High rate of adverse events following circumcision of young male adults with the Tara KLamp technique : A randomised trial in South Africa

The Tara KLamp (TK) device has been claimed to enable circumcisions to be performed safely and easily in medical and non-medical environments. Published evaluation studies have been conducted among young children only. Following a randomised controlled trial (RCT) on 3 274 participants on the impact...

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Published in:South African medical journal 2009-03, Vol.99 (3), p.163-169
Main Authors: LAGARDE, Emmanuel, TALJAARD, Dirk, PUREN, Adrian, AUVERT, Bertran
Format: Article
Language:English
Subjects:
Biological and medical sciences
Circumcision
Circumcision, Male - adverse effects
Complications and side effects
General aspects
Health aspects
HIV Infections - prevention & control
Human immunodeficiency virus
Humans
Linear Models
Male
Medical sciences
Men
Methods
Pain Measurement
South Africa
Surgical Instruments
Young Adult
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container_title South African medical journal
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creator LAGARDE, Emmanuel
TALJAARD, Dirk
PUREN, Adrian
AUVERT, Bertran
description The Tara KLamp (TK) device has been claimed to enable circumcisions to be performed safely and easily in medical and non-medical environments. Published evaluation studies have been conducted among young children only. Following a randomised controlled trial (RCT) on 3 274 participants on the impact of male circumcision on HIV transmission, 69 control group members participated in this male circumcision methods trial and were randomised to a forceps-guided (FG) group and a TK group, and circumcised. Of the 166 men asked to participate, 97 declined, most (94) refusing circumcision by the TK technique; 34 men were randomised to the FG group and 35 to the TK group, and 32 and 24 patients were circumcised by the FG and TK methods respectively, of whom 29 and 19 respectively attended the post-circumcision visit. All 12 adverse event sheets corresponded to the TK group (p
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Less favourable outcomes were associated with the TK method, including any sign of an adverse event (37% v. 3%; p=0.004), delayed wound healing (21% v. 3%; p=0.004) and problems with penis appearance (31% v. 3%; p=0.001). Participants randomised to the TK method were significantly more likely to report bleeding (21% v. 0%; p=0.02), injury to the penis (21% v. 0%; p=0.02), infection (32% v. 0%; p=0.002), swelling (83%/ v. 0%; p&lt;0.001), and problems with urinating (16% v. 0%; p=0.056). The mean score of self-estimated pain was 9.5 for participants circumcised by TK compared with 6.1 for other participants (adjusted p=0.003). 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Less favourable outcomes were associated with the TK method, including any sign of an adverse event (37% v. 3%; p=0.004), delayed wound healing (21% v. 3%; p=0.004) and problems with penis appearance (31% v. 3%; p=0.001). Participants randomised to the TK method were significantly more likely to report bleeding (21% v. 0%; p=0.02), injury to the penis (21% v. 0%; p=0.02), infection (32% v. 0%; p=0.002), swelling (83%/ v. 0%; p&lt;0.001), and problems with urinating (16% v. 0%; p=0.056). The mean score of self-estimated pain was 9.5 for participants circumcised by TK compared with 6.1 for other participants (adjusted p=0.003). 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Published evaluation studies have been conducted among young children only. Following a randomised controlled trial (RCT) on 3 274 participants on the impact of male circumcision on HIV transmission, 69 control group members participated in this male circumcision methods trial and were randomised to a forceps-guided (FG) group and a TK group, and circumcised. Of the 166 men asked to participate, 97 declined, most (94) refusing circumcision by the TK technique; 34 men were randomised to the FG group and 35 to the TK group, and 32 and 24 patients were circumcised by the FG and TK methods respectively, of whom 29 and 19 respectively attended the post-circumcision visit. All 12 adverse event sheets corresponded to the TK group (p&lt;0.001) and circumcisions by the TK method. Less favourable outcomes were associated with the TK method, including any sign of an adverse event (37% v. 3%; p=0.004), delayed wound healing (21% v. 3%; p=0.004) and problems with penis appearance (31% v. 3%; p=0.001). Participants randomised to the TK method were significantly more likely to report bleeding (21% v. 0%; p=0.02), injury to the penis (21% v. 0%; p=0.02), infection (32% v. 0%; p=0.002), swelling (83%/ v. 0%; p&lt;0.001), and problems with urinating (16% v. 0%; p=0.056). The mean score of self-estimated pain was 9.5 for participants circumcised by TK compared with 6.1 for other participants (adjusted p=0.003). This study provides compelling evidence that strongly cautions against use of the TK method on young adults.</abstract><cop>Rondebosch</cop><pub>Health and Medical Publishing Group</pub><pmid>19563093</pmid><tpages>7</tpages><oa>free_for_read</oa></addata></record>
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source Directory of Open Access Journals
subjects Biological and medical sciences
Circumcision
Circumcision, Male - adverse effects
Complications and side effects
General aspects
Health aspects
HIV Infections - prevention & control
Human immunodeficiency virus
Humans
Linear Models
Male
Medical sciences
Men
Methods
Pain Measurement
South Africa
Surgical Instruments
Young Adult
title High rate of adverse events following circumcision of young male adults with the Tara KLamp technique : A randomised trial in South Africa
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