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临床试验/NCT06260241
NCT06260241Unknown不适用

Gain in Stretched Penile Length After Phalloplasty With & Without Penile Traction in Children.

Shaikh Zayed Hospital, Lahore1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
1
主要终点
The gain in stretched penile length (SPL)

研究概览

简要总结

The goal of this Randomized Controlled Trial is to assess the gain in stretched penile length after phalloplasty with & without penile traction in children of age group 4 to 13 years presenting in hospital with the complaint of concealed penis.

The main question[s] it aims to answer is:

• Gain in stretched penile length after phalloplasty with and without penile traction in children.

详细描述

Concealed penis is a rare clinical entity that affects young males. It leads to various concerns about cosmesis even though it does not necessarily affect functional aspects such as micturition and intercourse. However, data suggests that up to 4% of individuals may be affected by a concealed penis and this can lead to great distress to the patient especially as the child ages. There are different methods of phalloplasty that are performed, however none have explored the possible benefit of traction to the penis after phalloplasty to increase stretched penile length. We conducted a pilot study where we found a modest increase in stretched penile length following traction with phalloplasty and believe that addition of this step will help individuals with a concealed penis following phalloplasty gain a modest increase in length. The hypothesis of this study is that there will be a significant mean gain in stretched penile length with traction for 24 hours following phalloplasty for concealed penis. The research conducted will be a Randomized Control Trial with two groups where one group receives traction while one group does not.

The net gain in stretched penile length, stretched penile length pre-operatively and 2 weeks post-operatively will be analyzed using the independent study T-test with a P-value of 0.05 or less as significant between the two groups. The difference between the baseline SPL and post-operative SPL for each group will be assessed using the paired student t-test with a p-value less than 0.05 as significant. Sample Size for our study will be 70 patients (35 in each group).

Phalloplasty is a well-known procedure in children presenting with concealed penis as ordinary circumcision may lead to phimosis and adhesions formation between glans and skin in concealed penis. This procedure is not associated with any untoward results (except Suture Cut-through the glans skin which can be easily repaired) as only traction will be applied & SPL will be measured immediately per-op & two weeks post operatively.

Since there is currently no local study assessing the increase in stretched penile length following phalloplasty with traction, we have done a pilot study (Annexure B) whose results were satisfactory with penile traction as compared to without penile traction therefore, we anticipate a notable augmentation in stretched penile length both prior to and post the procedure in each patient. This observation implies that employing 24-hour penile traction may be a recommended course of action, potentially opening the door for more comprehensive investigations to furnish additional evidence regarding the procedure's advantages. It is important to acknowledge that this study will face limitations due to the restricted sample size, primarily attributable to the rare nature of the condition. Given the limited existing literature on the subject, the substantial prevalence of the condition, and the absence of a consensus regarding the optimal approach for concealed penis, this study could contribute to the existing body of knowledge by examining the efficacy of combining penile traction with phalloplasty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
4 Years 至 13 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Infants and children aged 4 years to 13 years of age.
  • Presenting with concealed penis for circumcision.

排除标准

  • Congenital Buried Penis
  • Webbed penis
  • Structural abnormalities of the penis such as hypospadias, Epispadias etc.
  • Existing co-morbid syndromes or conditions
  • Unfit for general anesthesia
  • Known bleeding diathesis
  • Incomplete foreskin
  • Any previous penile surgery

研究组 & 干预措施

With Traction Dressing

Other

Traction dressing will be applied to patients after phalloplasty for 24 hours.

干预措施: Traction Dressing (Procedure)

Without Traction Dressing

Other

No traction dressing will be applied to patients after phalloplasty for 24 hours.

干预措施: Without Traction Dressing (Other)

结局指标

主要结局

The gain in stretched penile length (SPL)

时间窗: up to 2 Years

To measure the gain in stretched penile length (SPL) following phalloplasty with and without penile traction applied for 24 hours for patients undergoing surgery for concealed penis at two weeks post-operatively.

次要结局

未报告次要终点

研究者

发起方
Shaikh Zayed Hospital, Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

ADEEL AHMED

POST GRADUATE RESIDENT

Shaikh Zayed Hospital, Lahore

研究点 (1)

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