Penile AmputationNCT06244927
Replantation Following Complete Penile Amputation
An observational study of Penile Amputation, run by Sir Run Run Shaw Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 6 to 58 years, men only
- Conditions the study is for
- Penile Amputation
- What is being tested?
- Replantation surgery
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2023to 18 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 58 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Patients who received replantation surgeries following penile amputation.
Who may be able to join
- Patients who received replantation surgeries following penile amputation. And complete follow-up data.
Who cannot join
- Patients who not received replantation surgeries following penile amputation. Or Incomplete follow-up data.
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, 31002
About this study
Official title: Replantation Following Complete Penile Amputation: Summary of Perioperative Experience and Treatment Strategies Before and After Case Study
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.
Read the 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)
- Conditions
- Penile Amputation
- Being tested
- Replantation surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replantation surgeryProcedure or surgery
Surgery
| Study group | Role | What they receive |
|---|---|---|
| Only 20 patients undergo replantation following penile amputation were investigate, only 1group | Patients undergo surgery. Receives: Procedure: Replantation surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function (IIEF)
Revealing the quality of the patient's erectile function
Measured: 6 months
Secondary outcomes (1)
International Prostate Symptom Score (IPSS)
Revealing the quality of the patient's urination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start23 Nov 2023
- Primary completion20 Dec 2023
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanchao Liu, Study chair, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244927
- Sponsor's protocol ID
- 2023-0699
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data can be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replantation Following Complete Penile Amputation: Summary of Perioperative Experience and Treatment Strategies Before and After Case Study
- ClinicalTrials.gov ID
- NCT06244927
- Acronym / sponsor ID
- 2023-0699
- Conditions
- Penile Amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only 20 patients undergo replantation following penile amputation were investigate, only 1group | – | Procedure: Replantation surgeryPatients undergo surgery. |
Who may qualify
- Ages
- 6 to 58 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who received replantation surgeries following penile amputation.
Key inclusion criteria (1 listed)
- Patients who received replantation surgeries following penile amputation. And complete follow-up data.
Key exclusion criteria (1 listed)
- Patients who not received replantation surgeries following penile amputation. Or Incomplete follow-up data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Replantation surgerySurgery | Procedure or surgery | Only 20 patients undergo replantation following penile amputation were investigate, only 1group |
Primary outcome
International Index of Erectile Function (IIEF)
Time frame: 6 months
Revealing the quality of the patient's erectile function
1 secondary outcome
International Prostate Symptom Score (IPSS)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No. Individual participant data can be shared upon reasonable request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanchao Liu study chair
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Penile Amputation, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function (IIEF) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024; AzTrials last refreshed its copy on 31 Oct 2026.