Global Surgery & Anesthesia

Dear Dr. Millard and others,

We have recently completed a randomized clinical trial of Mogen Clamp versus Plastibell in boys < 29 days of age (neonates). This study examined uptake, safety, feasibility and sustainability of neonatal circumcision in Botswana. Each method has pros and cons but overall we felt for a rural population the Plastibell would not be safe due to potential to migrate proximately and obstruct urine, etc, as you mentioned, which would ultimately be a threat not only to the infants' safety but also to the sustainability of a neonatal male circumcision program. Please see our abstract from CROI 2011 that summarized the findings from the first 100 babies (the full manuscript that will include outcomes for 300 babies is in preparation):

http://retroconference.org/2011/Abstracts/41625.htm

We excluded the Gomco from the trial because of the potential problems with the 1) four components we were not confident we could keep together through the cleaning process 2) known risk for mismatching a larger base-plate with a smaller bell and inadvertently lacerating the penis. Nonetheless although it is a little more cumbersome than the Mogen, if used properly is very likely safer.

After starting the above trial a ...

Dear Dr. Millard and others,

We have recently completed a randomized clinical trial of Mogen Clamp versus Plastibell in boys < 29 days of age (neonates). This study examined uptake, safety, feasibility and sustainability of neonatal circumcision in Botswana. Each method has pros and cons but overall we felt for a rural population the Plastibell would not be safe due to potential to migrate proximately and obstruct urine, etc, as you mentioned, which would ultimately be a threat not only to the infants' safety but also to the sustainability of a neonatal male circumcision program. Please see our abstract from CROI 2011 that summarized the findings from the first 100 babies (the full manuscript that will include outcomes for 300 babies is in preparation):

http://retroconference.org/2011/Abstracts/41625.htm

We excluded the Gomco from the trial because of the potential problems with the 1) four components we were not confident we could keep together through the cleaning process 2) known risk for mismatching a larger base-plate with a smaller bell and inadvertently lacerating the penis. Nonetheless although it is a little more cumbersome than the Mogen, if used properly is very likely safer.

After starting the above trial a new device came to our attention called AccuCirc. We are currently enrolling in a single-arm trial of this device in Botswana. It has many important safety advantages over other clamps including coming in a totally self-contained and sterilized pack which reduced problems with supply chain management and eliminates potential problems with disinfecting instruments. There are no "retained" parts which is a great advantage over the Plastibell and it is VERY easy and safe to learn to use. Here is the link to the official web-site for the device:

http://www.accucirc.com/

This device is FDA approved for boys up to 10 days of age.

There are other details that deserve discussion such as clean versus sterile procedure, EMLA (topical cream) anesthesia versus injectable, and the very best time for the procedure.

It is likely the WHO will recommend the procedure be limited to babies up to 60 days and after that boys should be circumcised under local anesthesia when they are old enough to cooperate with the procedure.

I welcome questions or comments about our work and look forward to further discussion.

Thank you,

Rebeca Plank

Thank you very much for your thoughtful comments, Rebeca. We have debated the pros and cons of the 3 methods (Gomco, Mogen, and Plastibell) for neonatal circumcision in the US for many years and there is still no consensus! While there could be a problem with mismatching the parts, I never found that to be a problem in nearly 30 years. It did happen a couple of times, but never harmed a patient. It is a potential problem, though, and the manufacturers should color-code the different sizes to prevent mismatching. Plastibell really doesn't migrate in the neonatal period. It is later, when boys have erections that migration occurs.
Unfortunately, neonatal circumcision is almost unknown in Africa, and we must change that, because it is the ideal time to do it. Your study was helpful in showing that moms are open to the idea, and embrace it. We surveyed antenatal nurses in Mozambique and none had even heard of neonatal circumcision.
Childhood and adult circumcisions are here to stay and we must develop simpler and less expensive methods. Does anyone out there use tissue adhesive in childhood and adult circs? Several studies have shown them to be advantageous. Gomco and ...

Thank you very much for your thoughtful comments, Rebeca. We have debated the pros and cons of the 3 methods (Gomco, Mogen, and Plastibell) for neonatal circumcision in the US for many years and there is still no consensus! While there could be a problem with mismatching the parts, I never found that to be a problem in nearly 30 years. It did happen a couple of times, but never harmed a patient. It is a potential problem, though, and the manufacturers should color-code the different sizes to prevent mismatching. Plastibell really doesn't migrate in the neonatal period. It is later, when boys have erections that migration occurs.
Unfortunately, neonatal circumcision is almost unknown in Africa, and we must change that, because it is the ideal time to do it. Your study was helpful in showing that moms are open to the idea, and embrace it. We surveyed antenatal nurses in Mozambique and none had even heard of neonatal circumcision.
Childhood and adult circumcisions are here to stay and we must develop simpler and less expensive methods. Does anyone out there use tissue adhesive in childhood and adult circs? Several studies have shown them to be advantageous. Gomco and tissue adhesive sounds like a good combination in children and adults to me.
The problem with plastic rings is cost and availability.
Dr. Peter Millard
Catholic U of Mozambique
Beira

This is a very useful discussion. Arguably, circumcision is the commonest surgical procedure worldwide, but it continues to be an unsafe intervention - I have personally seen several children with post circumcision complications, including mortality secondary to severe bleeding. In a predominantly Muslim country like Pakistan, where practically every male is required to undergo a circumcision, neonatal circumcisions are not the norm. While the advantages of Gomco, plastibell and Mogen techniques are debated and a consensus has yet to be reached, it is reasonably clear that circumcisions are safest when performed during the neonatal period or during early infancy. The emphasis must be on promoting early circumcisions, performed by trained health workers.

The individual technique used may well vary. Given that there is no consensus on the "best" technique, the surgeon or group should opt for the technique they are most comfortable using, and that has yielded the safest results for that group. I use plastibell for children age 1 year and below, after that I find that the chances of problems increase. Additionally, it becomes increasingly traumatic (for me!!) to do this procedure under local anesthetic on an older struggling child, and I always opt for a short and safe ...

This is a very useful discussion. Arguably, circumcision is the commonest surgical procedure worldwide, but it continues to be an unsafe intervention - I have personally seen several children with post circumcision complications, including mortality secondary to severe bleeding. In a predominantly Muslim country like Pakistan, where practically every male is required to undergo a circumcision, neonatal circumcisions are not the norm. While the advantages of Gomco, plastibell and Mogen techniques are debated and a consensus has yet to be reached, it is reasonably clear that circumcisions are safest when performed during the neonatal period or during early infancy. The emphasis must be on promoting early circumcisions, performed by trained health workers.

The individual technique used may well vary. Given that there is no consensus on the "best" technique, the surgeon or group should opt for the technique they are most comfortable using, and that has yielded the safest results for that group. I use plastibell for children age 1 year and below, after that I find that the chances of problems increase. Additionally, it becomes increasingly traumatic (for me!!) to do this procedure under local anesthetic on an older struggling child, and I always opt for a short and safe general anesthetic.

Dear Dr Millard and others,
I am not a surgeon nor a medical doctor but i am interested by this discussion. I am an HIV prevention research advocate.
Even if most of the sub-saharan african countries are rolling out male circumcision in adults as catch-up campaigns, some of these countries are considering infant circumcision for cost-effectiveness and other reasons. I have few questions for you:
- Is there a difference between neonatal and infant circumcision (i am a little confused)?
- If doctors are struggling to find the simplest technique, how will mothers and parents in the community choose a technique to be used while circumcising their boys or maybe, they are not part of the decision, the doctor make the decision himself? If parents are part of the decisions, on which factors should they based their choice?
- You asked if there is anyone who has experimented super glue instead of sutures. Is it the super glue used for shoes for example? If there is anyone who has used super glue instead of sutures, how did the parents reacted to that? Is the effect of super glue long lasting or maybe, at some point/time, the skin can detach itself?
- What is ...

Dear Dr Millard and others,
I am not a surgeon nor a medical doctor but i am interested by this discussion. I am an HIV prevention research advocate.
Even if most of the sub-saharan african countries are rolling out male circumcision in adults as catch-up campaigns, some of these countries are considering infant circumcision for cost-effectiveness and other reasons. I have few questions for you:
- Is there a difference between neonatal and infant circumcision (i am a little confused)?
- If doctors are struggling to find the simplest technique, how will mothers and parents in the community choose a technique to be used while circumcising their boys or maybe, they are not part of the decision, the doctor make the decision himself? If parents are part of the decisions, on which factors should they based their choice?
- You asked if there is anyone who has experimented super glue instead of sutures. Is it the super glue used for shoes for example? If there is anyone who has used super glue instead of sutures, how did the parents reacted to that? Is the effect of super glue long lasting or maybe, at some point/time, the skin can detach itself?
- What is the best age frame to circumcise children and why?

Thanks,
Alliance

Dear Alliance,

Neonatal circumcision refers to the procedure done in neonates, that is
according to the medical definition of up to 28 days of life (first 4 weeks of
life).

Infancy is strictly defined as the first year of life, and WHO advocates for the
procedure in EARLY infancy. WHO is currently recommending in their Manual for
Early Infant Male Circumcision Under Local Anesthesia
(http://www.who.int/hiv/pub/malecircumcision/manual_infant/en/) that the
procedure be limited to the infant's first 60 days of life.

I believe what makes the most sense for choosing a technique is for a country or
region to decide which is the best method for themselves (for standardized
general scale-up); however, individual providers will also have to decide with
which method they are most comfortable (especially private practitioners).
Although all methods have pros and cons, some of the most important factors are
extrinsic to the device and those are supply chain management and disinfection
facilities. Cost will also have to be taken into consideration.

>From many perspectives the best time to circumcise is in the early infancy
period: as per the WHO recommendations in March 2007
(http://data.unaids.org/pub/Report/2007 ...

Dear Alliance,

Neonatal circumcision refers to the procedure done in neonates, that is
according to the medical definition of up to 28 days of life (first 4 weeks of
life).

Infancy is strictly defined as the first year of life, and WHO advocates for the
procedure in EARLY infancy. WHO is currently recommending in their Manual for
Early Infant Male Circumcision Under Local Anesthesia
(http://www.who.int/hiv/pub/malecircumcision/manual_infant/en/) that the
procedure be limited to the infant's first 60 days of life.

I believe what makes the most sense for choosing a technique is for a country or
region to decide which is the best method for themselves (for standardized
general scale-up); however, individual providers will also have to decide with
which method they are most comfortable (especially private practitioners).
Although all methods have pros and cons, some of the most important factors are
extrinsic to the device and those are supply chain management and disinfection
facilities. Cost will also have to be taken into consideration.

>From many perspectives the best time to circumcise is in the early infancy
period: as per the WHO recommendations in March 2007
(http://data.unaids.org/pub/Report/2007/mc_recommendations_en.pdf) this is when
the procedure is less complicated and less risky.

I don't have experience with adhesives for wound management but look forward to
comments from others.

Sincerely,

Rebeca Plank
--------------------------------------------------------------
Rebeca M. Plank, MD
Division of Infectious Diseases
Brigham and Women's Hospital
15 Francis Street PBB-A-4
Boston, MA 02115