A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Intraoperative Duration
研究概览
简要总结
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.
详细描述
Voluntary medical male circumcision (VMMC) is a priority preventive intervention and Mozambique is a priority country for VMMC scale-up. PEPFAR recently estimated that one HIV infection would be prevented between now and 2025 for every seven circumcisions performed in Mozambique. Sofala Province, where the study will be conducted, has an HIV prevalence of 13% among men and 18% among women. Approximately 8% of men aged 15-49 in Sofala Province, where the study will take place, are currently circumcised.
In spite of their widely acknowledged drawbacks, open surgical techniques are the only VMMC techniques the President's Emergency Plan for AIDS Relief (PEPFAR) program currently allows in Africa. According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up."
This proposed randomized controlled trial will provide important data which will inform and enable the Mozambican government and PEPFAR to more effectively scale-up circumcision services. The investigators postulate that VMMC 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.
The investigators propose a randomized controlled trial (RCT) comparing this minimally-invasive circumcision technique to the open surgical technique:
- Gomco clamp with tissue adhesive: 100 men
- Open surgical circumcision: 100 men
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men > 18 years of age requesting circumcision
- •No penile anatomical abnormalities or infections
- •Able to provide informed consent to participate
- •Willing to participate in follow-up visits
排除标准
- •Current illness
- •Penile abnormality or infection which contraindicates or would complicate circumcision
- •History of bleeding disorder
- •Past reaction to local anesthetic
结局指标
主要结局
Intraoperative Duration
时间窗: 1 year
Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.
次要结局
- Difficulty in Learning and Performing Technique(1 year)
- Time Required for Healing(Within 6 weeks after surgery)
- Direct Costs(Within 6 weeks after surgery)
- Pain Experienced(2 days after surgery)
- Overall Patient Satisfaction(Within 6 weeks after surgery)
- Cosmetic Result(Within 6 weeks after surgery)
研究者
Dr. Peter Millard
Clinical Director of the Health Center
Universidade Católica de Moçambique