PDS (Polydiaxonene Suture) Versus Prolene (Polypropylene Suture) as Suture Material for Vaginal Sacrospinous Hysteropexy - a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- German pelvic floor questionnaire (subjective symptom improvement)
研究概览
简要总结
Introduction: Pelvic organ prolapse is a common gynecological disease, which about 50% of women develop in the course of their lives. There are many different options for surgical care, e.g. the uterus-preserving sacrospinal fixation (= sacrospinal hysteropexy = SSHP). This technique has been increasingly used in recent years. However, there is still no data on whether the fixation sutures should be performed with absorbable or non-absorbable threads. Internationally, both types of threads are routinely used and both types of threads are described in publications. So far, there is no comparative data on the effectiveness and subjective results. The aim of this study is to compare subjective symptom improvement Materials & Methods: This is a randomized, single-center superiority study. The sacrospinal fixation is performed according to a standardized method and two different types of threads (absorbable PDS sutures vs. non-absorbable Prolene sutures) are used for the fixation suture. Patients are randomized to either the absorbable PDS sutures group or the non-absorbable Prolene sutures group. The primary outcome of interest is the subjective symptom improvement 12 months after surgery (evaluated using the German version of the pelvic floor questionnaire). Secondary outcome variables are anatomical outcomes, condition-specific quality of life, and adverse events. 52 patients will be included in the study.
The results of the study will be published in peer-reviewed journals and the results will be presented at scientific meetings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Anterior vaginal wall prolapse beyond the hymen (POP-Q-point Aa or Ba >0) with central defect
- •Prolapse of the apical vaginal vault beyond the hymen (POP-Q point C >0) with central defect
- •Symptoms of a vaginal bulge
- •A primary reconstructive operation using sacrospinous hysteropexy is planned
排除标准
- •Recurrent prolapse
- •History of hysterectomy
- •A primary reconstructive operation with mesh or obliterative surgery is planned
- •An operation with hysterectomy is planned
- •Known pelvic malignancy
- •Known inflammatory disease
- •Current systemic treatment with glucocorticoids or immunosuppressants
- •The subject cannot or does not want to participate
结局指标
主要结局
German pelvic floor questionnaire (subjective symptom improvement)
时间窗: 12 months post surgery
subjective symptom improvement 12 months after surgery evaluated using the German version of the pelvic floor questionnaire, which consist of 4 domains and a total of 42 questions
次要结局
- anatomical outcomes - POP-Q measurement(12 months post surgery)
- Mini Nutritional Assessment(12 months post surgery)
- Visual Analog Scale(12 months post surgery)
- anatomical outcomes - ultrasound imaging(12 months post surgery)
- German pelvic floor questionnaire (condition-specific quality of life)(12 months post surgery)
- Clavien Dindo Scale for adverse events(12 months post surgery)
- Numerical Rating Scale(12 months post surgery)
- Patient Impression of Improvement Index(12 months post surgery)
研究者
Greta L Carlin, Dr.med.univ
Dr. med. univ.
Medical University of Vienna