Clinical trial NCT06244927: Replantation Following Complete Penile Amputation
Official title: Replantation Following Complete Penile Amputation: Summary of Perioperative Experience and Treatment Strategies Before and After Case Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Penile Amputation
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 20
Sex: MALE
Minimum age (years): 6
Maximum age (years): 58
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received replantation surgeries following penile amputation.

Brief summary: 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.

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: International Index of Erectile Function (IIEF)
timeFrame: 6 months
Secondary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Hanchao Liu
role: STUDY_CHAIR
References: