Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 主要终点
- Pelvic Organ Prolapse Quantification
研究概览
简要总结
The investigators designed a prospective study in this article to evaluate the efficacy, the life quality and the complications of two different meshes of type I (one is Perigee/Apogee, the other is named Gynecare prolift) versus traditional surgery, and also studied the influence of some surgical procedures on the prognosis.
详细描述
Pelvic organ prolapse is defined as a downward descent of the pelvic organs that results in the protrusion of vagina, uterus, or both. The investigators designed a prospective study in this article to evaluate the efficacy, the life quality and the complications of two different meshes of type I (one is Perigee/Apogee, the other is named Gynecare prolift) versus traditional surgery. The investigators also studied the influence of some surgical procedures on the prognosis. In this study，The investigators divided the patients randomly into three groups :the group A was a total of 91 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction combined Perigee and Apogee polypropylene mesh(PA)；the group B was a total of 97 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction with Gynecare prolift polypropylene mesh；the group C was a total of 70 patients who accepted transvaginal hysterectomy and anterior and posterior vaginal wall repair without any mesh.The investigators did POP-Q measurements and questionnaire preoperatively and postoperatively and recorded volume of bleeding，day of postoperative indwelling catheter and the mesh complications。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Investigator)
盲法说明
In the study the operation was performed by three surgeons, the patients received surgery by the doctor when the patients saw in the outpatient clinic.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with stage III ~ IV degree of anterior and posterior vaginal wall prolapse and uterine prolapse (total pelvic floor prolapse) by the Pelvic Organ Prolapse Quantification System (POP-Q) were included
排除标准
- •Simple anterior or posterior wall prolapse, simple uterine prolapse, combined with stress urinary incontinence, overactive bladder (OAB), pelvic floor repair surgery history and recurrent patients
- •Local or systemic conditions that would preclude surgery or affect healing such as restricted leg motion (inability to conform to the lithotomy position)
- •Vaginal bleeding;coagulation disorders
- •Infection,or uncontrolled hypertension and diabetes mellitus
- •Pelvic cancer and radiation to the pelvic area in the previous 6 months.
- •Also women of reproductive age, and planning of pregnancy were also excluded for mesh usage.
结局指标
主要结局
Pelvic Organ Prolapse Quantification
时间窗: at 24 months after surgery
the prolapse of stage II and above is defined as recurrence in POP-Q stage.
mesh exposure
时间窗: at 24 months after surgery
mesh was seen in the vagina by gynecological examination
sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
时间窗: baseline
PISQ-12
pelvic floor distress inventory short form
时间窗: baseline
PFDI-20
次要结局
- Number of constipation(1 months after surgery)
- Volume of bleeding(during the operation)
- Day of postoperative indwelling catheter(1 months after surgery)
- Elevated blood pressure(during the operation)
- stress urinary incontinence(3 months after surgery)
研究者
Xirong Guo
Vice president of Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University
Nanjing Medical University