Pelvic Organ Prolapse
Conditions
Keywords
Uterosacral Ligament Suspension, Vaginal Hysterectomy, Pelvic Organ Prolapse Surgery, Apical Support, Unilateral vs Bilateral
Brief summary
This study aims to compare unilateral and bilateral high uterosacral ligament suspension techniques performed following vaginal hysterectomy in patients with pelvic organ prolapse. The objective is to evaluate the effectiveness and safety of both surgical approaches in terms of anatomical outcomes and postoperative complications. The results of this study may help guide surgical decision-making in the management of pelvic organ prolapse.
Detailed description
Pelvic organ prolapse is a common condition affecting women, often requiring surgical intervention. Vaginal hysterectomy combined with high uterosacral ligament suspension is a widely used technique for apical support. However, there is ongoing debate regarding whether unilateral or bilateral suspension provides better anatomical and clinical outcomes. This study is designed as a comparative clinical study evaluating unilateral versus bilateral high uterosacral ligament suspension performed following vaginal hysterectomy. Patients undergoing surgery for pelvic organ prolapse will be included and assigned to one of the two surgical approaches according to the study design. The primary objective is to compare anatomical success rates between the two techniques. Secondary outcomes include perioperative complications, recurrence rates, and postoperative functional outcomes. The findings of this study are expected to provide evidence regarding the optimal surgical approach for uterosacral ligament suspension and contribute to improving patient outcomes in pelvic organ prolapse surgery.
Interventions
PROCEDUREHigh Uterosacral Ligament Suspension
High uterosacral ligament suspension is a surgical procedure performed following vaginal hysterectomy to provide apical support in patients with pelvic organ prolapse. In this study, the procedure is performed either unilaterally or bilaterally depending on group assignment.
Sponsors
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study; neither participants nor investigators are blinded to the surgical technique performed.
Intervention model description
Participants will be assigned to one of two groups undergoing either unilateral or bilateral high uterosacral ligament suspension following vaginal hysterectomy.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18 years and older * Diagnosis of pelvic organ prolapse requiring surgical treatment * Planned vaginal hysterectomy with high uterosacral ligament suspension * Ability to provide informed consent
Exclusion criteria
* Previous pelvic organ prolapse surgery involving apical support * Presence of pelvic malignancy * Active pelvic infection * Severe comorbidities contraindicating surgery * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anatomical Success Rate | 12 months postoperatively | Anatomical success defined as the absence of pelvic organ prolapse at or beyond the hymen, assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prolapse Recurrence Rate | 12 months postoperatively | Recurrence of pelvic organ prolapse defined as descent of any vaginal compartment to or beyond the hymen during follow-up. |
| Operative Time | Intraoperative | Duration of surgery measured from incision to completion of the procedure. |
| Intraoperative Complications | During surgery | Occurrence of complications during surgery, including bleeding, ureteral injury, or other surgical complications. |
| Postoperative Complications | Up to 30 days postoperatively | Complications occurring after surgery, including infection, pain, or need for reoperation. |
| Functional Outcomes | 6 and 12 months postoperatively | Patient-reported outcomes including urinary, bowel, and sexual function assessed using validated questionnaires. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORabdurrahman sengi, MD
Saglik Bilimleri University Gazi Yasargil Training and Research Hospital
Outcome results
None listed