Cystocele, Pelvic Organ Prolapse, Uterovaginal Prolapse, Vaginal Vault Prolapse
Conditions
Keywords
Sacrospinous Ligament Suspension, Permanent Suture, Absorbable Suture, Efficacy, Suture-related Complications
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.
Interventions
OTHERAbsorbable Suture and Permanent Suture
Absorbable Suture and Permanent Suture
Sponsors
Atlantic Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Organ Prolapse Quantification (POP-Q) exam Point C | 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Prolapse Recurrence | 12 months | 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 | 12 months | patient's global impression of symptom improvement |
| Suture-related Complications | 12 months | 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. |
Countries
United States
Outcome results
None listed