BEST: Barbed-suture Efficiency Study for Sacrocolpopexy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Time to complete vaginal graft attachment
研究概览
简要总结
Minimally invasive sacrocolpopexy (SCP) performed laparoscopically or with robotic assistance is associated with improved patient-centered outcomes such as faster recovery times, less pain, less bleeding, and shorter hospital stay, however at the expense of longer operating times. One of the time consuming parts of the procedure is vaginal mesh attachment.
详细描述
The purpose of this research study is to compare two different suture types that are used to attach vaginal mesh that is typically used in women undergoing robotic or laparoscopic sacrocolpopexy (attachment of the vagina to the sacral promontory). The barbed suture is one continuous suture, while the delayed absorbable suture involves placing individual sutures and tying a knot for each. All women will have permanent sutures that attach the mesh to the sacral promontory, which is standard of care. The goal is to determine if the barbed delayed absorbable suture decreases the time of vaginal mesh attachment.
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)
盲法说明
Patient will be masked to their allocation and post-operative examiners will be masked at the 6 week, 6 month, and 12 month visits
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject must have apical with anterior or posterior vaginal prolapse with leading edge of prolapse to or beyond the hymen
- •Subject reports a bothersome bulge they can see or feel per Pelvic Floor Disability Index (PFDI-20), question 3, response of 2 or higher
- •Eligible for laparoscopic or robotic sacrocolpopexy
- •Desires surgical treatment for symptomatic uterovaginal or vaginal vault prolapse
- •English speaking
排除标准
- •Patients who are not surgical candidates due to medical comorbidities
- •Current foreign body complications (including but not limited to erosion, fistula, abscess). This covers foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
- •Inability to give informed consent or to complete the testing or data collection.
- •Anticipated circumstances resulting in an inability to follow up (geographic relocation, etc.).
- •Active systemic infection including any gynecologic infection, untreated Urinary Tract Infection (UTI) or tissue necrosis.
- •History of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical).
- •Prior or currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area.
- •Subject has taken systemic steroids (within the last month, steroid inhalers OK), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
- •Systemic connective tissue disease (e.g. scleroderma, Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatic, lupus)
- •Chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
- •Poorly controlled diabetes mellitus (DM), as indicated by Hemoglobin A1c > 9
- •Those requiring concomitant rectopexy
- •Subject is not able to conform to steep Trendelenburg position
- •Known sensitivity to polypropylene
- •History of prior prolapse repair utilizing vaginal or abdominal mesh
- •Planned vaginal mesh attachment placed transvaginally
- •History of diverticulitis
结局指标
主要结局
Time to complete vaginal graft attachment
时间窗: Day 1
To determine if delayed-absorbable barbed suture (2-0 V-Loc) produces a decrease in the time to achieve vaginal mesh attachment during minimally invasive SCP (with or without concomitant total hysterectomy) compared to delayed- absorbable polydioxanone (2-0 PDS) interrupted suture - time (in minutes and seconds)
次要结局
- Composite success rate(Year 1)
- Vaginal mesh exposure at 1 year(Year 1)
- Surgeon satisfaction with technique(Day 1)
- Patient change in quality of life, symptom bother, and sexual functioning - (PFDI-20) Pelvic Floor Distress Inventory(Year 1)
- Patient change in quality of life, symptom bother, and sexual functioning - (PISQ-sf) Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form(Year 1)
- Adverse outcome scores(Week 6)
- Patient change in quality of life, symptom bother, and sexual functioning - (PFIQ-sf7) Pelvic Floor Impact Questionnaire Short form(Year 1)