Is Absorbable Suture Non-Inferior to Permanent Suture in Sacrospinous Ligament Suspension? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Pelvic Organ Prolapse Quantification (POP-Q) exam Point C
研究概览
简要总结
Sacrospinous ligament suspension (SSLS) was first described in 1958. It is commonly performed for correction of apical prolapse. A combination of delayed absorbable and/or permanent sutures are commonly used for the procedure. When permanent sutures are used, risk of suture-related complications is present and patients may require suture removal. In available literature, there is limited data comparing the efficacy and suture-related complications when using different types of sutures. A previous randomized controlled trial demonstrated that using an absorbable suture is equally efficacious as delayed absorbable sutures in SSLS. However, there is no comparison to absorbable versus permanent suture. Our aim is to compare the absorbable suture versus permanent suture for treating pelvic organ prolapse and to compare suture-related complications.
Our primary outcome is comparing POPQ point C at 12 month follow up for absorbable vs permanent suture.
Participants will be randomized 1:1 to absorbable or permanent suture. Follow up will occur at 2-4 weeks, 12 weeks and 12 months after the surgery.
详细描述
Patient demographics, previous medical and surgical history, baseline physical exam including POP-Q will be collected from the electronic medical record following enrollment. This information will be stored in REDCap which is a secure database system.
Patients will be randomized by in REDCap system with the sequence of 1:1 with blocks of 6.
Patients and assessors will be blinded to the type of suture that was used. The surgeons will not be blinded.
All procedures will be performed by a fellowship-trained, Female Pelvic Medicine and Reconstructive Surgery board-certified surgeon.
Sacrospinous ligament suspension (SSLS) procedure with the assigned suture and any scheduled concomitant prolapse and anti-incontinence procedures will be performed.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients of Atlantic Urogynecology Associates undergoing sacrospinous ligament suspension procedure at Morristown and Overlook Medical Centers
排除标准
- •Patients who did not undergo sacrospinous ligament suspension procedure based on surgeon's intraoperative decision
- •Patients with current gynecologic malignancies
- •Patients with history of pelvic radiation
- •Patients with history of prolapse repair surgery
结局指标
主要结局
Pelvic Organ Prolapse Quantification (POP-Q) exam Point C
时间窗: 12 months
Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. A provider who is blinded to the type of suture used will conduct postop POPQ exam.
次要结局
- Prolapse Recurrence(12 months)
- PGI-I(12 months)
- Suture-related Complications(12 months)
研究者
Laura Dhariwal, MD
Principal Investigator
Atlantic Health System