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| Name | Class |
|---|---|
| University of Washington | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| circumcision with simple circumcision device | Procedure | Circumcision performed with the device in the operating room using local anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time of circumcision | To determine how long the operative procedure required to complete | 1 day |
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| Name | Affiliation | Role |
|---|---|---|
| John N Krieger, MD | University of Washington/Seattle Puget Sound VA Health Care System | Principal Investigator |
| James M Hotaling, MD MS | University of Washington | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Administration Puget Sound Health Care System | Seattle | Washington | 98108 | United States |
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| ID | Term |
|---|---|
| D002944 | Circumcision, Male |
| ID | Term |
|---|---|
| D046289 | Body Modification, Non-Therapeutic |
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |