At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision
In Brief
A clinical study evaluating Gomco Clamp with Tissue Adhesive and Open surgical circumcision for Surgical Technique. Completed, enrolled 200 participants across 1 site.
Detailed Summary
This proposed randomized controlled trial will provide important data which will inform and enable the Mozambican government and global health programs to more effectively scale-up circumcision services. The investigators postulate that voluntary medical male circumcision using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method: it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and is more cost effective than any other currently available technique.
Study Details
Timeline
Interventions
According to WHO (2011), the Gomco clamp has "…an impeccable safety record. In the USA, where it is estimated that well over 1 million neonates are circumcised each year, the Gomco clamp has become the leading instrument used to perform non-ritual male circumcision." Tissue adhesive is widely used in multiple areas of medicine; specifically, multiple observational studies and RCTs have shown cyanoacrylate tissue adhesives to be superior to suture closure in VMMC.
The World Health Organization, in its Manual for Male Circumcision under Local Anaesthesia, describes three open surgical techniques (forceps assisted, dorsal slit and sleeve technique), all three of which involve (a) exposure of subcutaneous tissues and (b) suturing for hemostasis and for skin closure.