Presented at the annual meeting of the Association of Surgeons of The Netherlands on 18–19 May 2000.
Objective To compare the results using a new disposable clamp (the Taraklamp Circumcision Device®, TCD, Taramedic Europe BV, Bilthoven, The Netherlands), used since 1998 in one clinic, and the conventional dissection technique (CDT) in another clinic, for religious circumcision in infants.
Subjects and methods The TCD and CDT were compared prospectively; the duration of the procedure, complications and postoperative pain were recorded. The cosmetic result and the degree to which the parents were satisfied were evaluated after 6 weeks. After obtaining informed consent, 275 boys were included in the study (median age 3 years).
Results The median operative duration was 8 min less for the TCD (15 vs 7 min; P < 0.001). There was no difference in complication rate (bleeding in one vs two; infection in two vs three) and postoperative pain was comparable in both groups. The cosmetic results were better for the TCD group (P < 0.001). The parents' satisfaction score for the procedure was equal in the groups, at 8, on a scale of 1 (very bad) to 10 (extremely good).
Conclusion A religious circumcision outside the hospital with the TCD is quicker and leads to a better cosmetic result than with the CDT, without increasing morbidity.
Islamic circumcision was introduced on a large scale in the Netherlands during the 1970s, when families of male labourers originating from Turkey and Morocco were allowed to enter and settle. Although circumcision is not mentioned in any form in the Koran, Muslim society considers it to be an obligation, as it is a tradition of Prophet Mohammed (‘Sunnah’) . This ritual is mainly an initiation rite into the Muslim (religious) community and can be seen as a social marking without which the male cannot belong to the group .
Traditionally the family and friends gather to witness the operation and to celebrate afterwards, which is not possible in Dutch hospitals, where most of the 10 000 ritual circumcisions are carried out annually . A few years ago, health insurance companies announced that they would stop reimbursement for hospital admission, which costs ≈ 400 Euro. Consequently, two outpatient clinics (not in a hospital) for circumcisions under local anaesthesia were initiated in the cities of Rotterdam and Utrecht. These clinics were well appreciated by the parents and the complication rate was in accordance with published values . Furthermore, the cost was 70% less than with clinical circumcisions under general anaesthesia.
To improve the results and to reduce the operating time, a new disposable clamp (Taraklamp Circumcision Device®, TCD, Taramedic Europe BV, Bilthoven, The Netherlands, Fig. 1) has been used in Utrecht since 1998. The initial results were promising and a prospective comparison between the two methods was started .
Subjects and methods
The clinics in Rotterdam and Utrecht are similar in design, and religious circumcision in a hospital is no longer possible in either city. Only boys aged >2 years and referred by a GP are circumcised. In Utrecht the parents were offered a circumcision with the TCD, whereas in Rotterdam only the conventional dissection technique (CDT) was carried out. In both clinics residents and GPs, supervised by a surgeon, carried out the circumcisions. The ethics committee of the University Medical Centre of Utrecht approved this study.
Midazolam (0.4 mg/kg, 5 mg) was administered rectally 15 min before the operation. Local anaesthesia was obtained by subcutaneous injection with a small-diameter needle (25 G) of 0.2 mL/kg (<5 mL) lidocaine 1% at the base of the penis. After disinfection, the physiological adhesions between the glans penis and the inner mucosal layer of the foreskin were freed with a probe.
For the CDT, the foreskin is pulled up and transected distally from a straight clamp placed just above the glans penis. Next, the skin side of the redundant prepuce is shortened with scissors to a level just proximal to the corona. Then the inner mucosal layer is trimmed to ≈ 3 mm above the corona. After haemostasis is obtained by unipolar electrocautery (maximum power 25 W), the skin edges are approximated using a running absorbable suture (polyglactin, rapid Vicryl 4/0, Johnson & Johnson, Amersfoort, The Netherlands).
For the TCD technique, the level of circumcision is marked preoperatively on the skin side of the prepuce with a surgical pen, just proximal to the corona. By selecting one circular hole of the measuring card, with a diameter just large enough to encircle the glans penis at the level of the corona, the correct clamp is chosen from eight sizes with diameters of 12.5–32 mm. After stretching with a straight clamp, the foreskin is pulled over the rim of the inner tube and positioned inside the outer ring to the level previously marked (Fig. 2). If the orifice is too narrow, a dorsal slit is made. Just before the clamp is locked by pushing the two levers inwards, the frenulum is pulled up through the clamp with a suture, thereby stretching the urethra to prevent postoperative urinary retention and pain during voiding. Then the foreskin is cut circumferentially 1–2 mm distal to the outer ring, with the inner tube protecting the glans (Fig. 3). The clamp is left in place and the boy is able to urinate through the open end. After 4 days the connection between the inner tube and the outer casing is cut and removed. The inner tube is left to fall off spontaneously in the following days.
The parents were instructed both orally and by an information leaflet to shower or bathe the wound daily and to apply fusidic-acid cream twice a day to the wound edge. In case of pain the parents were advised to administer acetaminophen orally or rectally as suppositories. Enough medication for the first 5 days was given to the parents. Both the duration of the procedure, e.g. the time elapsed after injection of local anaesthesia until wound care, and operative or postoperative complications, were recorded. Bleeding was defined as the necessity for re-exploration and suturing for haemostasis. Infection was defined as erythema with pus only, when antibiotics were prescribed. On the fourth day after operation, the parents in Utrecht were interviewed during removal of the TCD, whereas the parents in Rotterdam were questioned by telephone. The postoperative pain and pain during voiding was measured by proxy, by scoring these items on a scale of 1–5 (Dutch version Verbal Rating Scale: 1 = no pain; 2=mild pain; 3=moderate pain; 4=considerable pain; 5=unbearable pain) [6,7]. The parents were also asked for how many days their son took analgesics, or experienced a bad night's rest, and after how many days he recovered fully to normal daily home activity. After a minimum of 6 weeks the boys were seen again, and the parents' evaluation of the cosmetic result and a score on a scale of 1 (very bad) to 10 (extremely good) for the entire procedure obtained . Furthermore, the appearance of the penis was evaluated by three of the authors (R.S., T.S. and M.P.) as to the covering of the glans by the residual prepuce, and the length of the inner mucosal layer was measured.
Continuous data are expressed as the median (interquartile range, IQR). For analysing differences between groups for continuous data, Student's two-tailed t-test was used, and otherwise, if not normally distributed, a Mann–Whitney U-test was applied. The chi-square test, or if appropriate Fisher's exact test, was used to compare proportions. An anova for repeated measurements was used to compare Verbal Rating Scale scores of both groups in time; all reported P values are two-tailed.
Patients were included from October 1998 until June 1999; in Utrecht, 15 parents chose the CDT instead of the TCD. Thirteen boys were lost to follow-up, mostly because they had moved to an unknown address. The characteristics of the two groups are listed in Table 1. The operative characteristics, morbidity and cosmetic results are shown in Table 2. The median operative duration was 8 min longer for the CDT. In two TCD procedures it was necessary to convert to the CDT, once because the device disconnected spontaneously during the procedure and once because the clamp slipped directly after cutting the foreskin. One boy in the CDT group had to be re-operated on the same day because of bleeding. There was no bleeding in the TCD group when the clamp was in situ but in two cases bleeding had to be controlled with a suture after the clamp was removed on the fourth day. No clamp was removed earlier than intended and most of the inner tubes fell off on the day when the clamp was disconnected.
Table 1. Baseline characteristics of the boys
Median (IQR) age, years
Country of origin, n (%)
Table 2. Operative characteristics, morbidity and cosmetic results
0=day of operation; 1=first day after operation; 2=second day after operation, etc.
The postoperative pain was comparable in both groups, but the boys with the TCD had more disturbed nights and more analgesics were given (Fig. 4 and Table 2). However, they recovered earlier to normal daily home activity.
The cosmetic results were better in the TCD group, where the longer mucosal layer was appreciated by the parents. The parents' satisfaction score for the procedure, including the return for the removal of the clamp, was the same in both groups.
In the 20th century many circumcision clamps were developed for a quicker and safer procedure . Most of these are re-usable clamps in which the foreskin had to be crushed for several minutes before it was cut distally from the crushing zone. The only widely used disposable circumcision device is the Plastibell device® for neonatal circumcision. After the foreskin is pulled over this plastic bell, it is tied on the bell with a suture and subsequently cut. The bell is then snapped off, leaving the ring to slough off several days later. This technique is considered quick, easy and safe .
In 1996 the new TCD became commercially available; the advantages of its use are speed and reliable haemostasis directly after the procedure . However, some minor bleeding may occur after removing the clamp and the control of bleeding with a suture was required in two of the present cases, both older boys, aged 7 and 9 years. It is probably advisable to remove the clamp in older boys 1–2 days later than usual. Although a frank infection with pus was rarely encountered, there was often an inflammatory response, with redness of part of or all the penile skin and glans, when the clamp was disconnected. This was considered to be a result of the ischaemic injury, possibly a foreign-body reaction, as is also observed with the Plastibell®.
Although postoperative pain was comparable in both groups, nocturnal pain was more frequent with the TCD, which is why analgesics were given for longer. Interestingly, less daytime discomfort was experienced in the TCD group, presumably because the clamp protects the wound while the boy is mobile. A disadvantage of the clamp is the postoperative check needed to remove the clamp, which could cause discomfort and anxiety to the boy and his family.
Circumcision with the TCD more often caused a completely uncovered glans penis, but insufficient removal of the foreskin, defined in Muslim tradition as more than half-covering of the glans, occurred equally in both groups (4%) . In a series of consecutive conventional circumcisions in Australia, Leitch  found that 9.5% of operations had to be repeated because of inadequate skin excision during the initial procedure, but in a study in the UK only 1% were repeated . With a clamp circumcision it is essential to mark correctly beforehand the level of cutting (just proximal to the corona), as this decreases the risk of an incomplete circumcision. In the present study some of the parents even defined a redundant foreskin just covering the corona as ‘too long’, while others found it ‘a bit short’. Thus it may be wise to ask parents before circumcision about their preference for the length of the redundant prepuce. Although the inner mucosal layer was longer after the TCD, the parents did not qualify this as aesthetically unpleasant. Also, the absence of small scars from sutures, which are common after conventional surgery, was appreciated.
The study was not randomized as, during a pilot study, we considered that parents did not accept a random assignment of technique in this religious ritual, and therefore the present prospective comparison was devised. The results of a comparative study will be influenced by the comparability of the baseline characteristics. Although the two groups were not comparable in age and country of origin, within the groups there was no statistically significant difference in the items measured between those with a Turkish and those with a Moroccan background. Furthermore, the two clinics were completely comparable in organization and patient-recruitment methods, and only experienced doctors carried out the circumcisions.
In the Netherlands there will be an increasing shift towards extramural religious circumcisions in the future. Furthermore, the immigrant population will increase from the current 1.7 million to 2.7 million in the next 20 years; this will nearly double the demand for religious circumcisions . Consequently, more (non-hospital) outpatient clinics must be provided in the near future. In these clinics disposable circumcision devices like the TCD will be a valuable tool for efficient and safe circumcisions.
We thank W. Renooij PhD for drawing Figs 2 and 3. Note: For Taraklamp® supplies to the rest of the world except Europe: Taramedic Corporation Sdn Bhd, 146 Lorong Maarof, Bukit Bandaraya, 59000 Kuala Lumpur, Malaysia (e-mail: firstname.lastname@example.org). For Europe the address is: Taramedic Europe B.V., Strausslaan 15, 3723 JN Bilthoven, The Netherlands (e-mail: email@example.com).
Dr R.F. Schmitz, Department of Surgery, Green Heart Hospital, PO Box 1098, 2800 BB Gouda, The Netherlands. e-mail: firstname.lastname@example.org