NCT02320643已完成不适用
A Prospective Pilot Study to Investigate the Efficacy of Partially Absorbable Mesh(Seratom PA®) in Patients With Pelvic Organ Prolapsed
Samyang Biopharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pelvic Organ Prolapse Quantification(POP-Q) stage
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, recurrence, postoperative complications of partially absorbable mesh(Seratom®PA) in patients with pelvic organ prolapse.
详细描述
Patients with pelvic organ prolapse are administrated partially absorbable mesh(Seratom®PA). It is performed pelvic organ prolapse quantification(POP-Q) examination, quality of life(QOL) questionnaire complications at postop 2week, 12week, 24week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 41 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman who aged 41 years or older
- •Subjects who have symptomatic pelvic organ prolapse quantification(POP-Q) stage II & cystocele or higher requiring surgical repair
- •Subjects who desires vaginal reconstructive surgery
- •Subjects who have uterus < 12 weeks size
- •Subjects who are able to complete study questionnaires and assessment
- •Subjects who are available for 6 months follow-up
排除标准
- •Subjects who have medical contractions, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use, or a compromised immune system
- •Subjects who have received anticoagulation therapy
- •Subjects who are on current intermittent catheterization
- •Subjects whose BMI is over 30kg/m2
- •Subjects who have uncontrolled diabetes
- •Subjects who are on any medication which could result in compromised immune response, such as immune modulators
- •Subjects who are currently pregnant or intends to become pregnant during the study period or <12 months post-partum
- •Subjects who have received other laparoscopic or abdominal or pelvic surgery in the past 1 months
- •Subjects who need for concomitant surgery requiring an abdominal incision
- •Subjects who have had a prior prolapse implant procedure (i.e. IVS tunneler, Perigee, Apogee, graft augmented repair, etc)
- •Note: previous traditional repairs are allowed.
- •Subjects who have had radiation therapy to the pelvic area
- •Subjects who have pelvic cancer or have had pelvic cancer within the past 12 months or have had on cytostatic medication within the past 12 months
- •Subjects who have a shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys.)
- •Subjects who have a known neurologic or medical condition affecting bladder function (e.g. Multiple Sclerosis, spinal cord injury)
- •Subjects who have a known hypersensitivity to the graft material(s)
结局指标
主要结局
Pelvic Organ Prolapse Quantification(POP-Q) stage
时间窗: Change from baseline in Pelvic Organ Prolapse Quantification(POP-Q) stage at postop 2week, 12week, 24week
Surgical revision rate
时间窗: For post op 6 months from baseline
次要结局
- No of patients complications occurred(For post op 6 months from baseline)
研究者
研究点 (1)
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