BACKGROUND: 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. METHODS: 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. RESULTS: 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<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<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). CONCLUSION: This study provides compelling evidence that strongly cautions against use of the TK method on young adults.
RCT Entities:
BACKGROUND: 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. METHODS: 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. RESULTS: 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<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<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). CONCLUSION: This study provides compelling evidence that strongly cautions against use of the TK method on young adults.
Authors: James M Hotaling; Laura S Leddy; Mahum A Haider; Matthew Mossanen; Michael R Bailey; Brian MacConaghy; Francis Olson; John N Krieger Journal: Fertil Steril Date: 2014-03-06 Impact factor: 7.329
Authors: Richard G Wamai; Brian J Morris; Stefan A Bailis; David Sokal; Jeffrey D Klausner; Ross Appleton; Nelson Sewankambo; David A Cooper; John Bongaarts; Guy de Bruyn; Alex D Wodak; Joya Banerjee Journal: J Int AIDS Soc Date: 2011-10-20 Impact factor: 5.396