Abdominal Sacro-hysteropexy Using Proline Mesh Versus Mersilene Tape in Apical Prolapse: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- urinary retention
研究概览
简要总结
Sacro-hysteropexy Using Proline Mesh Versus Mersilene Tape in Apical Prolapse: a Randomized Controlled Study .Aim of This Study is to Compare Between Using Poly-proline Mesh Versus Mersilene Tape in Abdominal Sacrohysteropexy Repairing Apical Prolapse Stage 2 or More. Outcome Measures: Short Term: investigators Will Evaluate Operative Time, Blood Loss, Hospital Stay Duration, Occurrence of Major Complications, Episodes of Constipation, Urinary Retention and Urinary Tract Infection. Long Term (After 1 year): investigators Will Evaluate Occurrence of Relapse as Well as Late Complications. Local Symptoms, Quality of Life and Sexual Function Will be Evaluated by a Questioner Before and After Surgery
详细描述
Aim of this study is to compare between using poly-proline mesh versus mersilene tape in abdominal sacrohysteropexy repairing apical prolapse stage ӀӀ or more.
Study Design: This will be a prospective randomized controlled non blind study will include cases with apical prolapse stage 2 or more undergoing abdominal sling between October 2019 and September 2020 in Obstetrics and Gynecology Department, Ain Shams University Hospital and menofia university hospital.
Inclusion Criteria: Women planning sacrohysteropexy for stage 2, 3, or 4 prolapse with or without stress urinary incontinence, Age between 25 and 45, Patient has no uterine pathology necessitate hysterectomy and patient wish to retain her uterus.
Exclusion Criteria:Unfitness for anesthesia, Present pelvic inflammatory disease, Previously identified or suspected massive adhesions between sigmoid and pre-sacral peritoneum, Previous pelvic operations or trial of sling operation.
Prolapse is staged with the use of the pelvic-organ-prolapse quantification (POP-Q) system, a standardized quantitative method for assessment of prolapse. PISQ-12 assesses the sexual function of the woman with prolapse. Urinary incontinence is ruled out by history, examination and urodynamic study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
participants will be aware of procedure but unaware of the material used for repair
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women planning sacrohysteropexy for stage 2, 3, or 4 prolapse with or without stress urinary incontinence.
- •Age between 25 and 45
- •Patient has no uterine pathology necessitate hysterectomy and patient wish to retain her uterus.
排除标准
- •Unfitness for anesthesia
- •Present pelvic inflammatory disease
- •Previously identified or suspected massive adhesions between sigmoid and pre-sacral peritoneum.
- •Previous pelvic operations or trial of sling operation
结局指标
主要结局
urinary retention
时间窗: 24 hours
inability to pass urine after catheter removal
operative time
时间窗: 60 minutes
time taken from start of operation till its end
blood loss
时间窗: during surgery time
amount in CC
occurrence of major complications as vascular injury or ureteric injury
时间窗: during surgery
injury
hospital stay duration
时间窗: 24 hours
how many hours patient stay in hospital after procedure till discharge
次要结局
- occurrence of relapse(1year after procedure)
- erosion(1 year after procedure)
研究者
Mohamed Elsibai Anter
principal investigator
Menoufia University