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- Original Article -
Clinical application of a new device for minimally invasive circumcision
Yi-Feng Peng1, Yue Cheng2, Guo-Yao
Wang2, Suo-Qun Wang3, Chao
Jia1, Ben-Hai Yang1, Ru
Zhu1, Shu-Chuan Jian4, Qing-Wen
Li5, Da-Wei Geng6
1Department of Sexual Medicine,
4Department of Urology, Yijishan Hospital, Wannan Medical College, Wuhu 241001,
China
2Center of Urology, Ningbo The First Hospital, Ningbo 315010, China
3Department of Urology, Beijing General Hospital of The Chinese People's Armed Police Forces, Beijing 100039, China
5Department of Urology, Affiliated Hospital of Bengbu Medical College, Bengbu 233000, China
6Department of Urology, Wuhu First People's Hospital, Wuhu 241001, China
Abstract
Aim: To study the clinical effects of a disposable circumcision device in treatment of male patients of different ages
with either phimosis or excess foreskin. Methods:
One thousand two hundred patients between the age of 5 and 95
years underwent circumcision using this procedure in the 2-year period between October 2005 and September 2007.
Of these cases, 904 had excess foreskin and 296 were cases of phimosis.
Results: In 96.33% of the cases the incision healed, leaving a minimal amount of the inner foreskin with no scarring and producing good cosmetic results.
There were no incidents of device dislocation or damage to the frenulum. The average operative time was 2.5 min for
excess foreskin, and 3.5 min for phimosis. During the 7 days of wearing the device, mild to moderate edema
occurred in 10.08 % of cases with excess foreskin and in 2.58 % of those with phimosis. Edema in the frenulum was
seen in 1.67% of patients, and only 0.67% had an infection of the incision. A total of 86.25% of patients reported pain
due to penile erection. After removal of the device, 0.58% of the cases had minimal bleeding around the incision, and
2.42% had wound dehiscence. Conclusion: The new device can be applied to an overwhelming majority of patients
with phimosis and excess foreskin. This technique is relatively simple to perform, and patients who underwent this
surgery had very few complications. Antibiotics were not required and patients reported less pain than those who
were circumcised using conventional methods. Circumcision with this device requires minimal tissue manipulation,
and is quicker and safer than circumcision using conventional techniques.
(Asian J Andro 2008 May; 10: 447_454)
Keywords: excess foreskin; phimosis; circumcision device
Correspondence to: Dr Yi-Feng Peng, Department of Sexual Medicine, Yijishan Hospital, Wannan Medical College, Wuhu 241001, China.
Tel: +86-553-5739-327 Fax: +86-553-5738-279
E-mail: yifengpeng@yahoo.cn
Received 2007-11-26 Accepted 2008-02-26
DOI: 10.1111/j.1745-7262.2008.00411.x
1 Introduction
Male circumcision has been practiced on a large scale for more than 5 000 years [1] as a way to remove the
redundant foreskin in order to expose the glans. The benefits of circumcision include easier urination, improved
penile topical hygiene, and increased sexual pleasure. In addition, a World Health Organization/Joint United Nations
Programme on HIV/AIDS (UNAIDS) evaluation of recent res
earch, conducted in Africa, concluded that circumcision
can reduce the risk of men becoming infected with HIV
by approximately 60% [2]. Male circumcision is
practiced worldwide for medical, cultural, and religious
reasons. Regardless of why it is carried out,
circumcision should be done in a way that reduces unnecessary
suffering. Although circumcision is easy to perform [3],
complications may result if the procedure is not done
properly. The introduction of new, easy-to-use
circumcision devices has made it possible to improve the
results of the operation, prevent infection, and reduce pain
in patients. Along with our colleagues from hospitals on
the Chinese mainland, we have been using a newly
invented disposable circumcision device (Shenghuan
Disposable Minimally Invasive Circumcision Anastomosis
Device; China Wuhu Snnda Medical Treatment Application Technology Co.
Ltd., Wuhu, China) for treating patients with phimosis and excess foreskin, and have
achieved satisfactory results.
2 Materials and methods
2.1 Clinical data
One thousand two hundred patients with phimosis
or excess foreskin underwent circumcision using this
new disposable device. The group included children
between the ages of 5 and 12 years (n = 160), teenagers
aged 13 to 17 years (n = 440), adults between the ages
of 18 and 60 years (n = 534 ), and elderly patients
between the ages of 61 and 95 years (n = 66). According
to medical records, 296 out of the 1 200 cases were
phimotic and 904 had excess foreskin. In the phimosis
group, there were 120 children, 128 teenagers, 32 adults,
and 16 elderly patients. In children with phimosis, 93
had experienced concretions beneath the foreskin. All
participants were provided with information about the
benefits and risks associated with the procedure, and
were required to sign an informed consent form before
being enrolled in the study.
2.2 Circumcision device
The Shenghuan Disposable Minimally Invasive Circumcision Anastomosis Device was invented by Shang
Jianzhong (China Wuhu Snnda Medical Treatment
Application Technology Co. Ltd.) and was granted domestic
patent approval (Patent No. ZL200320124901.9; PCT/CN2003/000903). International patents are pending. The
device is made of medical grade polymers imported from
the USA. Weighing from 2.8 g to 8 g, the device
consists of an inner and outer ring, a silicon rubber gasket,
and a fastener (Figure 1). The inner ring serves as a frame
for the device, which comes in 13 sizes, based on its
inside diameter. The sizes are as follows: A2 (40 mm), A1
(37 mm), A (34 mm), B (32 mm), C (30 mm), D (28 mm),
E (26 mm), F (24 mm), G (22 mm), H (20 mm), I (18 mm),
J (16 mm), and K (13 mm). The outer ring is made of
two linked semicircular pieces with cutting blades
attached to the inner surfaces. The devices are
hermetically sealed in a foil-covered paper bag and sterilized by
γ-ray radiation.
2.3 Methods
2.3.1 Examination of foreskin
The area under and around the foreskin was
examined for inflammation and warts and assessed to see
whether it could be pulled over and stretched. Surgical
contraindications were defined as the presence of acute
inflammation, uncontrolled diabetes mellitus, and concealed
penile phimosis related to balanitis xerotica obliterans.
Males born with penile anomalies (hypospadias, epispadias, or
megalourethra) and children with ammonia dermatitis
were also excluded from the study. Caution is required
for indications for circumcision, especially in children,
as the protective role of the foreskin is not always
understood. Excess foreskin is only a surgical indication for
children's circumcision when the foreskin is long enough
to lead to recurrent irritation and discomfort from
retention of urine inside the sac.
2.3.2 Measurement of circumference
A specially prepared measuring tape was used to
measure the circumference of the penis at the level of
the coronal sulcus in order to select the appropriate
device size. For instance, if penile circumference at the
coronal sulcus was at the C point on the measuring tape
(Figure 2), device model type C was used.
2.3.3 Disinfection and anesthesia
Disinfection was accomplished by applying
disinfectant iodophor or 0.05% chlorhexidine acetic solution
around the penis and involved tissues and by covering
the operative site with a surgical drape. The dorsal
penile nerve was blocked by a local anesthetic solution of
1% lidocaine using a 24-gauge needle. The recommended
anesthetic dose varied from 3 mL to 5 mL.
2.3.4 Placement of device and fixation
Once the penis was completely anesthetized, the
inner ring was placed on the shaft (Figure 3). Next, the
rim of the foreskin was clamped with blood vessel
forceps at the 3, 6, 9 and 12 o'clock points (Figure 4). A
urologist and an assistant each held two clamps to widen
the opening of the foreskin, and pulled it over the inner
ring (Figure 5). After the inner and outer layers of the
foreskin and the frenulum were symmetrically positioned,
the assistant installed the outer ring over the foreskin and
gently screwed it together. Finally, they verified that 0.5 cm
of the inner foreskin lining and an adequate frenulum
were preserved (Figure 6). In cases with phimosis, a
dorsal slit of the foreskin must be made after binding the
root of penis with a rubber band. The dorsal foreskin
should be cut deep enough to be pulled over the inner
ring (except in the case of phimosis related to balanitis
xerotica obliterans, where the procedure would be contraindicated). The procedure can then be carried out
as described above.
2.3.5 Removal of excess foreskin
Excess foreskin is then cut by stretching the
foreskin to just below the circumcision device with the aid
of blood vessel forceps. Four or five relieving incisions
must be made with a sharp knife at the end of the
remaining foreskin (Figure 7).
2.3.6 Postoperative management
Oral painkillers were recommended for postoperative pain. Oral use of diethylstilbestrol at a dose of 2 mg
per night can prevent nocturnal erection of the penis.
2.3.7 Removal of circumcision device
The circumcision device was removed 7 days after
the procedure. Its position and the edges of the wound
were checked. To remove the device, the following steps
were taken: 1) the screw was gently unfastened and the
outer rings removed (Figure 8); 2) the inner ring by the
rim of incision was pushed carefully backward; and 3)
the ring was cut with special sulcate scissors and
removed (Figure 9).
2.3.8 Protective dressing
A specially prepared wound dressing (Figure 10) is
recommended to keep the necrotic skin tissues from
rubbing against the scrotum.
3 Results
In a total of 1 200 cases of circumcision in male
patients with phimosis or excess foreskin, 96.33% had
primary wound healing of the incision with a straight
margin. The frenulum remained flexible and intact, and
a minimal layer of the inner foreskin was left, producing
good cosmetic results (Figure 11). There were no
incidents of device dislocation or injury to the frenulum in
any of the cases. The average duration of the procedure
for cases with excess foreskin was 2.5 min compared
with 3.5 min for cases with phimosis. Although the
patients suffered pain from wearing the device on the day
of the procedure, it was relieved by oral painkillers and
subsided within 24 h.
Complications that occurred while the patients were
required to wear the device are listed in Table 1. Most
men reported pain at night associated with nocturnal
erections despite, the suggested use of an anti-androgen.
However, the pain was tolerable and no devices needed
to be removed for this reason. Table 2 shows the
complications that occurred after the device was removed.
4 Discussion
Conventional circumcision may result in
complications due to postoperative disturbance of circulation of
the inner foreskin layer. This can result in edema that
could delay the healing of the wound [4]. Hemostasis by
ligation is necessary to treat subcutaneous bleeding.
Furthermore, sutures might cause pain or dyspareunia,
and potential intra-operative or postoperative bleeding
could cause secondary infections. Because the wounds
are close to the urethral orifice, the dressings are likely
to be wet by urination. These damp conditions are
favorable to bacterial infection around the wounds, chiefly
at the junction of the frenulum and the urethral orifice,
and hematomas and hydrops are likely to cause local
inflammation.
Technicians in medical instrument research and
development have invented a new circumcision device that
can reduce morbidity associated with this procedure. The
Shenghuan Disposable Minimally Invasive Circumcision
Anastomosis Device is superior to other recently invented
devices because of its unique structure. The uniform
force from both outer rings created by this device can
result in ischemic necrosis of the tissues clamped
between the inner and outer rings and spontaneous
anastomosis of the incised rim with no injury to the frenulum.
Sutures and antibiotics are not required because there is
no bleeding during the procedure and very few
complications have been reported. Patients can follow their
normal daily routines, and can even bathe while the
device is still attached. Recovery time is approximately 1
week. The cosmetic results were good, with an even
linear rim and uniform inner and outer foreskin layers
after the scab fell off 10_14 days after the removal of
the device. Considering the tender condition of the
frenulum in children, conventional circumcision tends to result
in bleeding, segmentation, hematoma, or sclerosis of
penile frenulum if it is improperly managed. Fortunately,
this new device can provide children with a safer
circumcision (Figure 12). Our device is superior to the
Korean style of circumcision (Korea Good Man CDS-8;
Korea GM Medical Corp.; Seoul, Korea). The Korean
device locates the inner ring around the coronal sulcus
under the foreskin, making it difficult to precisely
measure the length of the frenulum. Having an unexposed
coronal sulcus after the procedure can create warm and
humid conditions that could encourage bacterial growth.
Inflammation around the sutures might also lead to the
growth of bacteria. Antibiotics are often required to
prevent postoperative infection, because the incision is so
close to the external orifice of the urethra that it is easily
infected by urine.
Together with health providers from different
hospitals, we have performed circumcisions using the
Shenghuan Disposable Minimally Invasive Circumcision
Anastomosis Device in 1 200 cases, and no incidents of
significant bleeding or device dislocation have occured. Both
the silicon rubber gasket on the inner ring and the cutting
blade attached to the inner side of the outer ring can
exert moderate and persistent force on the clamped
tissues. This ensures that the tissues will not be cut off
due to excessive force from the outer rings, and that the
wound margin tissues of both inner and outer foreskin
layers will not slip. Bleeding control and blockage and
apposition of both inner and outer foreskin layers are
carried out once the device has been set. All patients
underwent local anesthesia for the procedure. The data
show that this device can be used for circumcision in
male patients aged 5_95 years. In cases of children, the
procedure can be carried out if the child can tolerate a
local anesthesia. A dose of 3 mL of 1% lidocaine will
facilitate the procedure, but 5 mL of 1% lidocaine is
recommended for teenagers, young adults and elderly
patients. Dorsal penile nerve block requires a minimum
of 0.5 mL of anesthetic without additional epinephrine
1:1 000. Not a single case of ischemic glans penis was
seen in our clinical experience, as reported by Tzeng
et al. [5] when the dorsal penile nerve block was introduced.
The average duration of the procedure was 2.5 min for
patients with excess foreskin, and 3.5 min for phimotic
cases. In contrast, it took Zhao et al. [6] an average of
9 min to perform a circumcision using the Korean device.
Circumcisions done without the aid of a device commonly take as long as 20_30 min [7].
Pain might arise from the circumcised site when the
anesthesia loses its effect after the procedure, but it can
be relieved by an oral painkiller and will usually disappear
on day 2 after the operation. The lightweight, smooth
device is comfortable for the patient to wear and does
not cause interference with urination or daily activities.
The inner diameter of the device is larger than the penis,
which should reduce or prevent nocturnal pain from
erection. There was reported pain from nocturnal
erections in 78% of patients, but pain can be lessened by oral
use of diethylstilbestrol before bed-time.
Selecting the appropriate device size is very
important in order to prevent postoperative complications. This
selection is facilitated by using a measuring tape to
measure the penis. If the inner ring is too large, it will be
difficult to pull the foreskin over and around the inner
ring and insufficient tissue will be resected. If the inner
ring is too small, it will lead to constriction during
nocturnal erection, producing disturbance of the blood
flowing back to the glans. Although Cheng et
al. [8] reported complications in a study of circumcision in adults using
a plastic ring that compressed the external urethra and
caused dysuresia and pain, this was attributable to a ring
that was too tight, and these complications were not
observed in our study.
In 10.08% of the cases, complications arose with
mild edema of the inner layer of the foreskin, a condition
that spontaneously disappeared shortly after the ring was
removed. Incidents of moderate edema were seen in 2.58%
cases and were drained with a needle. Mild edema in the
frenulum was observed in 1.67% of cases, but the
symptom subsided within 3 to 4 weeks of removal of the rings.
In a study that used the Korean style of circumsion, Ge
and Liu [9] reported complications in 50% of adult cases,
with mild to moderate edema in the rim of the foreskin.
Comparatively, the rate of edema in our study was
significantly lower. We observed only 0.67% cases of
infection around the incision. The infection involved
phimotic chronic inflammation or inflammatory hyperplasia and
the wounds were healed by oral antibiotics and by
changing the dressings. The infection rate was lower than the
8.2% associated with the conventional procedure
circumcision as reported by Rizvi et al. [10].
Adherence of the foreskin to the coronal sulcus of
the glans, and effusion of slight yellowish fluid from the
disjuncting layer was observed in some children with
phimosis on the day the device was attached. Scab
formation is regarded as a natural condition, and scabs will
usually fall off from the surface of glans in 4_5 days
after surgery.
Incision bleeding following the removal of the
device was seen in two teenagers and five adults,
accounting for 0.58% of the total cases. This was caused by
repeated rubbing against underwear when walking, torn
wounds due to incomplete healing, or the expansion of
blood vessels during erection. Complete hemostasis was
achieved by local compression with cotton swabs in two
cases. One suture at the site of bleeding was required in
five cases. In contrast, in a study of circumcision using
the Plastibell device (Hollister Inc., Seattle, Washington,
USA), Lazarus et al. [11] found bleeding to be the most
common complication (7/16 cases or 44%) among cases
presenting at the hospital after circumcisions done
outside the hospital. Among 79 in-hospital cases, one had a
significant bleeding complication.
Wound dehiscence of the incision, commonly seen
during or following the night of device removal, was caused
by nocturnal erection. Three consecutive days of
medication by diethylstilbestrol, right after the removal of the
device, can prevent dehiscence of the incision. Would
dehiscence was observed in 2.24% of cases with this wound
measuring from 3 to 5 mm wide. Sutures were not needed,
and the wounds were treated by closing the incised rim
with a butterfly adhesive plaster and topical disinfection,
which healed the wound within a week.
Circumcision using a device like this one is an
improvement on conventional surgical techniques. The
essential purpose of using this device for circumcision is
to improve the quality of the operation, make the
procedure easier, prevent infection, and reduce pain. The
Shenghuan Disposable Minimally Invasive Circumcision
Anastomosis Device serves this purpose. Compared with
conventional and Korean styles of circumcisions, this
device distinguishes itself because it is quick, relatively
simple and safe. Fewer complications and less pain were
observed than in conventional circumcision. Patients did
not experience discomfort with the device, which is
lightweight and smooth. The foreskin was folded back, so
the layers were further from the external urethral meatus,
thus reducing exposure to bacterial infection. The linear
and even cut produced good cosmetic results as well as
meeting requirements for circumcision with minimal
tissue manipulation. Additional research is needed to: 1)
better evaluate pain severity associated with nocturnal
erections without the use of an anti-androgen, or with
the use of other anti-androgens, as the use of
diethylstilbesterol might not be acceptable in other settings; and 2)
evaluate use of the device in African countries with high
HIV prevalence. This device deserves wide clinical
application and evaluation in other settings.
Acknowledgment
The project (The Fundamental Researches of the Reproductive Health) was supported by the National
Natural Science Foundation of China (G1999055905, branch topic).
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