Clinical trial NCT05076448: The Efficacy and Safety of Interventions on the Pelvic Veins in Pelvic Venous Disorders
Official title: Evaluation of the Efficacy and Safety of Surgical and Endovascular Interventions on the Pelvic Veins in Pelvic Venous Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: This study includes a retrospective and prospective study and will include patients with pelvic venous disorders (ovarian venous insufficiency, compression stenosis of the left or right common iliac vein) who underwent surgical and endovascular interventions on the pelvic veins during 2000-2022. The database of the local system "Interin" of the First City Hospital of Moscow (Russia) will be used, into which all information about patients with pelvic venous diseases during 2000-2021 was entered.

In this study, the pelvic veins included the gonadal, parametric, uterine, common, external and internal iliac veins.

Indications for intervention on the gonadal veins are symptoms and signs of pelvic venous disorder (pelvic pain, dyspareunia, heaviness in the hypogastric region, vulvar varicose veins) in combination with the expansion of the gonadal veins of more than 5 mm and reflux in them for more than 1 s.

The indication for intervention on the left / right common iliac vein is the presence of compression stenosis of these veins of more than 50% in combination with symptoms and signs of pelvic venous disease.

Three groups of patients will be formed. The first will include patients with ovarian venous insufficiency, dilation of the gonadal veins of more than 10 mm and reflux along them for more than 1 s, who underwent open retroperitoneal resection and endoscopic trans- and retroperitoneal resection of the gonadal veins.

The second group will include patients with ovarian venous insufficiency, dilatation of the gonadal veins less than 10 mm and pelvic venous reflux for more than 1 s, who have undergone embolization of the gonadal veins with coils.

The third will include patients with a combination of May-Thurner-Cockett syndrome and pelvic congestion syndrome who have stenting of the common iliac veins, or stenting of the iliac veins in combination with embolization of the gonadal 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. A visual analogue scale will be used to assess the dynamics of pelvic pain after gonadal and iliac vein interventions.

The assessment of the morphological and functional state will be carried out using the results of transabdominal and transvaginal duplex ultrasound (diameter of the pelvic veins, linear blood flow velocity through them, the presence of reflux in these veins and its duration).

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.

Postoperative / Postprocedural pain was assessed using a visual analogue scale.

Complications of gonadal and iliac vein interventions were assessed within 1-30 days after surgery. Complications of gonadal vein resection included:

1. Wound infectious complications;
2. Thrombosis of non-targeted pelvic veins (parametric, uterine, internal iliac veins);
3. Bleeding with the formation of a retroperitoneal hematoma after surgery;
4. Massive bleeding during surgery;
5. Intestinal paresis (ileus).

Complications of gonadal vein embolization with coils included:

1. Hematoma / bleeding at the access point;
2. Thrombosis of non-targeted pelvic veins (parametric, uterine, internal iliac veins);
3. Postembolization syndrome;
4. Protrusion of spirals;
5. Migration of spirals;
6. Allergic reactions to contrast agent or nickel.

Complications of stenting of the common iliac vein included:

1. Hematoma / bleeding at the access point;
2. Stent thrombosis;
3. Migration of the stent;
4. Perforation of the iliac veins or inferior vena cava. In addition, the duration of pelvic vein interventions will be compared with the length of time the patient is in hospital.

ased on this study of data, objective information will be obtained on the effectiveness and safety of interventions on the gonadal and iliac veins, and an algorithm will be proposed for determining the choice of the method of interventions on the pelvic veins in patients with pelvic venous disorders.

Eligibility criteria: 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 СРР

Primary outcomes:
measure: Change in the severity of pelvic pain
timeFrame: At baseline and 12 months after pelvic vein intervention.
Secondary outcomes:
measure: Change in the diameter of the pelvic veins
timeFrame: At baseline and 12 months after pelvic vein intervention.
measure: Change in the duration of pelvic venous reflux
timeFrame: At baseline and 12 months after pelvic vein intervention.
measure: Postprocedural pain
timeFrame: 1 day, 5 days, 1 and 12 months after the intervention on the pelvic veins.
measure: Pelvic vein thrombosis
timeFrame: 1 and 5 days after the intervention on the pelvic veins
Other outcomes:
measure: Complications of anesthesia
timeFrame: 1 and 5 days after the intervention on the pelvic veins
measure: Wound infectious complications
timeFrame: 5 days after the intervention on the pelvic veins
Locations:
city: Moscow
country: Russian Federation
facility: Department of Faculty Surgery №1
Study officials:
affiliation: Pirogov Russian National Research Medical University
name: Natalia V Koroleva, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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 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.
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: 10.52054/FVVO.13.2.019.