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Barbed-suture Efficiency Study for Sacrocolpopexy

NCT ID: NCT05760794

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-21

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Prolapse; Female

Keywords

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sacrocolpopexy pelvic organ prolapse vaginal mesh attachment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Plan to enroll 52 participants with intention to treat 26 in each group - Participants will be randomized to delayed-absorbable barbed suture (2-0 V-Loc) versus delayed-absorbable interrupted suture (2-0 PDS).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Patient will be masked to their allocation and post-operative examiners will be masked at the 6 week, 6 month, and 12 month visits

Study Groups

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Non-barbed delayed absorbable suture

Participants assigned to Non-barbed delayed absorbable suture group will have Non-barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP

Group Type EXPERIMENTAL

Non-barbed delayed absorbable suture

Intervention Type PROCEDURE

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 suture

Participants assigned to Barbed delayed absorbable suture group will have Barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP

Group Type EXPERIMENTAL

Barbed delayed absorbable suture

Intervention Type PROCEDURE

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.

Interventions

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Non-barbed delayed absorbable suture

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.

Intervention Type PROCEDURE

Barbed delayed absorbable suture

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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, 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katherine L Woodburn, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5.

Reference Type BACKGROUND
PMID: 23633316 (View on PubMed)

Siddiqui NY, Grimes CL, Casiano ER, Abed HT, Jeppson PC, Olivera CK, Sanses TV, Steinberg AC, South MM, Balk EM, Sung VW; Society of Gynecologic Surgeons Systematic Review Group. Mesh sacrocolpopexy compared with native tissue vaginal repair: a systematic review and meta-analysis. Obstet Gynecol. 2015 Jan;125(1):44-55. doi: 10.1097/AOG.0000000000000570.

Reference Type BACKGROUND
PMID: 25560102 (View on PubMed)

Paraiso MF, Walters MD, Rackley RR, Melek S, Hugney C. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol. 2005 May;192(5):1752-8. doi: 10.1016/j.ajog.2004.11.051.

Reference Type BACKGROUND
PMID: 15902189 (View on PubMed)

Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008 Dec;112(6):1201-1206. doi: 10.1097/AOG.0b013e31818ce394.

Reference Type BACKGROUND
PMID: 19037026 (View on PubMed)

Matthews CA, Geller EJ, Henley BR, Kenton K, Myers EM, Dieter AA, Parnell B, Lewicky-Gaupp C, Mueller MG, Wu JM. Permanent Compared With Absorbable Suture for Vaginal Mesh Fixation During Total Hysterectomy and Sacrocolpopexy: A Randomized Controlled Trial. Obstet Gynecol. 2020 Aug;136(2):355-364. doi: 10.1097/AOG.0000000000003884.

Reference Type BACKGROUND
PMID: 32649494 (View on PubMed)

Bazzi AA, Osmundsen BC, Hagglund KH, Aslam MF. Anatomical Outcomes Based on Suturing Technique During Vaginal Mesh Attachment in Robotic Sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):105-108. doi: 10.1097/SPV.0000000000000654.

Reference Type BACKGROUND
PMID: 30807409 (View on PubMed)

Moore R, Moriarty C, Chinthakanan O, Miklos J. Laparoscopic sacrocolpopexy: operative times and efficiency in a high-volume female pelvic medicine and laparoscopic surgery practice. Int Urogynecol J. 2017 Jun;28(6):887-892. doi: 10.1007/s00192-016-3179-1. Epub 2016 Oct 20.

Reference Type BACKGROUND
PMID: 27766346 (View on PubMed)

Catanzarite T, Saha S, Pilecki MA, Kim JY, Milad MP. Longer Operative Time During Benign Laparoscopic and Robotic Hysterectomy Is Associated With Increased 30-Day Perioperative Complications. J Minim Invasive Gynecol. 2015 Sep-Oct;22(6):1049-58. doi: 10.1016/j.jmig.2015.05.022. Epub 2015 Jun 10.

Reference Type BACKGROUND
PMID: 26070725 (View on PubMed)

Childers CP, Maggard-Gibbons M. Understanding Costs of Care in the Operating Room. JAMA Surg. 2018 Apr 18;153(4):e176233. doi: 10.1001/jamasurg.2017.6233. Epub 2018 Apr 18.

Reference Type BACKGROUND
PMID: 29490366 (View on PubMed)

Crane AK, Geller EJ, Matthews CA. Trainee performance at robotic console and benchmark operative times. Int Urogynecol J. 2013 Nov;24(11):1893-7. doi: 10.1007/s00192-013-2102-2. Epub 2013 May 3.

Reference Type BACKGROUND
PMID: 23640003 (View on PubMed)

Tan-Kim J, Nager CW, Grimes CL, Luber KM, Lukacz ES, Brown HW, Ferrante KL, Dyer KY, Kirby AC, Menefee SA. A randomized trial of vaginal mesh attachment techniques for minimally invasive sacrocolpopexy. Int Urogynecol J. 2015 May;26(5):649-56. doi: 10.1007/s00192-014-2566-8. Epub 2014 Nov 25.

Reference Type BACKGROUND
PMID: 25421934 (View on PubMed)

Lowman JK, Woodman PJ, Nosti PA, Bump RC, Terry CL, Hale DS. Tobacco use is a risk factor for mesh erosion after abdominal sacral colpoperineopexy. Am J Obstet Gynecol. 2008 May;198(5):561.e1-4. doi: 10.1016/j.ajog.2008.01.048. Epub 2008 Apr 2.

Reference Type BACKGROUND
PMID: 18377864 (View on PubMed)

Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW, Norton PA, Schaffer J, Brown MB, Brubaker L; Pelvic Floor Disorders Network. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol. 2008 Dec;199(6):688.e1-5. doi: 10.1016/j.ajog.2008.07.029. Epub 2008 Oct 31.

Reference Type BACKGROUND
PMID: 18976976 (View on PubMed)

Tan-Kim J, Menefee SA, Luber KM, Nager CW, Lukacz ES. Prevalence and risk factors for mesh erosion after laparoscopic-assisted sacrocolpopexy. Int Urogynecol J. 2011 Feb;22(2):205-12. doi: 10.1007/s00192-010-1265-3. Epub 2010 Sep 15.

Reference Type BACKGROUND
PMID: 20842494 (View on PubMed)

Other Identifiers

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IRB00093867

Identifier Type: -

Identifier Source: org_study_id