Barbed-suture Efficiency Study for Sacrocolpopexy

N/AActive Not RecruitingNCT05760794

Wake Forest University Health Sciences52 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Prolapse; Female

Interventions

Non-barbed delayed absorbable suturePROCEDURE

The non-barbed delayed absorbable suture group vaginal mesh attachment will be performed with 2-0 PDS (polydioxanone). The vaginal mesh will be attached with at least four interrupted sutures on the anterior vagina and posterior vagina.

Barbed delayed absorbable suturePROCEDURE

The barbed delayed absorbable suture group vaginal mesh attachment will be performed with 2-0 V-Loc. The vaginal mesh will be attached with a running V-Loc on the anterior and posterior vagina.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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, 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

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Time to complete vaginal graft attachment

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)

Time frame: Day 1

Secondary Outcomes

Composite success rate

To compare the 1-year composite success rates of minimally invasive sacrocolpopexy (SCP) between the two groups: * Anatomic success: leading edge of prolapse is at or above the hymen (POP-Q point Ba and Bp less than or equal to and vaginal apex less than 1/3 of the total vaginal length * Subjective success: patient denies symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI)-20 question 3, answering "No" or "Yes" but "Not at all" bothersome * Assessment for re-intervention or re-operation for recurrence or persistence of pelvic organ prolapse: No need for pessary use or additional surgical treatment for prolapse at any time after the initial procedure

Time frame: Year 1

Vaginal mesh exposure at 1 year

To compare the 1 year rate of vaginal mesh exposure between the two groups - Signs and symptoms of mesh exposure include vaginal or pelvic pain, vaginal discharge or bleeding, odor, recurrent infection, abscess development, dyspareunia, or pain experienced by the sexual partner. Pain is the most common presenting symptom.

Time frame: Year 1

Adverse outcome scores

To compare adverse outcomes, classified according to the Clavien-Dindo system, between the two groups - It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) - the higher the grade; the worse the complication

Time frame: Week 6

Surgeon satisfaction with technique

To compare intraoperative surgeon satisfaction with technique between the two groups - satisfaction with technique will be assessed with a 10 point visual analog scale (VAS) for ease of placement, appearance of mesh attachment, and global satisfaction with the attachment type - 0 meaning difficult and 10 meaning easy

Data from ClinicalTrials.gov

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