May-Thurner Syndrome Clinical Trial
— ESIPVOfficial title:
Evaluation of the Efficacy and Safety of Surgical and Endovascular Interventions on the Pelvic Veins in Pelvic Venous Disorders
Verified date | October 2023 |
Source | Pirogov Russian National Research Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study includes a retrospective and prospective study will enroll patients with pelvic venous disorders who have undergone pelvic vein surgery and endovascular interventions. Three groups of patients will be formed. The first will include patients who underwent open retroperitoneal resection of the gonadal veins and endoscopic trans- and retroperitoneal resection of the gonadal veins. The second group will include patients who underwent embolization of the gonadal veins with coils, the third - patients who underwent stenting of the common iliac veins, or stenting of the iliac veins in combination with embolization of the gonadic veins with coils. Evaluation of the effectiveness and safety of interventions on the pelvic veins will be carried out by assessing the effect of the intervention on pelvic pain, morphological and functional state of the pelvic veins. The assessment of the safety of interventions on the pelvic veins will be carried out by assessing the severity of post-procedural pain, the frequency of complications of operations on the pelvic veins, and complications of anesthesia. In addition, the duration of pelvic vein interventions will be compared with the length of time the patient is in hospital. Based on the data obtained, an algorithm will be proposed for determining the choice of the method of interventions on the pelvic veins in patients with pelvic venous disorders.
Status | Completed |
Enrollment | 400 |
Est. completion date | February 11, 2023 |
Est. primary completion date | January 30, 2023 |
Accepts healthy volunteers | |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - the presence of pelvic venous disorder symptoms and signs (chronic pelvic pain, dyspareunia, discomfort/heaviness in the hypogastrium); - reflux in the gonadal, parametrial, uterine veins, according to duplex ultrasound scanning and ovarian venography or multislice computed venography (MSCV); - narrowing of the lumen of the left CIV greater than 50% with imaging of collateral veins by the radiological contrast studies Exclusion Criteria: - combined surgery on the veins and pelvic organs; comorbidities with ??? |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Department of Faculty Surgery ?1 | Moscow |
Lead Sponsor | Collaborator |
---|---|
Pirogov Russian National Research Medical University |
Russian Federation,
Lakhanpal G, Kennedy R, Lakhanpal S, Sulakvelidze L, Pappas PJ. Pelvic venous insufficiency secondary to iliac vein stenosis and ovarian vein reflux treated with iliac vein stenting alone. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1193-1198. doi: 1 — View Citation
Maratto S, Khilnani NM, Winokur RS. Clinical Presentation, Patient Assessment, Anatomy, Pathophysiology, and Imaging of Pelvic Venous Disease. Semin Intervent Radiol. 2021 Jun;38(2):233-238. doi: 10.1055/s-0041-1729745. Epub 2021 Jun 3. — View Citation
Meissner MH, Khilnani NM, Labropoulos N, Gasparis AP, Gibson K, Greiner M, Learman LA, Atashroo D, Lurie F, Passman MA, Basile A, Lazarshvilli Z, Lohr J, Kim MD, Nicolini PH, Pabon-Ramos WM, Rosenblatt M. The Symptoms-Varices-Pathophysiology classificatio — View Citation
Possover M, Khazali S, Fazel A. Pelvic congestion syndrome and May-Thurner syndrome as causes for chronic pelvic pain syndrome: neuropelveological diagnosis and corresponding therapeutic options. Facts Views Vis Obgyn. 2021 Jun;13(2):141-148. doi: 10.5205 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Complications of anesthesia | Hematoma, vascular damage, pulmonary complications. | 1 and 5 days after the intervention on the pelvic veins | |
Other | Wound infectious complications | It was assessed visually, on the basis of examination and palpation of the puncture point of the main vein or postoperative wounds. | 5 days after the intervention on the pelvic veins | |
Primary | Change in the severity of pelvic pain | The visual analogue scale is a line 10 cm long. Each centimeter corresponds to 1 point: 0 points - no pain, 10 points - maximum pain. Higher scores on the scale correspond to poorer results. | At baseline and 12 months after pelvic vein intervention. | |
Secondary | Change in the diameter of the pelvic veins | The diameter of the pelvic veins was measured using duplex ultrasound. | At baseline and 12 months after pelvic vein intervention. | |
Secondary | Change in the duration of pelvic venous reflux | Pelvic venous reflux was measured using duplex ultrasound. Reflux duration of more than 1 s was considered pathological. | At baseline and 12 months after pelvic vein intervention. | |
Secondary | Postprocedural pain | The visual analogue scale is a line 10 cm long. Each centimeter corresponds to 1 point: 0 points - no pain, 10 points - maximum pain. Higher scores on the scale correspond to poorer results. | 1 day, 5 days, 1 and 12 months after the intervention on the pelvic veins. | |
Secondary | Pelvic vein thrombosis | Pelvic vein thrombosis was detected using duplex ultrasound. | 1 and 5 days after the intervention on the pelvic veins |
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