The Efficacy and Safety of Interventions on the Pelvic Veins in Pelvic Venous Disorders

NCT05076448 | Completed

• 1 other identifier: 012012548111
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Venous Disorders; Pelvic Congestive Syndrome; May-Thurner Syndrome

Keywords

Pelvic Venous Disorders; Pelvic Pain; Gonadal Veins Resection; Gonadal veins Embolization; Iliac vein stenting; Complications of pelvic vein interventions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in the diameter of the pelvic veins

  At baseline and 12 months after pelvic vein intervention.

• Change in the duration of pelvic venous reflux

  At baseline and 12 months after pelvic vein intervention.

• Postprocedural pain

  1 day, 5 days, 1 and 12 months after the intervention on the pelvic veins.

• Pelvic vein thrombosis

  1 and 5 days after the intervention on the pelvic veins

Other Outcomes (2)

• Complications of anesthesia

  1 and 5 days after the intervention on the pelvic veins

• Wound infectious complications

  5 days after the intervention on the pelvic veins

Study Arms (3)

1

Gonadal veins resection This group includes patients who underwent open retroperitoneal resection of the gonadal veins, endoscopic transperitoneal and retroperitoneal resection of the gonadal veins.

Procedure: Gonadal veins resection

2

Gonadal veins embolozation This group includes patients who underwent embolization of the gonadal veins with coils.

Procedure: Gonadal vein embolization with coils

3

Stenting of the common iliac vein with or without gonadal veins embolization This group includes patients who underwent isolated iliac vein stenting or iliac vein stenting combined with gonadal vein embolization.

Procedure: Endovascular stenting of the common iliac vein (CIV)

Interventions

Gonadal veins resection PROCEDURE

Gonadal veins resection (GVR) was performed open, transperitoneal and retroperitoneal endoscopic methods under general anesthesia. Open GVR was performed in the Trendelenburg position, on the back with the operating table rotating 30° The retroperitoneal approach was employed in the left and/or right iliac region. The GV was mobilized for 10-12 cm and the vein was resected.. Transperitoneal GVR was performed with 3 ports were placed: one 10-mm port in the umbilical region, one 5-mm port in the left or right iliac region, and one 5-mm port 5 cm below the umbilicus. The GV was mobilized over a length of 10-12 cm and the vessel was resected. Retroperitoneal GVR was performed with the patient in a lateral position and in the reverse Trendelenburg position. A 10-mm camera port was installed in the lumbar region between the posterior superior iliac spine and the lower edge of the XII rib. The GV was mobilized over a length of 10-12 cm and the vessel was resected.

1

Gonadal vein embolization with coils PROCEDURE

Procedure was performed under local anesthesia with 5.0-10.0 mL of 0.5% lidocaine solution with a patient under intravenous sedation. For the left GV embolization, the transfemoral approach was used, while for the right or both GV embolization, the transjugular approach was used. The vein puncture was performed under ultrasound guidance. The 5F multipurpose angiographic catheters (Cordis; USA), standard 'moving core' J .035" guidewire, and an angled hydrophilic guidewire (Radiofocus; Terumo Corp., Japan) were used. For the GV occlusion, the pushable 0.035" standard stainless steel coils (Gianturco; William Cook, Bjæverskov, Denmark) and 0.035" coils made of Inconel with interwoven long collagen fibrils (MReye; Cook Medical Inc., Bloomington, USA) were used. The diameter of coils was 8-12 mm, and the length was 10-20 cm.

2

Endovascular stenting of the common iliac vein (CIV) PROCEDURE

After providing local anesthesia, the left common femoral vein was punctured, a 0.035" guidewire was inserted into the inferior vena cava (IVC), and then a 10F introducer was installed. A balloon catheter was introduced over the guidewire in the left CIV (XXL balloon, Boston Scientific, diameter 14-18, length 40-60 mm), and double balloon dilation of the vessel was performed with a pressure of 6-8 atm. Then, a delivery system was advanced to the area of stenosis in the left CIV, and stent was deployed at the level of confluence of the left CIV and inferior vena cava (IVC) or with a protrusion in the IVC of no more than 1 cm. For better fixation of stent in the venous lumen and prevention of its displacements and migration, a balloon post-dilatation of the stented vessel was performed. In case of residual stenosis, the balloon angioplasty was performed.

3

Eligibility Criteria

• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This single-center retrospective cohort study included female patients with pelvic venous disorders caused by valvular incompetence of the gonadal, parametrial and uterine veins and May-Thurner syndrome, who were treated at the Savelyev University Surgical Clinic of the Pirogov Russian National Research Medical University in the period from 2000 to 2021.

You may qualify if:

• 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

You may not qualify if:

• combined surgery on the veins and pelvic organs; comorbidities with СРР

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Department of Faculty Surgery №1

Moscow, 119049, Russia

Location

Related Publications (4)

• 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: 10.1016/j.jvsv.2021.03.006. Epub 2021 Mar 18.

  PMID: 33746048 RESULT

• 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.

  PMID: 34108811 RESULT

• 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 classification of pelvic venous disorders: A report of the American Vein & Lymphatic Society International Working Group on Pelvic Venous Disorders. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3):568-584. doi: 10.1016/j.jvsv.2020.12.084. Epub 2021 Jan 30.

  PMID: 33529720 RESULT

• 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: 10.52054/FVVO.13.2.019.

  PMID: 34184843 RESULT

MeSH Terms

Conditions

May-Thurner Syndrome; Pelvic Pain

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Peripheral Vascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Natalia V Koroleva, PhD

  Pirogov Russian National Research Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 13, 2021
• Study Start: September 30, 2014
• Primary Completion: January 30, 2023
• Study Completion: February 11, 2023
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

RU (1)