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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral High Uterosacral Ligament Suspension | Experimental | Participants undergo unilateral high uterosacral ligament suspension following vaginal hysterectomy for pelvic organ prolapse. |
|
| Bilateral High Uterosacral Ligament Suspension | Experimental | Participants undergo bilateral high uterosacral ligament suspension following vaginal hysterectomy for pelvic organ prolapse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Uterosacral Ligament Suspension | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical Success Rate | 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. | 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Prolapse Recurrence Rate | Recurrence of pelvic organ prolapse defined as descent of any vaginal compartment to or beyond the hymen during follow-up. | 12 months postoperatively |
| Operative Time | Duration of surgery measured from incision to completion of the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| abdurrahman sengi, MD | Saglik Bilimleri University Gazi Yasargil Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saglik Bilimleri University Gazi Yasargil Training and Research Hospital | Diyarbakır | 21000 | Turkey (Türkiye) |
No plan to share individual participant data.
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Participants will be assigned to one of two groups undergoing either unilateral or bilateral high uterosacral ligament suspension following vaginal hysterectomy.
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This is an open-label study; neither participants nor investigators are blinded to the surgical technique performed.
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|
| Intraoperative |
| Intraoperative Complications | Occurrence of complications during surgery, including bleeding, ureteral injury, or other surgical complications. | During surgery |
| Postoperative Complications | Complications occurring after surgery, including infection, pain, or need for reoperation. | Up to 30 days postoperatively |
| Functional Outcomes | Patient-reported outcomes including urinary, bowel, and sexual function assessed using validated questionnaires. | 6 and 12 months postoperatively |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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