BEST: Barbed-suture Efficiency Study for Sacrocolpopexy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prolapse; Female
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Time to complete vaginal graft attachment
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Time to complete vaginal graft attachment
Time Frame: 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)
Secondary Outcomes
- 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)