Prospective, International, Randomized, Multicentric, Controlled Study on the Performance of SYMMCORA® Mid-term Unidirectional Barbed Suture Versus V-loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aesculap AG
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Suturing time to close the vaginal cuff
研究概览
简要总结
The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate.
Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females undergoing an elective, laparoscopic total hysterectomy
- •Age ≥ 18 years
- •Written informed consent
排除标准
- •Emergency surgery
- •Open surgery
- •Patients undergone immunosuppressive drug treatment within the prior 6 months
- •Patients with hypersensitivity or allergy to the suture material.
- •Participation in another clinical study
- •Non-compliance of patient
结局指标
主要结局
Suturing time to close the vaginal cuff
时间窗: intraoperatively
Measured in Minutes. Time to perform the vaginal cuff closure after laparoscopic total hysterectomy using a stop watch. Time starts when the needle passes the first time the tissue and ends after completion of the wound closure (cut of the needle from the thread).
次要结局
- Number of patients with complications over the study period(at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively)
- Number of patients with early complications(at discharge (up to 10 days after surgery))
- Number of patients with device deficiencies over the study period(intraoperatively, at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively)
- Progress of Patient's pelvic pain (VAS 0-100) compared to baseline(preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively)
- Progress of Patient's lumbar pain (VAS 0-100) compared to baseline(preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively)
- Patient assessment of postoperative Dyspareunia(at both follow-up visits (6-8 weeks postoperatively and 6 months postoperatively))
- Assessment of the handling of the barbed suture (SYMMCORA®) compared to conventional suture(intraoperatively)
- Progress of General Health Status compared to baseline(preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively)
- Patient satisfaction (VAS 0-100) over time(at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively)
- Overall operation time(intraoperatively)
- Cost of treatment(at discharge (approximately 10 days after surgery))
- Length of postoperative hospital stay(at discharge (approximately 10 days after surgery))
- Assessment of the handling of the barbed suture (SYMMCORA®)(intraoperatively)
- Assessment of the handling of the barbed suture (SYMMCORA®) compared to barbed suture (V-Loc)(intraoperatively)
- Progress of Female Sexual Function Index (FSFI) compared to baseline(Preoperatively (baseline), at follow-up visits 6-8 weeks postoperatively and 6 months postoperatively)
- Progress of Patient's abdominal pain (VAS 0-100) compared to baseline(preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively)