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临床试验/NCT03149692
NCT03149692已完成不适用

Penile Allograft Transplantation for Men With Penile Loss After Ritual Circumcision

University of Stellenbosch2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2011年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
2
主要终点
Sexual function

研究概览

简要总结

One case of unsuccessful penile transplantation has been reported from China. The patient had suffered an industrial machine accident and lost his penis to the level of the pubic skin. Unfortunately the patient's wife insisted at about two weeks post-operatively that the organ be removed. At the time of surgical removal the penis was viable, except for a degree of superficial skin necrolysis. This has sparked debate on ethical issues regarding penile transplantation. South Africa is uniquely positioned in Sub-Saharan Africa and worldwide with relatively advanced medical services and a high prevalence of ritual circumcision practice with reports of high morbidity and mortality in the last 20 years. The substantial number of young men left with a severe penile defect or complete loss of the penis [9] creates a possible place for penile allograft transplantation as a treatment option.

详细描述

Literature review and rationale Ritual circumcision has been practised for centuries in Africa and other parts of the world. Clinical trials have shown that adult male circumcision, if performed correctly, could play a role in the prevention of HIV transmission and protect against invasive penile cancer. The prevalence of ritual circumcision practiced in Eastern and Southern Africa varies from about 80% in Kenya to about 20% in Uganda and Southern Africa. The procedure referred to as ritual circumcision is performed in a non-clinical environment by a traditional circumcisionist with no formal medical training. The main geographical area for this rite of passage in South Africa is among the Xhosa-speaking people of the Eastern Cape.

The complications of this procedure may lead to severe genital mutilation with partial or complete penile loss and may even result in mortality. In a study by Meissner and Buso conducted in the Eastern Cape from 2001 to 2005 there were 1748 hospital admissions, 107 genital mutilations and 177 deaths caused by ritual circumcision. Septicaemia, pneumonia and dehydration were the most common causes of death. The extent of genital mutilation varied from partial loss of the glans or distal penile shaft and urethra, to complete loss of the penis due to gangrene. Less common complications of ritual circumcision include polyarticular septic arthritis. The complication rates of ritual circumcision are much higher than those reported for infant and neonatal circumcision (1-7%) where the complications are mostly minor and almost never result in penile loss However, in a systematic review of the literature Wilcken et al found that the acquisition of data from the ritual circumcision studies was often poor, as only 11 of 1639 articles reviewed were suitable for analysis. Other causes of penile loss include electrical burns, self-mutilation and shotgun wounds. These aetiologies are rare in South Africa in contrast to the large numbers of ritual circumcision related penile amputees.

Figure 2. Loss of penis after a ritual circumcision complication and a ventilated critically ill patient with a septic penis after ritual circumcision. (Own pictures) The current treatment for total penile loss is surgical total penile reconstruction (TPR), also called total phallus reconstruction. The goal of TPR is to create a cosmetically acceptable, sensate penis, functional urethra that extends up to the distal glans which permits voiding in a standing position, and providing enough bulk to allow the insertion of a penile prosthesis for sexual intercourse. In addition, the donor-site should cause minimal morbidity and should be easy to conceal. The above goals are difficult to obtain in South African state patients, as penile prostheses are not available due to their high cost (about ZAR 80 000 per inflatable prosthesis).

The most widely used TPR technique is a radial forearm free flap (RFFF) described by Song et al in 1982. However the urethrocutaneous fistula rate is up to 40% and the donor site morbidity around 9%. The tissue flap is taken from the inside of the forearm and the defect covered with a skin graft. The flap is fashioned into the shape of a penis and a skin tube created inside to connect to the urethra. This flap may contain radial bone to provide rigidity and enable sexual function. Radial bone harvesting increases the morbidity of the donor site, as the forearm becomes very thin distally. The operation takes around 7 - 10 hours to perform. It provides a phallus which is cosmetically acceptable after tattooing the glans penis, but completely incapable of sexual function without a prosthesis, if bone is not incorporated. In a series of 15 adult female to male gender reassignment patients, only 7 received prostheses, indicating that not all TPRs are suitable to receive a prosthesis.

An artificial penile prosthesis is expensive and not available to state patients in SA due to lack of funding. These prostheses can extrude (especially with repeated sexual intercourse) or become infected. Jarow et al found 21.7% risk of infection if a penile reconstructive procedure was done with prostheses surgery. Infection of prostheses normally necessitates removal.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients 18 years or older with total or partial penile loss as a complication from ritual circumcision, who are willing and able to provide written, informed consent.

排除标准

  • Immunosuppression (HIV positive, diabetes mellitus or drugs affecting immune response) Active tuberculosis (TB) or a history of TB Previous forearm free flap Disorders of circulation (e.g. peripheral vascular disease, vasculitis) History of prior malignancy Renal failure and not on a renal replacement programme Systemic disease deemed by the investigator serious enough to preclude the use of immunosuppression agents Mental illness Patients who are unwilling, unable or unlikely to comply with immunosuppressive treatment and regular follow-up.

结局指标

主要结局

Sexual function

时间窗: 3 months

Normal sexual intercourse as for the subject - with or without medication assistance measured with IIEF score

Quality of life score

时间窗: 6 months post operative

Improved (or not) measured QoL with SF 36 software

Urinary function

时间窗: 3 months after surgery

Normal standing urination (subjects/patients had to sit to urinate before)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andre van der Merwe

Associate Professor

University of Stellenbosch

研究点 (2)

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