Comparison of Suturing Technique Types on Pubocervical Fascia at Colporrhaphy Anterior for Cystocele Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Objective success
研究概览
简要总结
Anterior colporrhaphy is the commonly performed surgery for pelvic organ prolapse. However the success rates of native tissue repair techniques for anterior vaginal prolapse range from %30-%70. According to a systematic review of the anterior colporrhaphy technique, there was no ideal procedure or guideline for gynecologists to perform. The investigators tried to compare pubocervical fascia suturing techniques with the ideal procedure type by determining step by step all parts of the surgery including the anesthesia type. The aim of the study will be to compare the pubocervical fascia reconstruction techniques in the management of anterior compartment defects (POP-Q >2) at 1 year and yearly up to 2 years.
详细描述
Primary and secondary endpoints:
Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total.
Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations.
The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment.
Project design: The investigators will perform an international singlecentre single-blind randomized controlled trial by participating in our tertiary referral hospital.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) cystocele
- •Women aged between 18-75 years of age
排除标准
- •Women not eligible for surgery for medical or anesthesiological reasons
- •Inability to comprehend questionnaires
- •Inability to give informed consent
- •Inability to return for a review
- •Prior anterior compartment repair with or without mesh
- •Severe cardiovascular or respiratory disease
- •Women who don't want anterior compartment repair
- •Pregnancy
- •Age <18 years
研究组 & 干预措施
Transverse separated suturing technique
During pubocervical fascia reconstruction, the surgeon will perform suturing at the transverse plane with an intermittent stitching technique.
干预措施: Pubocervical fascia reconstruction (Procedure)
circular continue suturing technique
During pubocervical fascia reconstruction, the surgeon will perform a continuous stitching technique which includes the lateral parts of the anterior compartment defect.
干预措施: Pubocervical fascia reconstruction (Procedure)
结局指标
主要结局
Objective success
时间窗: Time Frame: 12 months after intervention
Defined as anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total
Subjective cure rate of prolapse
时间窗: Time Frame: 12 months after intervention
Provided by the patient's feeling of the "Absence of a bulge in the vagina"
次要结局
- Failure (%)(Time Frame: 12 months after intervention)
- Prolapse-related Quality of life(Time Frame: 12 months after intervention)
- Complications(Time Frame: 12 months after intervention)
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)(Time Frame: 12 months after intervention)
- Incontinence Impact Questionnaire (IIQ-7)(Time Frame: 12 months after intervention)
- Pelvic Floor Distress Inventory (PFDI - 20)(Time Frame: 12 months after intervention)
研究者
Ozan Karadeniz
Principal investigator
Kanuni Sultan Suleyman Training and Research Hospital