Barbed-suture Efficiency Study for Sacrocolpopexy (NCT05760794) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Barbed-suture Efficiency Study for Sacrocolpopexy
United States52 participantsStarted 2023-06-21
Plain-language 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.
Who can participate
Age range21 Years – 80 Years
SexFEMALE
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Inclusion Criteria:
* Age ≥21
* 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, polymyositi…