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Journal of Pediatric Urology (2020) 16, 493.e1e493.

e6

Sutureless versus interrupted sutures


techniques for neonatal circumcision; a
randomized clinical trial
Department of Surgery, Faculty
of medicine Umm Al-Qura
Osama A. Bawazir *, Abdulaziz M. Banaja **
University, Makkah& King Faisal
Specialist Hospital & Research Summary 2 (2.27%) in groups 1 and 2, respectively, p Z 0.683).
Centre, Saudi Arabia
Cyst formation was significantly reduced in group 1
Introduction (2 (2.13%) vs. 13 (14.77%); p Z 0.002) and skin sinus
* Correspondence to: Osama A and objective: Male circumcision is a common pro- formation increased in group 2 (14 (15.91%) vs. 0 in
Bawazir, Department of
cedure all over the world; in Saudi Arabia, circum- group 2 and 1, respectively; p < 0.001).
surgery, Faculty of medicine in
Umm Al-Qura University at
cision is the most frequent elective surgical
Makkah, P.O.box 715, Makkah, procedure performed on males. The use of sutures
21955, Saudi Arabia. Tel.: for neonatal circumcision may decrease bleeding; Discussion
þ966125270000x4125 however, it may lead to skin sinus formation. The Circumcision can be performed with several tech-
objective of this study was to compare the suture- niques, and the superiority of one approach over the
** Correspondence to: less to the interrupted sutures technique for other is still debated. Many surgeons use interrupted
Abdulaziz M Banaja, King Faisal neonatal circumcision with Gamco clamp. sutures to oppose the skin edges, and in some re-
Specialist Hospital & Research ports, tissue glue was used for skin edges re-
Centre, Dept. of surgery, Saudi Patients and methods approximation with acceptable cosmetic results. In
Arabia. We performed a randomized controlled clinical trial our study, the mean time taken for sutureless
obawazir@yahoo.com, oaba- between 2017 and 2018. The study included 182 circumcision was about 7 min, and for the suture
wazir@uqu.edu.sa (O.A.
newborns assigned into two groups. Group 1 (n Z 94) circumcision, it took around 11 min. In addition, the
Bawazir)
Azizbanaja@hotmail.com (A.
included neonates who had sutureless circumcision, formation of a skin tunnel or sinuses rate was high
M. Banaja) and group 2 (n Z 89) included neonates who un- despite the use of very thin sutures.
derwent circumcision using interrupted absorbable
Keywords 6/0 sutures. Study endpoints were bleeding, wound
Male circumcision; Sutureless gaping, skin tunneling or sinus, and cyst formation. Conclusion
technique; Interrupted suture Male circumcision is a common and safe technique
technique Results with minor and treatable complications. Risks of
There was no significant difference in patients’ age bleeding and sinus track formation are low with the
Received 30 March 2020 and weight between groups. The procedure was sutureless method. The sutureless technique is rec-
Revised 17 June 2020 significantly longer in group 2 (12.24  2.17 vs. ommended after Gamco circumcision as the stan-
Accepted 20 June 2020 6.54  1.42 min; p < 0.001). There was no differ- dard technique for male circumcision in the
Available online 25 June 2020
ence in bleeding between both groups (4 (4.26%) vs. newborn.

Summary Table Comparison between duration of the procedure, early and late complications.

Group 1 (n Z 94) Group 2 (n Z 88) P-Value


Bleeding 4 (4.26%) 2 (2.27%) 0.68
Wound gaping 8 (8.5%) 1 (1.14%) 0.02
Skin tunnel/sinus 0 14 (15.91%) <0.001
Cyst formation 2 (2.13%) 13 (14.77%) 0.002
Procedure duration (minutes) 6.54  1.42 12.24  2.17 <0.001

https://doi.org/10.1016/j.jpurol.2020.06.025
1477-5131/ª 2020 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

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493.e2 O.A. Bawazir, A.M. Banaja

Introduction not aware of group allocation. Parents were not aware of


the circumcision technique at the time of the procedure.
Circumcision is the most frequent elective surgical pro-
cedure performed on males in Saudi Arabia, with circum- Patients
cision rates for newborn boys around 99% [1]. We perform
neonatal circumcision for social, cultural, personal, and A total of 286 newborn boys were screened for possible
religious reasons [2]. Male circumcision is common all over inclusion in the study. We excluded 101 patients; 47 were
the world, and in 2009, 54.5% of boys in the USA were older than four weeks, 53 refused randomization, and one
circumcised [3,4]. Neonatal circumcision has several po- patient had hypospadias. We allocated the patients into
tential benefits, and according to the American Academy of two groups according to the circumcision technique. Group
Pediatrics, it could decrease the incidence of urinary tract 1 (n Z 96) included newborns who underwent sutureless
infection and carcinoma of the penis [5,6]. The procedure circumcision, and Group 2 (n Z 89) included the patients
is relatively safe, and complications depend on the expe- who underwent circumcision using interrupted sutures. We
rience of the operator and the available equipment and used absorbable 6/0 polyglactin suture (Vicryl, Ethicon Inc,
supplies [7]. The objectives of circumcision are to remove Bridgewater, NJ, USA) in all patients.
the shaft skin and inner preputial epithelium enough to After randomization, three patients were excluded
uncover the glans and to prevent phimosis and render the because of loss for follow-up (2 in group 1 and one patient
development of paraphimosis impossible [8]. The Gomco in group 2). One-hundred eighty-two patients had per-
clamp is commonly used for neonatal circumcision, which protocol analysis (94 patients in group 1 and 88 patients in
provides a bloodless procedure, in addition to the accepted group 2). Three patients were lost for follow-up in both
cosmetic results [9]. groups and were excluded from the analysis. The loss of
Many research agreed that normal penile anatomy was follow-up was completely missing at random; therefore,
associated with good outcomes of neonatal circumcision the exclusion was an appropriate option. We excluded pa-
[10]. Parents wish to get excellent wound healing with no tients older than four weeks (n Z 47), patients with
complications and the best cosmetic results. For decades, congenital anomalies (n Z 1), and patients who refused to
circumcision has been performed without sutures with be enrolled (n Z 53). Fig. 1 shows the study flowchart.
acceptable results. One of the significant concerns about
the use of sutures in neonatal circumcision was the devel- Study endpoints
opment of stitch sinus, especially with the use of larger
sutures, and there is a strong belief in our community The primary endpoint was cyst/sinus formation. Short-term
against the use of sutures for neonatal circumcision secondary outcomes were postoperative bleeding, infec-
because of this belated sequel. We hypothesized that the tion, wound gaping, and urinary retention. Long-term sec-
rate of sinus and cyst formation is different between ondary outcomes were foreskin adhesions, redundant
sutureless and interrupted sutures technique for neonatal foreskin, and buried penis, and incomplete circumcision.
circumcision. Therefore, the objective of this study was to
compare the sutureless to the interrupted sutures tech- Sample size calculation
nique for neonatal circumcision with Gamco clamp.
We designed the study to include two groups of indepen-
dent cases and controls with 1:1 allocation. If the rate of
Patients and methods cyst and sinus formation in the interrupted suture tech-
nique is 0.14 and their rate in the sutureless method is 0.01,
Design we will need to study 78 cases assigned to each group to be
able to reject the null hypothesis with probability (power)
The research is a randomized controlled clinical trial that 0.8 and the Type I error probability associated with this test
included all newborn scheduled for circumcision in our of this null hypothesis is 0.05.
clinic between January 2017 and January 2018. The study
was conducted at the Pediatric Surgery Clinic, Jeddah, Surgical technique
Saudi Arabia. The Ethics Committee approved the study
(protocol number 051) and written informed consent was Physical examination was performed before circumcision to
obtained from the parents or guardians before randomiza- identify congenital anomalies and exclude patients not
tion. Both techniques were equally performed in our insti- fulfilling the study criteria (age less than four weeks).
tution, and there was no preference for either technique. Paracetamol drops (15 mg/kg) were used as a pre-
medication, and anesthetic cream was applied locally.
Well-trained pediatric surgeons performed all circumcisions
Randomization and blinding using a circumcision board and Gomco clamp. Local anes-
thetic cream was used. The procedure commenced with
Simple randomization was used to assign patients into freeing the glans from the inner prepuce and cleaning the
either group. Closed envelopes were made containing both smegma with chlorhexidine solution. We performed a dor-
treatments prior to commencing the study. The patients sal slit to expose the glands. Prepuce was held at 12 and 1’
were blindly assigned into either treatment groups, and the O’clock position with two artery forceps. An appropriate
nurses who collected the data, and the biostatistician were size metal bell was introduced between the two artery

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Sutureless versus interrupted sutures circumcision 493.e3

Figure 1 The study flowchart.

clamps and was placed over glans, and the prepuce was dressing, which was removed after 24e48 h. We educated
drawn through the ring of the plate. The clamp was the parents about the warning signs and instructed them to
assembled so that the prepuce was maintained between have bathing from day three after surgery.
the ring and bell. As the nut of the clamp got tightened, the
crushing force was applied to the prepuce, and this was
maintained for 30 s to achieve hemostasis (Fig. 2). Prepuce Statistical analysis
was excised with a surgical blade; then, the nut was
released. The clamp was removed carefully, and the pro- We presented the continuous variables as mean and stan-
cedure was completed. The difference between the two dard deviation and categorical variables as number and
groups was the technique of wound closure. Four-corner percent. Continuous data were compared using a t-test or
interrupted sutures were used for wound closure using 6/ ManneWhitney test and categorical data using Chi-square
0 absorbable sutures. We observed all patients for 20 min in or Fisher exact test if the expected frequency was less than
the immediate postoperative period. Follow-up was 5. A p-value of less than 0.05 was considered statistically
scheduled on the 7th postoperative day, then after one, six, significant. Statistical analysis was performed with Stata 16
and 24 months postoperatively. Both groups had wound (Stata Corp- College Station- TexaseUSA).

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493.e4 O.A. Bawazir, A.M. Banaja

Figure 2 Shows the hemostatic effect of Gomco clamp in the sutureless technique.

There was no significant difference in patients’ age and wound gapping was slightly higher in group 1 (RR: 7.49; 95%
weight between both groups (Table 1). The procedure was confidence interval: 0.96e58.67). The risk of sinus forma-
significantly longer in group 2 (p < 0.001). tion increased in group 2 compared to group 1 (RR: 14.95,
95% confidence interval: 2.01e111.37). No patient had
foreskin adhesions, redundant foreskin, or buried penis.
Results Postoperative complications are presented in Table 2.

Thirteen patients (out of 27 patients) had cyst/sinus repair.


There was no difference in bleeding between both groups
(Risk ration (RR): 1.87; 95% confidence interval: Discussion
0.35e9.97). No patient had wound infections nor urine
retention. Circumcision can be performed with several techniques,
All patients were followed for six months. Risk of cyst and the superiority of one approach over the other is still
formation was significantly reduced in group 1 (RR: 0.144; debated. Many surgeons use interrupted sutures to oppose
95% confidence interval: 0.03e0.62) (Fig. 3). The risk of the skin edges, and in some reports, tissue glue was used
for skin edges re-approximation with acceptable cosmetic
results [11,12]. We compared the sutureless and inter-
Table 1 Baseline patients’ data. Continuous variables are rupted sutures technique for neonatal circumcision, and
presented as mean and standard deviation (Group 1 the rate of sinus and cyst formation was higher in patients
included patients with sutureless technique and group 2 who had sutures.
included patients who had interrupted sutures Circumcision has potential complications, including
circumcision). bleeding, infection, wound dehiscence, meatal stenosis, a
cosmetic failure because of abnormal scarring, penile
Group 1; Group 2; P-Value injury, such as glandular necrosis and glans and penis
sutureless interrupted amputation, and urethral injury, such as urethra-cutaneous
(n Z 94) sutures fistula [13,14].
(n Z 88) In general, the reported complications are less frequent
Age (days) 11.22  7.22 12.43  7.84 0.35 among neonates and infants than among older boys, and
Weight (kg) 2.84  0.365 2.87  0.34 0.40 most prospective studies in this age group did not report
Procedure 6.54  1.42 12.24  2.17 <0.001 serious complications, with only minor and treatable
duration adverse events [7]. This low incidence of complications
(minutes) among neonates could be attributed to the minimal activity
in the newborn, which promotes wound healing.

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Sutureless versus interrupted sutures circumcision 493.e5

Figure 3 Shows the suture technique with cyst and sinus formation.

The expected complication rate ranges from 0.19% to however, the risk is still present, and in this study, the rate
3.1%, with higher complication rates occurring beyond the was high despite the use of very thin sutures.
neonatal period [15]. Late complications do occur and The use of dressing did not affect the complication rates
fortunately are usually minor. Most late complications of other penile surgery, and it is unlikely to affect the
involve adhesions, skin bridges, incomplete circumcision complications after circumcision [19]. We believe that
with the uncircumcised appearance, and meatal stenosis dressing carries an essential role in stabilizing the wound in
[16,17]. Major complications are extremely infrequent. the first 24e48 h, which gives time for clot formation and
Bleeding is the most common complication of circumci- starts the healing process.
sion [18]. Bleeding can occur at different points during In our study, the mean time taken for sutureless
circumcision and typically happens from the vessels of the circumcision was about 7 min, and for the suture circum-
dorsal dartos fascia at the preputial excision line or from cision, it took around 11 min. Elmore and colleagues re-
the frenulum. Bleeding can be managed with direct pres- ported that their standard suturing time was approximately
sure or with the application of silver nitrate to the bleeding 10 min [11]. Therefore, the sutureless technique has a
point. Re-exploration is rarely required in case of hema- time-saving advantage. Reducing the procedure time might
toma formation, and in patients with persistent bleeding, reduce the circumcision cost, in addition to saving the cost
coagulation screening is recommended. In our study, we did of sutures.
not find a significant difference in bleeding between both World Health Organization has introduced male medical
groups. circumcision as a human immunodeficiency virus (HIV)
In Saudi Arabia and most Muslim countries, circumcision preventive method [20]. Recent data stating that circum-
was performed without sutures to approximate the skin cision confers significant protection against the spread of
edges and using primitive instruments. Most of the old and HIV has raised considerable interest in the procedure [21].
middle-aged men who were circumcised with the tradi-
tional method had excellent cosmetic results. In the early
Study limitations
experience of suture circumcision in our country, larger-
sized sutures (2/0) had delayed absorption with an
increased incidence of skin sinuses and cyst formation at There are several limitations of the study, including lack of
the site of circumcision. Therefore, there is a strong belief blinding; however, parents and the process of data collec-
in our community that the sutureless technique is far better tion and analysis were blinded. Another limitation is the
than the interrupted suture technique, and the parents randomization method since we used simple randomiza-
typically request circumcision without suture. This was the tion; the number of patients in each group was not equal.
rationale for performing the present study to compare the The study included patients aged less than four weeks;
outcomes between sutureless and suture techniques. therefore, the generalization of the results to all ages is not
In neonates, the skin is thin, and the movement of the feasible.
newborn is minimal, in addition to this, the crushing effect
of the Gomco clamp decreases the incidence of major
Conclusion
bleeding in this group of patients. On the other hand, the
healing rate in neonates is fast, and the formation of a skin
Male circumcision is a common and safe technique with
tunnel or sinuses is common. With the use of rapidly
minor and treatable complications. Risks of bleeding and
absorbed suture, the formation of skin sinuses decreases;
sinus track formation are low with the sutureless

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493.e6 O.A. Bawazir, A.M. Banaja

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authors declare that they have no competing interests. tion 6-8 March 2007 conclusions and recommendations (Ex-
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