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Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension

Primary Purpose

Pelvic Organ Prolapse, Uterovaginal Prolapse, Vaginal Vault Prolapse

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Absorbable Suture and Permanent Suture
Sponsored by
Atlantic Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Sacrospinous Ligament Suspension, Permanent Suture, Absorbable Suture, Efficacy, Suture-related Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 Females Patients of Atlantic Urogynecology Associates undergoing sacrospinous ligament suspension procedure at Morristown and Overlook Medical Centers Exclusion Criteria: Patients who did not undergo sacrospinous ligament suspension procedure based on surgeon's intraoperative decision Patients with current gynecologic malignancies Patients with history of pelvic radiation Patients with history of prolapse repair surgery

Sites / Locations

  • Atlantic Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Absorbable Suture

Permanent Suture

Arm Description

Absorbable suture for sacrospinous ligament suspension

Permanent suture for sacrospinous ligament suspension

Outcomes

Primary Outcome Measures

Pelvic Organ Prolapse Quantification (POP-Q) exam Point C
Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. A provider who is blinded to the type of suture used will conduct postop POPQ exam.

Secondary Outcome Measures

Prolapse Recurrence
Defined as: Prolapse symptoms reported by patient, Prolapse beyond the hymen on examination in any compartment , Apical prolapse ≥ ½ TVL, Reoperation or pessary use for prolapse during the study period
PGI-I
patient's global impression of symptom improvement
Suture-related Complications
presence of abnormal vaginal discharge, vaginal spotting, post-coital spotting, dyspareunia, if they can feel sutures. On the physical exam, patients will be evaluated for apical granulation tissue, and apical suture exposure.

Full Information

First Posted
January 8, 2023
Last Updated
July 20, 2023
Sponsor
Atlantic Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05688059
Brief Title
Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension
Official Title
Is Absorbable Suture Non-Inferior to Permanent Suture in Sacrospinous Ligament Suspension? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlantic Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Sacrospinous ligament suspension (SSLS) was first described in 1958. It is commonly performed for correction of apical prolapse. A combination of delayed absorbable and/or permanent sutures are commonly used for the procedure. When permanent sutures are used, risk of suture-related complications is present and patients may require suture removal. In available literature, there is limited data comparing the efficacy and suture-related complications when using different types of sutures. A previous randomized controlled trial demonstrated that using an absorbable suture is equally efficacious as delayed absorbable sutures in SSLS. However, there is no comparison to absorbable versus permanent suture. Our aim is to compare the absorbable suture versus permanent suture for treating pelvic organ prolapse and to compare suture-related complications. Our primary outcome is comparing POPQ point C at 12 month follow up for absorbable vs permanent suture. Participants will be randomized 1:1 to absorbable or permanent suture. Follow up will occur at 2-4 weeks, 12 weeks and 12 months after the surgery.
Detailed Description
Patient demographics, previous medical and surgical history, baseline physical exam including POP-Q will be collected from the electronic medical record following enrollment. This information will be stored in REDCap which is a secure database system. Patients will be randomized by in REDCap system with the sequence of 1:1 with blocks of 6. Patients and assessors will be blinded to the type of suture that was used. The surgeons will not be blinded. All procedures will be performed by a fellowship-trained, Female Pelvic Medicine and Reconstructive Surgery board-certified surgeon. Sacrospinous ligament suspension (SSLS) procedure with the assigned suture and any scheduled concomitant prolapse and anti-incontinence procedures will be performed. Follow up exams will occur at 2-4 weeks, 12 weeks and 12 months post-operatively. The follow up visits will include a POP-Q exam at 12 weeks and 12 months. The 12 months follow up visit will include a PGI-I questionnaire. All participants will also be assessed for any suture-related complications. 12 month POP-Q exam will be completed by one of the providers who will be blinded to the suture type. There will be no additional follow up visits for participation in the study. The follow up appointments at 2-4 weeks, 12 weeks and 12 months are the times of usually scheduled post-operative follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Uterovaginal Prolapse, Vaginal Vault Prolapse, Cystocele
Keywords
Sacrospinous Ligament Suspension, Permanent Suture, Absorbable Suture, Efficacy, Suture-related Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Absorbable Suture
Arm Type
Experimental
Arm Description
Absorbable suture for sacrospinous ligament suspension
Arm Title
Permanent Suture
Arm Type
Experimental
Arm Description
Permanent suture for sacrospinous ligament suspension
Intervention Type
Other
Intervention Name(s)
Absorbable Suture and Permanent Suture
Intervention Description
Absorbable Suture and Permanent Suture
Primary Outcome Measure Information:
Title
Pelvic Organ Prolapse Quantification (POP-Q) exam Point C
Description
Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. A provider who is blinded to the type of suture used will conduct postop POPQ exam.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Prolapse Recurrence
Description
Defined as: Prolapse symptoms reported by patient, Prolapse beyond the hymen on examination in any compartment , Apical prolapse ≥ ½ TVL, Reoperation or pessary use for prolapse during the study period
Time Frame
12 months
Title
PGI-I
Description
patient's global impression of symptom improvement
Time Frame
12 months
Title
Suture-related Complications
Description
presence of abnormal vaginal discharge, vaginal spotting, post-coital spotting, dyspareunia, if they can feel sutures. On the physical exam, patients will be evaluated for apical granulation tissue, and apical suture exposure.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 Females Patients of Atlantic Urogynecology Associates undergoing sacrospinous ligament suspension procedure at Morristown and Overlook Medical Centers Exclusion Criteria: Patients who did not undergo sacrospinous ligament suspension procedure based on surgeon's intraoperative decision Patients with current gynecologic malignancies Patients with history of pelvic radiation Patients with history of prolapse repair surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaythi Khin, DO
Phone
9739717267
Email
kaythi.khin@atlantichealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Dhariwal, MD
Organizational Affiliation
Atlantic Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaythi Khin, DO
Phone
973-971-7627
Email
kaythi.khin@atlantichealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24142054
Citation
Barber MD, Maher C. Epidemiology and outcome assessment of pelvic organ prolapse. Int Urogynecol J. 2013 Nov;24(11):1783-90. doi: 10.1007/s00192-013-2169-9.
Results Reference
background
PubMed Identifier
24807341
Citation
Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
Results Reference
background
PubMed Identifier
15808370
Citation
Beer M, Kuhn A. Surgical techniques for vault prolapse: a review of the literature. Eur J Obstet Gynecol Reprod Biol. 2005 Apr 1;119(2):144-55. doi: 10.1016/j.ejogrb.2004.06.042.
Results Reference
background
PubMed Identifier
24075365
Citation
Tseng LH, Chen I, Chang SD, Lee CL. Modern role of sacrospinous ligament fixation for pelvic organ prolapse surgery--a systemic review. Taiwan J Obstet Gynecol. 2013 Sep;52(3):311-7. doi: 10.1016/j.tjog.2012.11.002.
Results Reference
background
PubMed Identifier
29677302
Citation
Jelovsek JE, Barber MD, Brubaker L, Norton P, Gantz M, Richter HE, Weidner A, Menefee S, Schaffer J, Pugh N, Meikle S; NICHD Pelvic Floor Disorders Network. Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial. JAMA. 2018 Apr 17;319(15):1554-1565. doi: 10.1001/jama.2018.2827.
Results Reference
background
PubMed Identifier
31585239
Citation
Hamdy MA, Ahmed WAS, Taha OT, Abolill ZM, Elshahat AM, Aboelroose AA. Late suture site complications of sacrospinous ligament fixation. Eur J Obstet Gynecol Reprod Biol. 2019 Nov;242:126-130. doi: 10.1016/j.ejogrb.2019.08.024. Epub 2019 Sep 19.
Results Reference
background
Citation
Sailesh Ray, Atin Halder, Mimi Gangopadhyay, Saswati Halder, and Partha Pratim Pal.Comparison of Two Different Suture Materials for Transvaginal Sacrospinous Fixation of the Vault: A Prospective Randomized Trial. Journal of Gynecologic Surgery.Dec 2013.281-286.http://doi.org/10.1089/gyn.2012.0150
Results Reference
background
PubMed Identifier
32047968
Citation
Kowalski JT, Genadry R, Ten Eyck P, Bradley CS. A randomized controlled trial of permanent vs absorbable suture for uterosacral ligament suspension. Int Urogynecol J. 2021 Apr;32(4):785-790. doi: 10.1007/s00192-020-04244-1. Epub 2020 Feb 11.
Results Reference
background
PubMed Identifier
15902168
Citation
Luck AM, Galvin SL, Theofrastous JP. Suture erosion and wound dehiscence with permanent versus absorbable suture in reconstructive posterior vaginal surgery. Am J Obstet Gynecol. 2005 May;192(5):1626-9. doi: 10.1016/j.ajog.2004.11.029.
Results Reference
background
PubMed Identifier
24618964
Citation
Barber MD, Brubaker L, Burgio KL, Richter HE, Nygaard I, Weidner AC, Menefee SA, Lukacz ES, Norton P, Schaffer J, Nguyen JN, Borello-France D, Goode PS, Jakus-Waldman S, Spino C, Warren LK, Gantz MG, Meikle SF; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA. 2014 Mar 12;311(10):1023-34. doi: 10.1001/jama.2014.1719. Erratum In: JAMA. 2015 Jun 9;313(22):2287.
Results Reference
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Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension

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