NCT06055946已完成不适用
Prospective, Multicenter, Single-arm Study on the Performance of Symmcora® Long-term Bidirectional Barbed Suture for Vesicourethral Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Time to perform the vesicourethral anastomosis
研究概览
简要总结
The aim of this observational study is to show the superiority of the bidirectional barbed suture (Symmcora® Longterm) in terms of time to perform the vesicourethral anastomosis after robot assisted radical prostatectomy compared to the available literature data, without an increase in the complication rate.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients undergoing an elective robotic assisted radical prostatectomy
- •Written informed consent
- •Age ≥ 18years
排除标准
- •Emergency surgery
- •History of chronic steroid use
- •Previous prostatic surgery
- •Previous radiotherapy or brachytherapy
- •Patients with hypersensitivity or allergy to the suture material.
- •Participation in another study
- •Non-compliant patient (dementia etc)
结局指标
主要结局
Time to perform the vesicourethral anastomosis
时间窗: intraoperatively
Time to perform the vesicourethral anastomosis using a stopwatch. Time starts when the needle passes the first time the tissue and ends after completion of the anastomosis. Completion of the anastomosis is defined by the last cut of the thread.
次要结局
- Amount of estimate blood loss (EBL)(intraoperatively)
- Anastomotic leak rate until 6 months postoperatively(up to 6 months after surgery)
- Transfusion rate(at discharge from hospital (approximately 5-10 days after surgery))
- Urinary fistula rate(until 6 months postoperatively)
- Rate of other complications(until 6 months postoperatively)
- Operation consola time(intraoperatively)
- Urinary retention(at 6 weeks postoperatively)
- Bladder neck contracture rate(until 6 months postoperatively)
- Urinary stone formation rate(until 6 months postoperatively)
- Development of Erectile Function compared to baseline(Preoperatively (Baseline), 6 weeks, 3 months and 6 months postoperatively.)
- Early continence(6 weeks postoperatively)
- Time to perform the Rocco stitch(intraoperatively)
- Catheterization duration(until first follow-up (6 weeks postoperatively))
- Development of continence by 24-h pad test(at 3 months and 6 months postoperatively.)
- Length of postoperative stay(until discharge (approximately 5-10 days postoperatively))
- Development of International prostate symptom score (IPSS) compared to baseline(Preoperatively (Baseline), 6 weeks, 3 months and 6 months postoperatively.)
- Comparison of Prostate Specific Antigen (PSA) at screening and 6 weeks after surgery.(at screening and 6 weeks after surgery.)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Unidirectional Barbed Sutures in Mucogingival ProceduresWound HealNCT04937114SVS Institute of Dental Sciences12
招募中
不适用
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total HysterectomyAbnormal Uterine BleedingUterine CancerEndometriosisUterine ProlapseFallopian Tube CancerEndometrial CancerOvarian CancerCervical CancerNCT06024109Aesculap AG132
Unknown
不适用
Comparison of Barbed and Conventional Sutures in Adhesion Formation Following Cesarean SectionCesarean SectionNCT03183362Cairo University110
已完成
不适用
Analysis of Standard Versus Barbed Sutures in Primary Total Knee Arthroplasty.Arthropathy of KneeNCT01320371University of Utah363
已完成
3 期
Barbed Versus PGA Sutures in Minimally Invasive Dismembered PyeloplastyPelvi-Ureteric ObstructionNCT06526559Cairo University40