Replantation Following Complete Penile Amputation

NCT ID: NCT06244927

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-23
• Study Completion Date: 2024-01-18

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)

Conditions

Penile Amputation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Only 20 patients undergo replantation following penile amputation were investigate, only 1group

Patients undergo surgery.

Replantation surgery

Intervention Type: PROCEDURE

Surgery

Interventions

Replantation surgery

Surgery

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 58 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanchao Liu

Role: STUDY_CHAIR

Sir Run Run Shaw Hospital

Locations

Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2023-0699

Identifier Type: -

Identifier Source: org_study_id