Wikipedia

Circumcision surgical procedure

(Redirected from Gomco clamp)

Circumcision surgical procedure in males involves either a conventional "cut and stitch" surgical procedure or use of a circumcision instrument or device. In the newborn period (less than 2 months of age), almost all circumcisions are done by generalist practitioners using one of three surgical instruments. In the US, the Gomco clamp is the most utilized instrument, followed by the Mogen clamp and the Plastibell.[1] They are also used worldwide.[2]

Circumcision surgical procedure
Circumcision surgery with hemostats and scissors
ICD-10-PCSZ41.2
ICD-9-CMV50.2
MeSHD002944
MedlinePlus002998
eMedicine1015820

Complications may include bleeding, infection, reduction in sensation of the glans penis,[3] and too little or too much tissue removal.[4] Deaths are rare.[5][4] After the newborn period, circumcision has a higher risk of complications, especially bleeding and anesthetic complications.[6]

In the 21st century, most circumcisions in boys and men are performed using one of three open surgical methods. The forceps-guided method, the dorsal slit method, and the sleeve resection method are well described by the World Health Organization in their Manual for Male Circumcision under Local Anaesthesia.[7] The Gomco clamp and Mogen clamp are sometimes used after the newborn period, in conjunction with either surgical sutures or cyanoacrylate tissue adhesive to prevent post-operative bleeding.[8]

Circumcision surgical instruments should be distinguished from circumcision devices. Circumcision instruments are used at the time of surgery, and the circumcision is complete at the end of the procedure. The Gomco clamp, the Mogen clamp, and Unicirc are surgical instruments.[9] Circumcision devices remain on the penis for 4 to 7 days and either spontaneously detach or are removed surgically at a subsequent visit.[10] Plastibell, Shang Ring, and other plastic rings are all circumcision devices, also known as "in situ" devices.[9] Circumcision via instrument results in healing by primary intention and healing via devices is by secondary intention, so healing is delayed. All circumcision procedures should involve adequate injectable or topical anesthesia.[6]

Circumcision surgical instruments

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Gomco clamp

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An adult man being circumcised with a Gomco clamp

The Gomco clamp is a surgical instrument used to perform circumcision in all age groups, but is mainly used in newborn circumcision.[11] It is the leading instrument for newborn circumcision in the US.[1] The World Health Organization describes it as having "an impeccable safety record".[2]

After retracting the foreskin, the Gomco bell is placed over the glans at the level of the corona and the foreskin is replaced into the anatomic (natural) position. The yoke is then placed over the bell, trapping the foreskin between the bell and the yoke. The clamp is tightened, crushing the foreskin between the bell and the base plate, and left in place for five minutes. The crushed blood vessels provide hemostasis. The flared bottom of the bell fits tightly against the hole of the base plate, so the foreskin may be cut away with a scalpel from above the base plate, the intent being a lower risk of injuring the glans.

Advantages

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Circumcision is rapid and completed in a single session. The total procedure takes less than ten minutes, five minutes of which is spent in waiting for the crushing action to take place. In newborns (<2 months of age), no sutures are needed and bleeding is uncommon.[6] After the newborn period, either sutures or cyanoacrylate tissue adhesive can be used to seal the fused mucosal-skin edge to prevent post-operative bleeding.[8] Because the glans is protected by the bell of the Gomco clamp, injuries to the glans are rare. No parts are left on the penis, so late complications are rare compared to devices like the Plastibell which remain on the penis.[2]

Complications

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Care must be taken to ensure that the device is properly sterilized between procedures, or transmission of infection may occur. The American Academy of Pediatrics reviewed one study of 1,000 newborn Gomco circumcisions in a hospital setting in Saudi Arabia and rated it "fair evidence". The study found an overall complication rate of 1.9%. Bleeding occurred in 0.6% of cases, infection in 0.4%, and insufficient foreskin removed in 0.3%.[6]

Because the Gomco clamp is made of three major parts, there is a chance that pieces could be incorrectly assembled from differently sized units or those produced by different manufacturers. Using mismatched parts results in a device that might not sufficiently crush the foreskin, potentially resulting in bleeding.[2]

History

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The Gomco clamp was invented by Dr. Hiram S. Yellen and Aaron A. Goldstein in 1935. Yellen, an obstetrician-gynecologist in Buffalo, New York, sought an improved method of newborn circumcision. Goldstein was a prolific local inventor and manufacturer.[11] Gomco stands for the GOldstein Medical COmpany, the original manufacturer of the instrument.[11] The patent was in the name of Aaron Goldstein (U.S. patent 119,180, issued February 27, 1940).[11] The instrument was a quick success and was widely marketed and sold in the US and Canada. It has since been manufactured and marketed worldwide.[11]

Prevalence

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The Gomco clamp is the leading instrument used to perform non-ritual male circumcision in the United States.[2] There is little information concerning prevalence of Gomco use outside of the US. A 1998 survey found that the Gomco clamp was the technique preferred by 67% of American physicians, whereas Plastibell was used by 19% and the Mogen clamp by 10%.[1]

Mogen clamp

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The Mogen clamp is a surgical instrument which permits rapid circumcision. It is most often used in the newborn period, particularly for Jewish ceremonial circumcision (Bris), but is also used in older boys. The newborn version has two flat blades that open 2.5 mm.[2] The Mogen clamp is widely used around the world.[2]

The foreskin is first extended using several straight hemostats. The Mogen clamp is then slid over the foreskin. After confirming that the tip of the glans is free of the blades, the clamp is locked, and a scalpel is used to cut the skin from the flat (upper) side of the clamp. In newborns, no sutures are required. Outside of the newborn period, cyanoacrylate tissue adhesive can be used instead of sutures.[8]

Advantages

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The Mogen clamp has no parts to assemble, is easy to use, and results in a bloodless circumcision with minimal scarring. A single size can be used for infants, obviating any sizing errors. It is rapid, but requires five minutes of clamping to prevent post-operative bleeding. Any complications are immediate, because the instrument is not left on the penis, so they can be dealt with on site.[2] The clamp can be safely used by non-physician healthcare workers in resource-limited settings.[12][13][14]

Complications

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Care must be taken to ensure that the device is properly sterilized between procedures, or transmission of infection may occur. The instrument does not directly protect the glans during the procedure, so there is a risk that the glans can be pulled into the slit and crushed or partially severed.[2]

In July 2010, one company manufacturing Mogen clamps (Mogen Circumcision Instruments of New York) went out of business following a lawsuit in which the doctor entirely removed the head of the penis from the child. The court awarded the plaintiff $10 million in damages.[15] This came following similar lawsuits in 2007 and 2009, which awarded $7.5 million and $2.3 million, respectively. According to the American Academy of Pediatrics, there are no good studies of complications of the Mogen clamp because complications are rare; thus, one can only rely on available case reports of glans injuries.[6]

History

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The word mogen is derived from the Hebrew word for "shield". The Mogen clamp was introduced by Dr. Harry Bronstein in 1955.[2] Before the advent of the Mogen clamp, the Jewish shield was used, which has a narrow gap that protected the glans while the foreskin was pulled through and excised. Others modified this shield and began using instruments that produced a crushing action. Still used in many parts of the world, bone cutters are used to shield the glans, crush the foreskin tissue and guide the scalpel for a clean incision. The Mogen clamp is a refinement of these ancient techniques.[2]

Other instruments

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The Winkelmann clamp is a sterilizable Gomco-like instrument which consists of a single unit, so mismatching of parts cannot occur. Unicirc is a disposable plastic and metal instrument which functions similarly to the Gomco clamp, and, according to WHO, has "nearly met the clinical evaluation study requirements described in the WHO Framework for the Clinical Evaluation of Devices."[16]

Research

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A meta-analysis of randomized controlled trials suggested that compressive instruments were associated with less blood loss, more rapid healing, and less pain compared to other techniques.[17]

Circumcision "in situ" devices

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All "in situ" devices are based upon steel circumcision rings patented by Cecil Ross in 1939.[2] Plastibell represents the first commercialization of the Ross device and is the progenitor of all subsequent "in situ" devices. Such devices consist of a plastic ring which is inserted beneath the foreskin at the level of the corona and has a ligature, or ligature device, which acts as a tourniquet. This necroses the remaining part of the foreskin and the device either detaches spontaneously after 4 to 7 days, or is removed surgically at one week. Implementation of "in situ" devices for HIV prevention has failed to demonstrate potential advantages with regard to efficiency or cost, compared to conventional surgical circumcision.[10]

Plastibell

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The Plastibell plastic ring is placed under the foreskin and secured with a circumferential ligature, which prevents bleeding when the distal foreskin is excised. The entire procedure takes five to ten minutes.[18] The ring falls off after 4 to 7 days, leaving a circumferential wound that heals by secondary intention in one to two weeks.

Advantages

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Plastibell is a single-use-only disposable device, which prevents reuse and potential transmission of infection. The glans is protected during the procedure by the ring, so there is a reduced risk of injury to the glans, compared to the Mogen clamp.[2] It is a rapid procedure which can be done under clean (rather than sterile) conditions. No bandage is required, allowing for easy monitoring for bleeding or infection.

Complications

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The American Academy of Pediatrics estimates that overall complications occur in 2.4–5% of Plastibell procedures.[6] The risk of bleeding is 1%, similar to the risk with the Gomco clamp and Mogen clamp.[2] A significant complication can occur if the glans swells and herniates (protrudes) through the ring. This worsens the swelling and can reduce blood and urine flow, resulting in serious long-term sequelae. Unlike complications occurring with surgical instruments that are dealt with immediately, this complication occurs hours to days after the patient leaves the clinic and must be dealt with promptly to prevent serious complications. Therefore, Plastibell should only be used when follow-up is rapidly available.[2]

History

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The idea of using a tourniquet approach to infant circumcision is attributed to Cecil J. Ross, who patented steel circumcision rings in 1939.[2] Subsequently, Kariher patented a plastic ring with a removable handle in 1955.[2] The Plastibell comes in a sterile package with a single ligature.

Shang ring

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The Shang Ring is a disposable plastic "in situ" device for male circumcision. It has been studied in China and Africa, and has been approved by WHO for circumcision in males over 13 years of age to prevent HIV. The Shang Ring consists of two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring that acts as a ligature. The appropriate size is determined through use of a measuring strip. The inner ring is placed underneath the foreskin. The outer (hinged) ring is placed on the outside of the foreskin and locks against the inner ring when snapped together. The distal foreskin is then excised. The Shang Ring is removed after one week when the outer ring locking mechanism is opened using a special tool. A pair of scissors designed for this purpose is then used to remove the inner ring.[19]

Advantages

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Shang Ring is marketed as simple, disposable, easy to use, and provides sutureless circumcision that may be an acceptable alternative to conventional surgical techniques.[20]

Complications

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Like other "in situ" devices, complications may occur up to several days following the placement procedure and must be dealt with promptly to prevent serious sequelae. Shang Ring should only be used where surgical care is rapidly available. In a review by WHO personnel, 0.4% men required rapid intervention with surgical circumcision as the excision had occurred but the foreskin slipped from the device and required suturing. No serious adverse events occurred; 1% experienced moderate adverse events from a total of 1983 successful device placements. All adverse events were managed with minor interventions and resolved without long-term sequelae. Rates were similar to those observed with conventional surgical circumcision.[21]

In settings where skilled surgeons are mostly located in urban centers, referral of clients who require surgical management of device-related complications within the recommended time frame of 6–12 hours may not be possible.[10] Healing is by secondary intention and is therefore delayed compared to techniques which allow for healing by primary intention. There is a risk of HIV transmission if men engage in unprotected sex before the wound is healed. Thus, Shang Ring circumcision requires a longer period of post-circumcision sexual abstinence than surgical or instrumental methods.[19]

History

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The Shang Ring was developed by Jianzhong Shang in 2003.[19] The Shang Ring has been approved by WHO,[19] and is cleared by the U.S. FDA under the 510(k) mechanism with Plastibell as the predicate device.[22]

References

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  1. ^ a b c Stang HJ, Snellman LW (June 1998). "Circumcision practice patterns in the United States". Pediatrics. 101 (6): E5. doi:10.1542/peds.101.6.e5. PMID 9606247.
  2. ^ a b c d e f g h i j k l m n o p q Manual for early infant male circumcision under local anaesthesia. Geneva: World Health Organization. 2010. Archived from the original on August 12, 2011.
  3. ^ "Circumcision in men". nhs.uk. October 18, 2017.
  4. ^ a b Krill AJ, Palmer LS, Palmer JS (2011). "Complications of circumcision". TheScientificWorldJournal. 11: 2458–68. doi:10.1100/2011/373829. PMC 3253617. PMID 22235177.
  5. ^ Williams N, Kapila L (October 1993). "Complications of circumcision". The British Journal of Surgery. 80 (10): 1231–6. doi:10.1002/bjs.1800801005. PMID 8242285. S2CID 27220497.
  6. ^ a b c d e f American Academy of Pediatrics Task Force on Circumcision (September 2012). "Male circumcision". Pediatrics. 130 (3): e756-85. doi:10.1542/peds.2012-1990. PMID 22926175.
  7. ^ "Manual for male circumcision under local anaesthesia". Geneva: World Health Organization. December 2009. Archived from the original on March 28, 2009.
  8. ^ a b c Lane V, Vajda P, Subramaniam R (February 2010). "Paediatric sutureless circumcision: a systematic literature review". Pediatric Surgery International. 26 (2): 141–4. doi:10.1007/s00383-009-2475-y. PMID 19707772. S2CID 27495715.
  9. ^ a b Framework for Clinical Evaluation of Devices for Adult Male Circumcision (PDF) (Report). WHO. 2007. Archived from the original (PDF) on 2011-11-14. Retrieved 2017-04-18.
  10. ^ a b c Ridzon R, Reed JB, Sgaier SK, Hankins C (June 2016). "VMMC Devices-Introducing a New Innovation to a Public Health Intervention". Journal of Acquired Immune Deficiency Syndromes. 72 (Suppl 1): S1-4. doi:10.1097/QAI.0000000000000967. PMC 4936419. PMID 27331583.
  11. ^ a b c d e Wan J (May 2002). "GOMCO circumcision clamp; an enduring and unexpected success". Urology. 59 (5): 790–4. doi:10.1016/s0090-4295(01)01320-6. PMID 11992930.
  12. ^ Kankaka, Edward N.; Murungi, Teddy; Kigozi, Godfrey; Makumbi, Frederick; Nabukalu, Dorean; Watya, Stephen; Kighoma, Nehemiah; Nampijja, Resty; Kayiwa, Daniel; Nalugoda, Fred; Serwadda, David; Wawer, Maria; Gray, Ronald H. (January 2017). "Randomised trial of early infant circumcision performed by clinical officers and registered nurse midwives using the Mogen clamp in Rakai, Uganda". BJU International. 119 (1): 164–170. doi:10.1111/bju.13589. PMID 27597563. S2CID 9621799.
  13. ^ Fowler GC, Pfenninger JL (2003). Pfenninger and Fowler's procedures for primary care. St. Louis: Mosby. ISBN 978-0-323-00506-7.[page needed]
  14. ^ Reynolds RD (July 1996). "Use of the Mogen clamp for neonatal circumcision". American Family Physician. 54 (1): 177–82. PMID 8677833.
  15. ^ Tagami T. "Atlanta lawyer wins $11 million lawsuit for family in botched circumcision". The Atlanta Journal-Constitution. Retrieved 2017-05-24.
  16. ^ Preventing HIV Through Safe Voluntary Medical Male Circumcision for Adolescent Boys and Men in Generalized HIV Epidemics: Recommendations and Key Considerations. World Health Organization. 2020. ISBN 978-92-4-000854-0. NBK562463.
  17. ^ Fan Y, Cao D, Wei Q, Tang Z, Tan P, Yang L, et al. (May 2016). "The characteristics of circular disposable devices and in situ devices for optimizing male circumcision: a network meta-analysis". Scientific Reports. 6: 25514. Bibcode:2016NatSR...625514F. doi:10.1038/srep25514. PMC 4860598. PMID 27156368.
  18. ^ Barrie H, Huntingford PJ, Gough MH (July 1965). "The Plastibell Technique for Circumcison". British Medical Journal. 2 (5456): 273–5. doi:10.1136/bmj.2.5456.273. PMC 1845746. PMID 14310205.
  19. ^ a b c d Male circumcision for HIV prevention : WHO technical advisory group on innovations in male circumcision : evaluation of two adult devices, January 2013 : meeting report. World Health Organization. 2013. hdl:10665/85269. ISBN 978-92-4-150563-5.[page needed]
  20. ^ Cao D, Liu L, Hu Y, Wang J, Yuan J, Dong Q, Wei Q (April 2015). "A systematic review and meta-analysis of circumcision with Shang Ring vs conventional circumcision". Urology. 85 (4): 799–804. doi:10.1016/j.urology.2014.12.007. PMID 25711156.
  21. ^ Samuelson J, Baggaley R, Hirnschall G (October 2013). "Innovative device methods for adult medical male circumcision for HIV prevention: lessons from research". Journal of Acquired Immune Deficiency Syndromes. 64 (2): 127–9. doi:10.1097/QAI.0b013e3182a61dd3. PMID 23892240.
  22. ^ 510(k) -Summary for the Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. ShangRing (PDF) (Report). 2012.

Further reading

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