BACKGROUND:Voluntary medical male circumcision (VMMC) is a priority HIV preventive intervention. To facilitate male circumcision scale- up, the World Health Organization is actively seeking circumcision techniques that are quicker, easier, and safer than open surgical methods. OBJECTIVE: To compare conventional open surgical circumcision with suturing with a minimally invasive technique using the Gomco circumcision clamp plus tissue adhesive. METHODS: We conducted a non-blinded randomised controlled trial comprising 200 male volunteers >18 years of age, seen at the outpatient university teaching clinic of the Catholic University of Mozambique. We compared two interventions - open surgical circumcision with suturing v. Gomco instrument plus tissue adhesive. Our primary outcome was intraoperative time and our secondary outcomes included: ease of performance, post-operative pain, adverse events, time to healing, patient satisfaction and cosmetic result. RESULTS: The intraoperative time was less with the Gomco/tissue adhesive technique (mean 12.8 min v. 22.5 min; p<0.001). Adverse events were similar except that wound disruption was greater in the Gomco/tissue adhesive group, with no difference in wound healing at 4 weeks. Levels of satisfaction were high in both groups. The cosmetic result was superior in the Gomco/tissue adhesive group. CONCLUSIONS: This study has important implications for the scale-up of VMMC services. Removing the foreskin with the Gomco instrument and sealing the wound with cyanoacrylate tissue adhesive in adults is quicker, is an easier technique to learn, and is potentially safer than open surgical VMMC. A disposable plastic, Gomco-like device should be produced and evaluated for use in resource-limited settings.
RCT Entities:
BACKGROUND: Voluntary medical male circumcision (VMMC) is a priority HIV preventive intervention. To facilitate male circumcision scale- up, the World Health Organization is actively seeking circumcision techniques that are quicker, easier, and safer than open surgical methods. OBJECTIVE: To compare conventional open surgical circumcision with suturing with a minimally invasive technique using the Gomco circumcision clamp plus tissue adhesive. METHODS: We conducted a non-blinded randomised controlled trial comprising 200 male volunteers >18 years of age, seen at the outpatient university teaching clinic of the Catholic University of Mozambique. We compared two interventions - open surgical circumcision with suturing v. Gomco instrument plus tissue adhesive. Our primary outcome was intraoperative time and our secondary outcomes included: ease of performance, post-operative pain, adverse events, time to healing, patient satisfaction and cosmetic result. RESULTS: The intraoperative time was less with the Gomco/tissue adhesive technique (mean 12.8 min v. 22.5 min; p<0.001). Adverse events were similar except that wound disruption was greater in the Gomco/tissue adhesive group, with no difference in wound healing at 4 weeks. Levels of satisfaction were high in both groups. The cosmetic result was superior in the Gomco/tissue adhesive group. CONCLUSIONS: This study has important implications for the scale-up of VMMC services. Removing the foreskin with the Gomco instrument and sealing the wound with cyanoacrylate tissue adhesive in adults is quicker, is an easier technique to learn, and is potentially safer than open surgical VMMC. A disposable plastic, Gomco-like device should be produced and evaluated for use in resource-limited settings.