ANÁLISIS DEL MARCO CONCEPTUAL PARA LA PREPARACIÓN Y PRESENTACIÓN DE
2. ANÁLISIS DEL MARCO CONCEPTUAL PARA LA PREPARACIÓN Y PRESENTACIÓN DE ESTADOS FINANCIEROS Y LAS NIIF RELACIONADAS
2.4 NIC 18 Ingresos Ordinarios
METHODOLOGY
A series of sixty consecutive newborn males were recruited from consenting parents at the Lagos University Teaching Hospital, LUTH. Institutional Ethical Committee approval was obtained from LUTH authorities (Appendix 1). The patients were divided into two groups consisting of 30 Subjects (S Group) and 30 Controls (C Group). All the 60 newborn males underwent circumcision using the Plastibell device. In the Controls, the Plastibell ring was allowed to fall off by itself as recommended by the manufacturers while in the subjects (S) group, the device was removed on follow-up at 24 hours by the investigator. The circumcision procedure was offered to all patients free of charge but the parents procured the post operative analgesics from the Hospital Pharmacy Department at their own cost.
Pain in the post-circumcision period was assessed using the Face, Leg, Activity, Cry, Consolability test ( FLACC)54. This uses 5 different parameters to determine the level of pain experienced by a child recovering from anaesthesia. Each parameter is graded from 0 to 2 so that the minimum score is 0 and the maximum is 10. The scale is reproduced below ( Table 1).
THE FLACC SCALE:
Face No particular expression or smile. Occasional grimace or frown, Frequent to constant quiv- withdrawn, disinterested. ering chin, clenched jaw.
Legs Normal position or relaxed. Uneasy, restless, tense. Kicking or legs drawn up.
Activity Lying quietly, normal position, Squirming, shifting back and Arched, rigid or jerking.
moves easily. forth, tense.
Cry No cry ( awake or asleep ) Moans or whimpers, occasio- Crying steadily, screams nal complaint or sobs, frequent complai-
nts
Consolability. Content, relaxed. Reassured by occasional tou- Difficult to console or
ching, hugging or being talked comfort.
to, distractible.
Table 1
This scale assesses the level of post operative pain in young children recovering from anaesthesia. It is easy enough for parents to understand and to score.
Parameter 00 111 222
Sample Size:
The sample size was determined by a sample size formula for determining 2 independent means36:
n= 1
X
2X(Zα+Zß)X(1-P) 1-f (P0 – P1)2 Where n = Sample size expected.f = Attrition rate fixed at 10% = 0.1
zα = The possibility of making a type 1 error = 0.5 (5%) = 1.96
zß = The standard normal deviate corresponds to the probability of ß ( i.e . the probability of making a type 11 error = 20% i. e. power = 80%) 0.84.
Po = Prevalence rate in the control group.
P1 = Known prevalence rate.
P = Mean of Po and P1.
A previous study in the United Kingdom 36 , used because no local or national figures are available, reported a Sample Size Index ( SSI) rate of 70% in the study group i.e. P1= 70 % ( 0.71). Expected prevalence in the control group ( Po) = 100% (1.0)
Therefore;
n = 1 x 2x(1.90+ 0.84)2 x 0.85 x 0.15 1-0.1 (0.3)2
1.11 x 15.68 x 0.1275 0.09
= 1.11 x 22.21
= 24.65 ≈ 25.
Consequently, 25 patients would have been sufficient for this study and another 25 in the control group but a round figure of 30 was selected so that the first 5 could be especially closely monitored.
Patients, Materials and Method
The patients recruited into this study were 60 consecutive healthy male newborns with normal external genitalia whose parents requested for circumcision. Those who met the following inclusion criteria were selected:
Inclusion Criteria
1) Full-term neonates.
2) Circumcision requested by parents.
3) Parents consent to the use of Plastibell.
4) Parents agreement to participate in this study.
5) Patients who live within an hour’s traveling distance of the hospital.
6) Parents of patients who had mobile telephones55,56.
Exclusion Criteria
1) Low-birth weight boys less than 2.5kg.
2) Babies with nappy rash or pemphigus.
3) Those with a family history of bleeding diathesis, or haemophilia.
4) Pre-term babies.
5) Babies with genito-urinary anomalies such as Hypospadias, Epispadias, huge bilateral hydrocoele or ambiguous genitalia.
6) Buried penis .
Grouping
The patients once recruited were randomly selected as Subjects (S) or Controls (C) by closed balloting.
Informed Consent
The parents were fully briefed on the procedure. A written informed consent was obtained from each parent and this was fully explained in local languages to illiterate parents in front of witnesses. Each mother was given a dedicated telephone number through which to call the investigator in case of any complications.
Pre-Operative Protocol
All patients for circumcision had a Packed Cell Volume (PCV) estimation preoperatively.
They were required to arrive in the hospital by 8 a.m on the operation day after having fasted for two hours prior to the procedure. All babies were given intramuscular vitamin K 1 mg stat a day before circumcision to prevent the risk of having to deal with bleeding occurring from haemorrhagic disease of the newborn. This was of importance especially among the Subjects whose Plastibell rings would be removed 48 hours after being given vitamin K.
Surgical Protocol
Each patient was taken into the operating room well covered to prevent hypothermia. He was then restrained in the Lithotomy position by an assistant and the perineum swabbed with Savlon lotion (1 in 60 concentration). Proper draping was ensured and a penile ring block using 0.25% plain Xylocaine given circumferentially at the root of the penis55,57. All the circumcisions were performed by the investigator under aseptic conditions58. With two pairs of artery forceps, the prepuce was held at 3 o’clock and 9 o’clock positions (Fig.2)
Fig 2: Artery Forceps at 3 o’clock and 9 o’clock positions
A third pair of artery forceps was then gently used to free the adherent prepuce from the glans. A 1 cm dorsal slit (Fig.3) was made through a crushed portion and the prepuce was retracted to reveal the smegma in that recess. The smegma was cleaned off with a piece of sterile gauze until a dry bed was seen. An appropriate size of the Plastibell ring was then inserted into the preputial space (Fig 4).
Fig 3: The Dorsal Slit
The device was then secured in place by applying a third pair of artery forceps at right angles to the first two pairs holding the prepuce (Fig.4)
It was retained in this position by means of a clamp while a ligature was tightly applied to the skin over the groove in the ring, thus crushing the prepuce against the non-yielding plastic ring.
The skin distal to the ring was trimmed off and the plastic handle broken off to complete the procedure (Fig. 5).
Fig 4: 3rd pair of artery forceps securing the Plastibell in the Preputial Space
Fig 5: The retained Plastibell Ring following excision the Prepuce.
Post Operative Care
A petrolatum jelly gauze dressing (Sofratulle) was applied and the patient observed for a minimum of one hour before discharge. Oral Paracetamol, 10-15mg per kg body weight every 6-8 hours and Promethazine 2.5mg every 12 hours were given as analgesia and tranquillizer respectively54,55,57. Parents of the Subjects group were instructed to bring the patients 24 hours post circumcision for removal of the Plastibell ring. All parents were instructed to report sooner if a complication was suspected to have arisen. Written instructions with 24-hour help-line telephone numbers were given to each parent (Appendix II). The parents of the Control Group were instructed to visit the investigator on alternate days until the plastic ring fell off. Those in the Subject group who had their Plastibell rings removed after 24 hours were taken into a dressing room so their mothers were present. Their genitals were then exposed after removing the Petrolatum dressing and the phallus examined for any sign of bleeding. A sterile dressing pack was opened and a pair of sterile stitch scissors used to remove the string while donning a pair of sterile gloves. In the first 5 cases, the stitch removal was difficult with the traditional stitch scissors. The removal of the string became easier with the use of a small, sharp, stitch scissors, while a pair of artery forceps was used to hold the knot for stability.
Haemorrhage
All babies were observed for one hour, for any bleeding, before being discharged home. All mothers were specifically instructed not to completely cover the babies’ genitals in diapers once at home so that any bleeding occurring would be immediately obvious.
Infection
A second generation cephalosporin such as Ceftazidime, was prescribed for a clinically
gram negative organisms, its ready availability and the convenient administration which should encourage compliance.
Pain
The persistence of post-operative pain was treated with oral paracetamol and promethazine to keep the babies calm. There were no babies who were averse to taking these oral medications.
Proximal Migration
This particular problem was prevented from occurring by choosing an appropriately-sized Plastibell and also by not unduly placing traction on the penile skin while applying the string to the plastic ring. The effect was to preserve the length of penile skin that would not be compromised by retracting skin when oedema subsides. Gross penile swelling did not result from circumcision, such that the organ appeared endangered in any form.
The incidence of common complications such as bleeding and infection were recorded on the proforma while the day of complete wound healing was determined with the parents in attendance and also recorded for all babies. Wound infection was categorized based on the classification used by MacLennan58 viz:
Grade 1: Undue hypereamia of the wound.
Grade 2: Serosanguinous exudation from the wound.
Grade 3: Purulent discharge.
Grade 4: Complete wound breakdown.
In this study, the appearance of any of these changes was described as an infection, even though any infection was generally expected to be mild and no more than a cellulitis.
Fall-off Day of Plastibell
The fall-off day of the Plastibell ring was determined by the complete separation of the device from the penile shaft such that it fell off by itself. Patients in the Control Group were reviewed every 2 days until this happened. They were requested to visit the clinic on alternate days to monitor their children’s progress until the device fell off. The parents were also instructed to call the investigator if the ring fell off on a day in which they were not scheduled to be at the hospital. They were also advised that any ring which remained in place after 10 days would be surgically removed. This group included even such devices that were partially attached to the penis by the 10th day.
FOLLOW-UP
All patients in the two groups were seen on the first post operative day. Following the removal of the Plastibell ring in the Subject group, patients were seen every other day until the wound was adjudged to be fully healed. Among the Controls, follow-up was conducted every other day also in agreement with the pattern already utilized for the Subjects and recommended by Duncan et al 59 which they found to be satisfactory. Those patients who did not come back to the hospital on specific dates were contacted by telephone and any developments were noted on the proforma as was done for those who showed up. Full wound healing was determined by the presence of any two of three factors enumerated by the investigator and these were noted as follows;
1) Dry muco-cutaneous edge 2) Absence of any discharge
3) Difficult separation of muco-cutaneous junction.