Document Detail


High rate of adverse events following circumcision of young male adults with the Tara KLamp technique: a randomised trial in South Africa.
MedLine Citation:
PMID:  19563093     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Emmanuel Lagarde; Dirk Taljaard; Adrian Puren; Bertran Auvert
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde     Volume:  99     ISSN:  0256-9574     ISO Abbreviation:  S. Afr. Med. J.     Publication Date:  2009 Mar 
Date Detail:
Created Date:  2009-06-30     Completed Date:  2009-08-20     Revised Date:  2014-09-12    
Medline Journal Info:
Nlm Unique ID:  0404520     Medline TA:  S Afr Med J     Country:  South Africa    
Other Details:
Languages:  eng     Pagination:  163-9     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Circumcision, Male / adverse effects*
HIV Infections / prevention & control
Humans
Linear Models
Male
Pain Measurement
South Africa
Surgical Instruments*
Young Adult

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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