Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Short term complication rate
研究概览
简要总结
To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.
详细描述
Testicular implants made from various materials have been in use since 1941. The lack of a testicle has proven to be a psychologically traumatic experience for men of all ages. Therefore, testicular implants are placed in the scrotum for various reasons on request of the patient.The intended target population for the silicone gel-filled testicular implants of Groupe SEBBIN is any patient (children or adults) with agenesis or testicular atrophy, undescended testicle, testicular tumour, epididymitis / orchitis, or a trauma, for whom an orchidectomy with placement of a testicular prosthesis is indicated. Testicular implants are also indicated for sex reassignment surgeries.
The main complications after testicular implant placement recorded in the literature include extrusion, scrotal contraction, pain, hematoma, and infection. The literature about testicular implant is sparse, and no report on the use of SEBBIN silicone gel-filled testicular implants have been identified in the scientific literature.
The Gel-filled Testicular Implant medical devices are manufactured by GROUPE SEBBIN under the brand name 'Laboratoires SEBBIN'. The Gel-filled Testicular Implant medical devices are presented sterile (Ethylene oxide sterilization) and are double wrapped for single use.
The medical grade raw materials used for the manufacturing of these prostheses are bio-compatible and completely traceable. The substances belong to the polydimethylsiloxane family.
This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather data on the safety and effectiveness of the device. For this purpose, the overall short and long term complication rate and complication grade. Secondly, the investigators evaluate patient satisfaction and quality of life by use of questionnaires
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 110 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is an adult or a child at the time of testicular implant placement.
- •The patient is a candidate to unilateral or bilateral testicular implant placement.
- •The patient has been informed of the study, has read the patient information letter and provided oral and written consent.
- •If the patient is of French nationality, he/she must be affiliated to the French Social Security.
排除标准
- •The patient has silicone implants somewhere else than in the scrotal sac (except for a penile prosthesis).
- •The patient was diagnosed with one of the following pathologies:
- •Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
- •Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
- •Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.
- •The patient has any other underlying condition that could delay healing.
- •Custom-designed implants are used for surgery.
结局指标
主要结局
Short term complication rate
时间窗: Within 90 days postoperatively
Cathegorized according to Clavien-Dindo Classification
Long term complication rate
时间窗: At 2 years of follow-up
Desciption of overall complications related to testicular prosthesis placement.
次要结局
- Body image of scrotum(Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up)
- Change in self-esteem scoring(Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up)
- Satisfaction with prosthesis(Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up)