective tenderness as the newborn was undressed for physical examination, b. swelling or oedema,
c. infection, presence of pus or erythema,
d. retention of the ring. (Failure of the ring to slough off within 7 days).
e. skin bridge, f. redundant skin,
g. glanular injury among others.
The assistant then asked
lxxx
(1) for the parent’s impression about the use of the device(parental satisfaction) whether he/she was.
- not satisfied,
- just satisfied,
- very satisfied that she could recommend its use in the future.
(2) the researcher to review those with complications to - confirm the diagnosis,
- institute prompt and appropriate treatment with short appointment for further follow-up.
All the information was recorded in the questionnaire designed for the purpose Babies with complications were selectively followed up at short intervals as deemed necessary.