Simple circumcision device Proof of concept for a single visit adjustable device to facilitate safe adult male circumcision

Capsule:
A pilot trial of a novel circumcision device to facilitate safe, single-visit surgical circumcision in five patients from the Veterans Administration Puget Sound Healthcare System.

Authors:
James Morris Hotaling, M.D., M.S., Laura S. Leddy, M.D., Maahum A. Haider, M.D., Matthew Mossanen, M.D., Michael R. Bailey, Ph.D., Francis Olson, B.S., Brian MacConaghy, M.S., John N. Krieger, M.D.

Volume 101, Issue 5, Pages 1266–1270

Abstract:

Objective:
To conduct a proof-of-concept study to determine the potential utility of a novel, adjustable single-visit, disposable device to facilitate rapid adult circumcision.

Design:
Prospective pilot trial of a novel surgical device.

Setting:
Tertiary care Veterans Administration medical center.

Patient(s):
Five adult males.

Intervention(s):
Circumcisions performed by junior trainees using an adjustable, single-size surgical-assist device constructed by the University of Washington Applied Physics Laboratory.

Main Outcome Measure(s):
The attending surgeon and trainees completed standardized forms after each procedure to assess technical problems and ease of use. Follow-up visits were scheduled to evaluate adverse events, postoperative pain, cosmetic outcomes, and participant satisfaction at 3, 8, 30, and 90 days postoperatively.

Result(s):
The average operative time was 16.4 minutes. All cases were performed with local anesthesia, and no case required electrocautery or conversion to standard surgery. At the postoperative day 3 visit, all subjects were happy with their results and would recommend the procedure to another patient. One participant had a minor wound separation noted at the 30-day visit that resolved during follow-up. There were no wound infections, hematomas, or other adverse events.

Conclusion(s):
This proof-of-study suggests that the Simple Circumcision Device may facilitate delivery of safe adult male circumcision services.

  • Carlos Balmori

    Thanks to the authors for the development of this new device that will
    facilitate our work. I think that the main problem is the single-size. The width
    of the adjustable outer ring would not allow us to use in buried penis, micropenis
    or children’s. A solution would be to make this piece thinner. The glans cap
    can have the same problem.

  • Similar to Dr Ko’s comment, this device serves as the adult version of the Gomco clamp. it appears that the key to success is proper penile block/local anesthesia to enable the procedure to be performed in the clinic setting. although feasible, it’ll be interesting to see patient satisfaction and tolerability in non-VA settings.

  • As surgeons, we constantly strive to improve our surgical techniques and instrumentation for simple procedures so that they can be performed with minimal morbidity and can be reproduced easily by others.
    This novel simple circumcision device seems to be a modification on the Gomco Clamp that used widely by many physicians in the Pediatric population, that can be used for adults. By standardizing the variables that usually are pitfalls for beginner physicians performing circumcisions. Although this is a small study with N=5, it does demonstrate proof of concept of a potentially easy means to circumcise men in the clinic or overseas with local anesthetic and minimal cost. However, this procedure may be even more cost effective without the use of Dermabond. It will be interesting to see future studies with more subjects.

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