Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06244927 |
| Other study ID # |
2023-0699 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 23, 2023 |
| Est. completion date |
January 18, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Sir Run Run Shaw Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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)
