Pelvic Organ Prolapse Clinical Trial
Official title:
Is Absorbable Suture Non-Inferior to Permanent Suture in Sacrospinous Ligament Suspension? A Randomized Controlled Trial
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05422209 -
The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair.
|
N/A | |
Active, not recruiting |
NCT05420831 -
Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment
|
N/A | |
Completed |
NCT05493735 -
Lidocaine for Pessary Check Pain Reduction
|
Phase 3 | |
Completed |
NCT06126328 -
Materna Prep Study Phase II
|
Phase 2 | |
Recruiting |
NCT05542836 -
EVeRLAST 2-Year Follow-Up
|
||
Recruiting |
NCT05918367 -
Multicenter Ventral Mesh Rectopexy Registry Collaborative
|
||
Recruiting |
NCT04172272 -
The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures
|
N/A | |
Recruiting |
NCT04807920 -
BOTOX® at the Time of Prolapse Surgery for OAB
|
Phase 4 | |
Completed |
NCT06268782 -
The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women
|
N/A | |
Recruiting |
NCT03146195 -
The 3D Reconstruction Research of Pelvic Organ Prolapse Disease
|
N/A | |
Recruiting |
NCT02919852 -
Laparoscopic Retrovesical Colpopectinopexia
|
N/A | |
Completed |
NCT02925585 -
Vaginal Tactile Imaging for Pelvic Floor Prolapse
|
||
Not yet recruiting |
NCT02536001 -
Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes
|
N/A | |
Recruiting |
NCT02113969 -
Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
|
N/A | |
Completed |
NCT02383199 -
Polypropylene Mesh in Prolapse Surgery
|
N/A | |
Terminated |
NCT01673360 -
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
|
N/A | |
Withdrawn |
NCT01530191 -
Factors Affecting Perioperative Outcomes
|
N/A | |
Completed |
NCT01842464 -
Sacro-Spinous Ligaments Anterior Apical Anchoring
|
N/A | |
Completed |
NCT01320631 -
Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction
|
N/A | |
Completed |
NCT00581412 -
Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates
|
N/A |