High rate of adverse events following circumcision of young male adults with the Tara KLamp technique: A randomised trial in South Africa
Abstract
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 selfestimated 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.
Copyright remains in the Author’s name. The work is licensed under a Creative Commons Attribution - Noncommercial Works License. Authors are required to complete and sign an Author Agreement form that outlines Author and Publisher rights and terms of publication. The Agreement form should be uploaded along with other submissions files and any submission will be considered incomplete without it [forthcoming].
Material submitted for publication in the SAMJ is accepted provided it has not been published or submitted for publication elsewhere. Please inform the editorial team if the main findings of your paper have been presented at a conference and published in abstract form, to avoid copyright infringement. The SAMJ does not hold itself responsible for statements made by the authors.
Previously published images
If an image/figure has been previously published, permission to reproduce or alter it must be obtained by the authors from the original publisher and the figure legend must give full credit to the original source. This credit should be accompanied by a letter indicating that permission to reproduce the image has been granted to the author/s. This letter should be uploaded as a supplementary file during submission.
