Risk Factors for Recurrence After Pelvic Reconstruction of Pelvic Organ Prolapse：1 Year Follow-up in Patients Implanted Hernia Mesh and Biological Graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 主要终点
- recurrence
研究概览
简要总结
232 women underwent transvaginal mesh repair (TVM)with /without transvaginal hysterectomy for symptomatic POP, including group A（accepted herniamesh polypropylene mesh， 117 patients)；group B （underwent biological graft of cook，115 patients)；follow-ups for six months and one year after the surgery and a questionnaire about the life habits associated with relapse.
详细描述
We prospectively study a total of 232 women who underwent transvaginal mesh repair (TVM)with /without transvaginal hysterectomy for symptomatic POP, the patients into two groups :group A was accepted herniamesh polypropylene mesh(117)；group B underwent biological graft of cook(115)；Each patient underwent an interview that included a POP-Q which was quantified according to the Pelvic Organ Prolapse Quantitation (POPQ) system;follow-ups for six months and one year after the surgery and a questionnaire about the life habits associated with relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 52 Years 至 76 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •242 postmenopausal patients with primary prolapse of the anterior vaginal wall or concomitant uterine prolapse,that was stage Ⅲ or higher (according to the Pelvic Organ Prolapse Quantification [POP-Q] system).
排除标准
- •pelvic floor repair surgery history and recurrent patients ; pelvic cancer and radiation to the pelvic area in the previous 6 months; simple uterine prolapse; combined with severe stress urinary incontinence or overactive bladder (OAB); 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; infection; coagulation disorders; uncontrolled hypertension and diabetes mellitus;
研究组 & 干预措施
group A
accepted herniamesh mesh
干预措施: herniamesh (Device)
group B
accepted biological graft of cook
干预措施: biological graft (Device)
结局指标
主要结局
recurrence
时间窗: at 12 months after surgery
Recurrence was defined as a POP-quantification system stage ≥IIb or any symptomatic prolapse.
次要结局
- perioperative complications(12 months after surgery)
研究者
Xirong Guo
Vice President of Nanjing maternity and child Health Care Hospital
Nanjing Medical University