Tag Archives: Trihealth Good Samaritan

mogen_and_gomco

Call to Action: Clinical trial of Mogen vs Gomco circumcision clamps at the Good Samaritan Hospital in Cincinnati, Ohio

The TriHealth Good Samaritan Hospital in Cincinnati, Ohio, is currently running a clinical trial to find which is better, whether the mogen clamp or the gomco clamp, to perform newborn male circumcisions.

Bottom-left: Mogen clamp. Top-right: Gomco clamp

The purpose of this study is to compare two commonly used circumcision clamps (Gomco and Mogen) to see which results in less neonatal pain. Neonatal pain will be assessed by change in salivary cortisol level pre and post procedure. Secondary to that they will study which one causes more bleeding, requires more time, which one is followed by most parental satisfaction (what about the satisfaction of the adult that the baby will become?) on a follow up visit, which one causes more need for revisions (including recircumcisions) within 6 weeks, and which one is more likely to cause infections.

Bleeding is measured by weight of blood soaked gauzes after the procedure.

Mogen Clamp
Gomco Clamp

Other outcome measures include neonatal pain score and a standarized score including vital signs and facial expression.

Evolution of the facial expressions of a baby during circumcision

They are starting from the hypothesis that the Mogen technique of circumcision is less painful, faster, and associated with less bleeding for newborns when compared to the Gomco technique after a resident circumcision standard teaching curriculum.

The participants are euphemistically called “volunteers”, and they should be male babies 4 days or less, born healthy from pregnancies without complications.

Now, what could be wrong with this?

Let’s start with the obvious. They are not pretending that the procedure is painless. They know that the procedure hurts, and that’s what they want to compare.

The action of inflicting severe pain on someone is called torture. They are torturing babies. But then of course, every forced circumcision of a minor is torture.

Now, in order to do this they obtain consent from the parents. But parents are often unaware of how much pain a circumcision really causes until they see a video of the procedure. I would have to wonder how much information the parents obtain prior to consenting to the study.

In this video, you can hear the dad freaking out as the baby starts crying. The doctor says the baby is “excited”.

Calling the baby a “volunteer” is such a horrible stretch. With the Gomco clamp I’m very sure they have to use a circumstraint, a board with Velcro straps to hold the baby still while they perform the procedure. Volunteers normally don’t have to be forcefully restrained. In fact, I know of a lawsuit in the 1980s that successfully charged that the baby was falsely imprisoned  due to the use of restraints. Most health professionals are aware that forcefully restraining an adult has legal and ethical implications, but why is it that they don’t seem to have the same consideration to minors?

Baby strapped on a circumstraint
1984 NOCIRC newsletter detailing lawsuit including charges for battery and false imprisonment.

But not only do they know that the procedure is painful, they are also aware that there are risks and complications, and they DO expect to see those risks (infections and bleeding being the most common) and complications (including adhesions although they didn’t mention them, and the need to repairs and recircumcisions). In other words, they are running a medical experiment on human babies, knowing that those babies are going to suffer pain and that some are going to need additional surgeries or may suffer even more severe complications.

Skin bridge (adhesion) on a circumcised penis, a common complication that can cause pain during sex

Now, the real messed part is that they are using the mogen clamp. It sounds innocent enough, the more common methods used on newborns are the plastibell, the gomco clamp and then the mogen clamp (which is favored by Jewish mohelin but not so much by the medical community). So what can be wrong with assessing which one is best?

Well, for one, the mogen clamp is far from having a clean record. The “Manual for early infant male circumcision under local anaesthesia” published by the World Health organization in 2010 details that both the mogen clamp and the gomco clamp have an increased risk for penile laceration and amputation, but extends to say that “penile amputation can occur even under ideal circumstances” with the mogen clamp.

http://apps.who.int/iris/bitstream/10665/44478/1/9789241500753_eng.pdf

Now, has this ever happened? Yes, it happened in Israel in June of 2012 to a Muslim baby. It also happened in Illinois in February of 2007 in a medical circumcision, and also in Florida in 2004 in a Jewish circumcision (the mohel, Daniel Krimsky, tried to conceal the error causing loss of time and damage to the tissue, which failed to reattach). The same year it also happened to a baby circumcised by doctor Haiba Sonyika, who also failed to react timely, resulting in significant injury and iatrogenic hypospadias (in other words, the baby urinates through a new hole misplaced because of surgical mishap) and will require counseling and surgeries along his life. And it also happened in 2003 in L.A.

In 2004, Dan Savage, known columnist, received a letter from a man who suffered exactly this kind of injury:

I am 24 years old and lost my entire glans penis, the head of my dick, in a botched circumcision. Basically I have a shaft but there’s no head at the end. Unfortunately, I was left with my balls so I still have a sex drive, but it’s nearly impossible for me to climax. When I was much younger, around 14 to 16, I could sometimes masturbate to a climax, but after a couple of years I stopped being able to do this. Some of the women I’ve been with never saw the condition of my penis, and failed to notice when I didn’t come. Others have seen my condition before intercourse and refused to have sex with me, while still others found out afterwards, after I wasn’t able to come, and then never wanted to have sex with me again. Of course I never dare to ask anyone to suck me, although this might provide the necessary extra stimulation and actually help me climax.

So my problem, Dan, is twofold: I can’t come and I can’t get anyone to stick around and help me try to come. Can you suggest any special techniques for someone in my condition? Any help would be appreciated. I’m very miserable, frustrated, and lonely.

Mutilated and Comeless

Partial glans amputation, a complication of the Mogen clamp – photo from circumcisionharm.org

Glans laceration caused by clamp – photo from circumcisionharm.org

http://www.circleaks.org/index.php?title=Documented_Severe_Complications_of_Circumcision

In fact, these cases have been so common and so catastrophic that Mogen Circumcision Instruments Company went out of business in 2010 after paying several millionaire lawsuits. The clamps however were not recalled.

http://www.circleaks.org/index.php?title=Mogen

http://www.jacksonwhitelaw.com/az-personal-injury/2012/03/21/the-controversy-behind-the-mogen-clamp/

Not only were the clamps not recalled, but they are still in use, being favored by the often mentioned Dr. Neil Pollock in Canada (also a mohel), and recently received favorable reviews in a 2012 paper about the safety of over 1,200 infant male circumcisions in Kenya (in which there was one adverse event involving partial amputation of the glans)

Young, MR, Bailey RC, Odoyo-June E. Irwin TE, Obiero W, et al (2012). Safety of over twelve hundred infant male circumcisions using the Mogen clamp in Kenya. PLoS ONE 7(10): e47395, doi: 10.1371/journal.pone.0047395
http://www.readcube.com/articles/10.1371/journal.pone.0047395

In a 2013 study by Rebecca Plank in Botswana, the mogen clamp and the plastibell were compared. The adverse events with the mogen clamp were considered to be more frequent but “minor” (removal of too little skin and development of skin bridges and adhesions). Bleeding was more frequent with the mogen clamp as well.

Plank RM et al. A randomized trial of Mogen clamp versus Plastibell for neonatal circumcision in Botswana. J Acquir Immune Defic Syndr, online edition, DOI: 10.1097/QAI.0b013e318285d449, 2013.
http://www.aidsmap.com/Neonatal-male-circumcision-feasible-in-resource-limited-settings-Mogen-clamp-may-have-advantages/page/2566263/

Data from Attorneys for the Rights of the Child, ARCLaw, show over 80 million dollars paid on settlements over botched circumcisions since 1985. Beyond the economic value (when compared to a billion dollars a year industry), those numbers represent children whose lives were impacted for ever due to an elective surgery.

So, what the big picture tells us is that what these researchers at TriHealth Good Samaritan Hospital in Cincinnati, Ohio, are doing, is an experiment on human, American babies, which knowingly causes pain, without any existing condition or disease removes normal healthy and functional erogenous tissue from non-consenting “volunteers” (with no regard for the future preference of the adults they will become), subjects healthy individuals to amputative surgery, and risks causing iatrogenic harm to those babies, practicing a XIX century “elective” surgery (which again, they did not elect) with obsolete and dangerous equipment.

Mechanical function of the foreskin during sexual activity – a pleasure denied to circumcised men
Comparison of an intact penis with its frenulum, and a circumcised penis missing the frenulum and with keratinized glans

Personally, it bothers me that the 3 listed researchers are females. I wonder if I’m the only one who sees something wrong in 3 female researchers looking for the best way to slice and skin babies penises. In a way they are doing to babies almost the same thing that Lorena Bobbitt did to her husband, except that they are doing it protected under medical license and with the subterfuge of research.

I’m reminded of a 1959 American researcher, W. G. Rathmann MD, who invented a clamp for female circumcision, as a cure for frigidity. At least he wasn’t targeting infants.

Rathmann Clamp for female circumcision
Rathmann clamp in action – clamping the clitoral hood, the female equivalent of the male foreskin

Promoters of female circumcision were in the wrong side of history, and so are promoters and researchers of infant male circumcision. The fact that it is an unnecessary operation, that it has risks and causes pain, that it provokes sexual changes, and that it is performed on a healthy normal baby who does not have a disease or condition, should be reason enough to stop right now.

Perhaps it is time they run a clinical trial to compare the pain and risk of complications between circumcised babies and “uncircumcised” babies (intact babies). I dare you AAP.

[I]t can no longer confidently assume that circumcising a healthy boy will be viewed by him later as beneficial. Increasingly, circumcised males are learning the functions of intact genitals, documenting the harm from circumcision and pursuing genital wholeness. They will undoubtedly increase their pressure on circumcising societies to affirm male genital integrity and to prevent involuntary nontherapeutic circumcision.“ 

Hammond, T. (1999), A preliminary poll of men circumcised in infancy or childhood. BJU International, 83: 85–92. doi: 10.1046/j.1464-410x.1999.0830s1085.x
http://www.noharmm.org/bju.htm

Information on the trial:

http://apps.who.int/trialsearch/trial.aspx?TrialID=NCT01726036

http://clinicaltrials.gov/show/NCT01726036

Principal Investigator: Mounira Habli, MD
http://www.cincinnatichildrens.org/bio/h/mounira-habli/        
mounira_habli@trihealth.com

Contact: Michaela Eschenbacher, MPH
http://www.linkedin.com/in/michaelaeschenbacher   
michaela_eschenbacher@trihealth.com  

Contact: Rachel Sinkey, MD
http://www.trihealth.com/discover-trihealth/education/trihealth-obstetrics-and-gynecology-residency/list-of-current-residents/      
rachel_sinkey@trihealth.com

Sponsors and Collaborators
TriHealth Inc.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726036

A list of ongoing clinical trials on circumcision: http://www.nhs.uk/Conditions/Circumcision/Pages/clinical-trial.aspx

Van and Benjamin Lewis, 1970, Tallahassee Florida

PS, while we are at it, this page: http://www.cincinnatichildrens.org/health/m/male-anatomy/ states that “Other boys are not circumcised and may have skin that covers the tip of the penis. If circumcision is not done the skin must be pulled back for proper cleaning” — The problem with this is that it does not specify any age. The foreskin at birth is sealed to the glans, and it CANNOT be retracted. Retracting the foreskin of a child who has not yet separated can result in pain, bleeding, infection and development of adhesions. In turn, this can result in scar tissue that will become acquired phimosis and MAY require circumcision. See how bad this advice is?

Please let these guys know that they need to be clear. Nobody needs to retract a child’s foreskin. Cleaning inside the foreskin can wait until the child becomes retractable (which may take until puberty – 17 years is not an uncommon age to become retractable) and should only be done by the child himself, not by the parents. It is not advisable to use soap in cleaning inside the foreskin as this can cause irritations and infections. Retract, rinse and replace, that’s all it takes to wash the penis of a male who can already retract.

It is fair to acknowledge that on this other page: http://www.cincinnatichildrens.org/health/u/uncircumcised/ they provide better advice regarding age of retraction. But they still recommend soap, and this is a common reason why many “uncircumcised” males complain of irritation and infection. Soap disrupts the delicate pH and bacterial environment of the foreskin and may cause irritations. Soap, if used, should be mild, unscented, and rinsed completely. Better yet, just use warm water.