The investigators are testing a novel surgical device to facilitate safe circumcision among adult males. The investigators hypothesize that this device will allow non-medical providers to perform safe surgical circumcision without adverse events.
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 Patients: 5 adult males Interventions: 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, post-operative pain, cosmetic outcomes and participant satisfaction at 3, 8, 30 and 90 days post-operatively.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Circumcision performed with the device in the operating room using local anesthesia
Veterans Administration Puget Sound Health Care System
Seattle, Washington, United States
Efficacy, injury rate, conversion to standard method rate and cosmetic outcomes of novel surgical device
To determine if the novel surgical device was able to facilitate safe circumcision among adult males. Specifically we looked at: time of surgery, blood loss, ease of use, cosmetic outcome, number of sutures required, need for conversion to another method of circumcision and need for revision surgeries.
Time frame: 90 days
Time of circumcision
To determine how long the operative procedure required to complete
Time frame: 1 day
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