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临床试验/NCT06244927
NCT06244927已完成不适用

Replantation Following Complete Penile Amputation: Summary of Perioperative Experience and Treatment Strategies Before and After Case Study

Sir Run Run Shaw Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年11月23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
20
试验地点
1
主要终点
International Index of Erectile Function (IIEF)

研究概览

简要总结

The goal of this observational study Replantation following Complete Penile Amputation a case series before and after study is to help andrologist and urologists deal with such rare male emergencies easily in emergency situation. There are only limited case reports of penile amputation, a rare urological emergency with a low treatment success rate, and there are still no advanced, detailed surgical or perioperative treatment plans.The main question[s] it aims to answer are:

•The investigators used questionnaire to ask participants who undergo replantation surgery to reply. These are the International Index of Erectile Function (IIEF) before and after surgery; the International Prostate Symptom Score (IPSS) estimate for urination after surgery; the Quality of Life index (QoL) estimate, which characterized quality of life into 7 categories: happy (0), satisfied (1), general satisfied (2), not bad (3), not too satisfied (4), distressed (5), and terrible (6). The appearance satisfaction score was based on four levels: from unsatisfactory (1), slight unsatisfactory (2), satisfactory (3) to very satisfactory(4).

Participants (Patients) only need to reply question above. This is observational before and after case study.

详细描述

Twenty participants (aged 6-58 years) who were treated at investigators' hospital over the past years and ultimately underwent surgery and follow-up assessment were included. The relevant research was approved by the Ethics Committee of Sir Run Run Shaw Hospital, Approval NO.: 2023-0699. All 20 amputated phalli were adequately preserved; the neurovascular structures in the proximal stump were readily identified and in a suitable condition for anastomosis. All of these parameters were evaluated by the investigators, who believed that anastomosis could be attempted. The surgery was performed under the guidance of the investigators, and the same surgical methods were used. Surgical methods and perioperative processes were performed as described below. The participants' preoperative erectile functions and urination scores are shown in Table 1. Each of the participants and their families desired penis replantation after the accident, even if the amputation occurred because of a psychological disorder. A participant may not be willing to undergo replantation due to psychological issues, but their families are supportive of replantation. And surgeons believe that there is high probability of successful anastomosis creation. This participant was constraint to undergoing treatment. The participants' details can be found in Table 1. The investigators used the International Index of Erectile Function (IIEF) before and after surgery; the International Prostate Symptom Score (IPSS) estimate for urination after surgery; the Quality of Life index (QoL) estimate, which characterized quality of life into 7 categories: happy (0), satisfied (1), general satisfied (2), not bad (3), not too satisfied (4), distressed (5), and terrible (6). The appearance satisfaction score was based on four levels: from unsatisfactory (1), slight unsatisfactory (2), satisfactory (3) to very satisfactory(4)

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
6 Years 至 58 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients who received replantation surgeries following penile amputation. And complete follow-up data.

排除标准

  • Patients who not received replantation surgeries following penile amputation. Or Incomplete follow-up data.

结局指标

主要结局

International Index of Erectile Function (IIEF)

时间窗: 6 months

Revealing the quality of the patient's erectile function

次要结局

  • International Prostate Symptom Score (IPSS)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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