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Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders: A Randomized Controlled Trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embolization using polidocanol foam followed by N-butyl cyanoacrylate | Active Comparator | . After selective catheterization of the ovarian vein and reflux confirmation, Sclerosant foam will be prepared using 3% polidocanol (Aethoxysklerol®, Kreussler Pharma), mixed with room air in a 1:4 ratio (1 mL polidocanol to 4 mL air) using the Tessari double-syringe technique, creating a dense and stable foam. The foam will be injected slowly into the reservoir of the refluxing segment of the ovarian vein under fluoroscopic guidance to induce endothelial irritation and reduce venous flow. A total of 5-10 mL of 3% polidocanol foam will be injected per vein, adjusted based on vein diameter and reflux length. Next, N-butyl cyanoacrylate (Gluebran®️ 2) will be mixed with Lipiodol in a 1:2 to 1:3 ratio, depending on vein size and flow rate. Approximately 1-2 mL of the glue mixture will be injected per vein using a coaxial microcatheter system from distal to proximal segments. Occlusion will be confirmed by post-embolization venography." |
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| Combined Foam Sclerotherapy and Detachable Coil Embolization | Active Comparator | Patients in this group will undergo embolization using sclerosant foam followed by detachable platinum coils. Vascular access and catheterization technique will mirror Group A. After injecting polidocanol foam (as above), subsequently, detachable platinum fibered coils - specifically Interlock™ (Boston Scientific) or Concerto™ (Medtronic) - will be deployed to achieve permanent mechanical occlusion. Coil selection (diameter and length) will be based on intra-procedural vein sizing. Final occlusion will be confirmed via completion venography. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foam + N-butyl Cyanoacrylate | Other | 3% polidocanol (Aethoxysklerol®, Kreussler Pharma), mixed with room air in a 1:4 ratio (1 mL polidocanol to 4 mL air) using the Tessari double-syringe technique, creating a dense and stable foam. |
| Measure | Description | Time Frame |
|---|---|---|
| compare the clinical efficacy of ovarian vein embolization using combined foam plus N-butyl cyanoacrylate (Gluebran®️) versus combined foam plus detachable coils | 2. Symptom severity reduction, assessed by the Pelvic Venous Clinical Severity Score (PVCSS) at baseline, 3, 6, 12, and 18 months. | 18 months |
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Inclusion Criteria
Female patients aged 18 to 50 years
Clinically suspected pelvic venous disorder (PVD), presenting with chronic pelvic pain ≥ 6 months
Pelvic pain intensity ≥ 4 on a 10-point Visual Analogue Scale (VAS) at baseline
No evidence of significant venous obstruction or internal iliac insufficiency
Willingness to participate, provide written informed consent, and comply with study visits and procedures exclusion criteria
Pregnancy or planning to conceive within the next 12 months
Significant Nutcracker syndrome diagnosed by duplex / CTV / MRV
Significant May-Thurner syndrome diagnosed by duplex / CTV / MRV
Non-ovarian sources of reflux requiring intervention, including internal iliac vein insufficiency; During venography all patients will undergo selective pelvic venography prior embolization to exclude patients who have combined gonadal and internal iliac vein reflux)
History of previous pelvic vein embolization or surgical ligation
Coagulopathy, defined as:
Severe comorbidities, including:
Known allergy or hypersensitivity to:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kafr El Shaykh University | Kafr ash Shaykh | Kafrelshaykh Governorate | 33511 | Egypt |
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| ID | Term |
|---|---|
| D004659 | Enbucrilate |
| ID | Term |
|---|---|
| D003487 | Cyanoacrylates |
| D000179 | Acrylates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Combined Foam Sclerotherapy and Detachable Coil Embolization | Other | polidocanol foam (as above), subsequently, detachable platinum fibered coils - specifically Interlock™ (Boston Scientific) or Concerto™ (Medtronic) |
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| D009930 |
| Organic Chemicals |
| D009570 | Nitriles |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D014014 | Tissue Adhesives |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |