Evaluation of the Efficacy and Safety of Surgical and Endovascular Interventions on the Pelvic Veins in Pelvic Venous Disorders
Conditions: Pelvic Venous Disorders, Pelvic Congestive Syndrome, May-Thurner Syndrome
Sponsor: Pirogov Russian National Research Medical University

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Single-center retrospective cohort study: «Evaluation of the Efficacy and 
Safety of Surgical and Endovascular Interventions on the Pelvic Veins in 
Pelvic Venous Disorders» 
Document Date: March 22, 2021 
Study Protocol 
 
Project summary 
Surgical and endovascular interventions on the pelvic veins in patients with pelvic venous 
disorders (PeVD) have been used for a long time. Resection and embolization of gonadal veins 
(GV) successfully relieve symptoms and signs of pelvic venous congestion in 60-100% of patients. 
At the same time, to date, there are no convincing data on the obvious advantages of any of the 
methods, no comparative studies on this problem have been carried out. Iliac vein stenting in 
patients with a combination of May-Turner syndrome and pelvic congestion syndrome is effective 
in restoring patency of the left common iliac vein. However, it is not clear whether it is necessary 
to perform simultaneous iliac vein stenting and gonadal vein embolization in such patients, or 
whether stenting alone is sufficient. 
In addition, highly conflicting data are available regarding the complication rates of various pelvic 
vein interventions. 
Aims of the study: To evaluate the efficacy and safety of surgical and endovascular interventions 
on the pelvic veins in patients with PeVD, assess complication rates after gonadal vein 
embolization (GVE) with coils, gonadal vein resection (GVR) and stenting of the common iliac 
vein using clinical, ultrasound and radiological techniques.  
Patients and methods: A total of 300 female patients with PeVD aged who underwent open 
retroperitoneal resection  of the gonadal veins and endoscopic trans- and retroperitoneal resection 
of the gonadal veins. embolization of the gonadal veins with coils and stenting of the common 
iliac veins, or stenting of the iliac veins in combination with embolization of the gonadic veins 
with coils were planned to be enrolled in the period from 2000 to 2021.  
Treatment 
Gonadal vein embolization with coils 
GVE 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 

2 
 
(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. When selecting the 
coil size, the principle of 20% coil oversizing relative to the GV diameter was used in order to 
avoid coil migration in the conductive veins and pulmonary artery. After embolization, the control 
ovarian venography was performed.  
Open retroperitoneal GVR  
The procedure was performed under general anesthesia in the reverse Trendelenburg position, on 
the back with the operating table rotating 30° to the right or left, depending on the side of the GV 
lesion. The retroperitoneal approach was employed in the left and/or right iliac region (depending 
on the side of the GV lesion) with an incision of 5 to 7 cm, the GV was mobilized for 10-12 cm 
and its tributaries were ligated. The vein was ligated at the caudal and cranial segments and 
resected. Surgical wound was sutured in layers. Drainage of the retroperitoneal space was not used. 
Transperitoneal endoscopic GVR  
The procedure was performed under general anesthesia in the reverse Trendelenburg position, on 
the back with the operating table turning 30 ° to the right or left, depending on the intervention 
side. After carbon dioxide (CO2) insufflation into the peritoneal cavity (intraabdominal pressure 
12 mm Hg), three 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 parietal peritoneum 
was dissected, the GV was mobilized over a length of 10-12 cm, the GV tributaries were ligated, 
the caudal and cranial segments of the vein were clipped or ligated, and the vessel was resected. 
The wounds were sutured, and no drainage was used.  
Retroperitoneal endoscopic GVR  
The procedure was performed under general anesthesia, and the carbon dioxide insufflation into 
the retroperitoneum (pressure 12 mm Hg) was applied using a Veress needle in a patient lying on 
the left of right side 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. Then 
one or two 5-mm instrument ports were installed. The GV was mobilized over a length of 10-12 
cm, the GV tributaries were ligated, the caudal and cranial segments of the vein were clipped, and 
the vessel was resected. The wounds were sutured, and no drainage was used. 
Stenting of the left common iliac vein 
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, 

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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. A control 
multiplanar phlebography was repeated thereafter.  
All interventions were performed in surgical clinic settings. The routine anticoagulation to prevent 
thromboembolic complications after the procedure was not prescribed. All patients used 
antiembolism compression stockings before and after the interventions. Patient mobilization after 
GVE or GVR started 2 hours after the intervention.  
Assessment of the GVE, GVR and stent placement complications 
Complications of GVE were graded according to the Society for Interventional Radiology (SIR) 
Adverse Event Classification System as follows: A - No therapy, no consequences; B - Nominal 
therapy, no consequence; includes overnight admission for observation only; C - Requires therapy, 
minor hospitalization (< 48 h); D - Requires major therapy, unplanned increase in level of care, 
prolonged hospitalization (> 48 h); E - Permanent adverse sequelae; F - Death. Minor 
complications include classes A and B, and major complications include classes C to F. 
The GVR complications were assessed in line with general surgical principles: intraoperative 
bleeding, damage to organs and tissues during surgery, ileus, wound infectious complications 
(infiltration, suppuration), venous thromboembolism (VTE). 
In addition, clinical efficacy - chronic pelvic pain (CCP) reduction or cessation, was assessed 30 
days after the intervention, and the rate of PeVD relapses in the long term was evaluated. The 
PeVD relapse was defined as the recurrence of its clinical manifestations (CPP, dyspareunia, 
discomfort or heaviness in the hypogastric area) and the detection of refluxed veins in the 
retroperitoneal space in the area of previous interventions by duplex ultrasound (DUS), or 
visualization of veins in the projection of previous GV embolization or resection by multislice 
computed venography (MSCV) or ovarian venography. 
Duration of study: September 2021 – November 2021 
Expected outcome: The use of a venoactive drug reduces the incidence and severity of PES.  
 
General information  
Protocol title: Evaluation of the Efficacy and Safety of Surgical and Endovascular Interventions 
on the Pelvic Veins in Pelvic Venous Disorders 
Sponsor/funder: No  

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Responsible for conducting the research: Sergey Gennadievich Gavrilov, MD, PhD, Professor of 
Surgery, Pirogov Russian National Research Medical University, 1 Ostrovityanova st. Moscow, 
117997, Russia; tel.: 8 (495) 434-30-83 
Departments: Savelyev University Surgical Clinic; 10/5 Leninsky prospect, Moscow, 119049, 
Russia. 
 
Rationale & background information 
Pelvic venous disease (PeVD), caused by dilation and valvular incompetence of the gonadal, 
parametrial and uterine veins, often manifests with chronic pelvic pain (CPP), coital and postcoital 
pain, and dysuria [1,2]. Main treatment goals in such patients are pelvic pain relief and recovery 
of venous outflow from the pelvic organs [3,4]. Numerous studies have shown that reduction in 
blood flow in the gonadal veins (GV) using endovascular occlusion or surgical resection is 
accompanied by a substantial relief or elimination of the PeVD symptoms and signs [5,6].  
Gonadal veins embolization (GVE) with nitinol or platinum coils is widely used in the treatment 
of PeVD [7,8]. Most authors report a high efficacy of this technique in reducing blood flow in the 
GV and relieving symptoms and signs [9,10]. Clinical practice guidelines of the Society for 
Vascular Surgery (SVS) and the American Venous Forum (AVF) consider GVE as a standard 
treatment for PeVD (grade 2B due to moderate-quality evidence) [11]. Another effective treatment 
for PeVD is gonadal veins resection (GVR) performed using open retroperitoneal or endoscopic 
approaches [12-14]. Despite the priority given to GVE with coils in clinical guidelines and 
international consensus documents [2,11], there is no clear evidence, or rather conclusive trials 
showing that GVE has a higher clinical efficacy compared to GVR. The issue is specifically about 
clinical efficacy (i.e. relief of the PeVD symptoms and signs) and not the technical success of GVE 
(occlusion of GVs and elimination of reflux in them), technique of the intervention under local 
anesthesia, or aesthetic aspects of the procedure (absence of postoperative scars). The main 
argument of GVE advocates is that GVR is a traumatic intervention requiring general anesthesia 
[15,16]. Moreover, there are many studies reporting a wide variability in the GVE outcomes, such 
as CPP relief, persistence or worsening of pain after GVE, and coil migrations and protrusions 
[16-19]. It was found that 6% to 32% of patients do not achieve significant pain relief after the 
procedure [20]. Most studies of GVE in PeVD only acknowledge the fact of complications, but do 
not investigate their causes [9,10,15,17]. To date, only few studies were performed to evaluate 
GVR in PeVD, and they provide limited data on the complications after this procedure [13, 20, 
21,22]. Therefore, it is of great interest to examine thoroughly the possible post-procedural 
complications in order to avoid treatment failures, to improve a certain therapeutic technique, or 
to abandon it altogether.  

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References 
1. Phillips D, Deipolyi AR, Hesketh RL, Midia M, Oklu R. Pelvic congestion syndrome: 
etiology of pain, diagnosis, and clinical management. J Vasc Interv Radiol. 2014; 25: 725-
33.  
2. Antignani PL, Lazarashvili Z, Monedero JL, Ezpeleta SZ, Whiteley MS, Khilnani NM, et 
al. Diagnosis and treatment of pelvic congestion syndrome: UIP consensus document. Int 
Angiol. 2019;38:265-83 
3. Guirola JA, Sanchez-Ballestin M, Sierre S, Lahuerta C, Mayoral V, De Gregorio MA. A 
Randomized trial of endovascular embolization treatment in pelvic congestion syndrome: 
fibered platinum coils versus vascular plugs with 1-year clinical outcomes. J Vasc Interv 
Radiol. 2018;29:45-53 
4. Gavrilov SG, Sazhin A, Krasavin G, Moskalenko E, Mishakina N. Comparative analysis 
of the efficacy and safety of endovascular and endoscopic interventions on the gonadal 
veins in the treatment of pelvic congestion syndrome. J Vasc Surg Venous Lymphat 
Disord. 2021;9:178-86 
5. Borghi C, Dell'Atti L. Pelvic congestion syndrome: the current state of the literature. Arch 
Gynecol Obstet. 2016;293:291-301 
6. Whiteley MS, Lewis-Shiell C, Bishop SI, Davis EL, Fernandez-Hart TJ, Diwakaret P, et 
al. Pelvic vein embolisation of gonadal and internal iliac veins can be performed safely and 
with good technical results in an ambulatory vein clinic, under local anaesthetic alone - 
Results 
from 
two 
years' 
experience. 
Phlebology. 
2018;33:575-579. 
https://doi.org/10.1177/0268355517734952  
7. Khilnani NM, Meissner MH, Learman LA, Gibson KD, Daniels JP, Winokuret RS, al. 
Research priorities in pelvic venous disorders in women: recommendations from a 
multidisciplinary research consensus panel. J Vasc Interv Radiol. 2019; 30: 781-789. 
https://doi.org/10.1016/j.jvir.2018.10.008  
8. Daniels JP, Champaneria R, Shah L, Gupta JK, Birch J, Moss JG. Effectiveness of 
embolization or sclerotherapy of pelvic veins for reducing chronic pelvic pain: a systematic 
review. 
J 
Vasc 
Interv 
Radiol. 
2016; 
27:1478-1486. 
https://doi.org/10.1016/j.jvir.2016.04.016  
9. Laborda A, Medrano J, de Blas I, Urtiaga I, Carnevale FC, de Gregorio MA. Endovascular 
treatment of pelvic congestion syndrome: visual analog scale (VAS) long-term follow-up 
clinical evaluation in 202 patients. Cardiovasc Intervent Radiol. 2013; 36: 1006-1101. 
https://doi.org/10.1007/s00270-013-0586-2  

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10. Dos Santos SJ, Holdstock JM, Harrison CC, Whiteley MS. Long-term results of 
transjugular coil embolisation for pelvic vein reflux - Results of the abolition of venous 
reflux 
at 
6-8 
years. 
Phlebology. 
2016; 
31:456-462.  
https://doi.org/10.1177/0268355515591306  
11. Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, et al. The 
care of patients with varicose veins and associated chronic venous diseases: clinical 
practice guidelines of the Society for Vascular Surgery and the American Venous Forum. 
J Vasc Surg. 2011; 53:2S-48S. https://doi.org/10.1016/j.jvs.2011.01.079  
12. Scultetus AH, Villavicencio JL, Gillespie DL, Kao TC, Rich NM. The pelvic venous 
syndromes: analysis of our experience with 57 patients. J Vasc Surg. 2002;36:881-8 
13. Kirienko AI, Gavrilov SG, Ianina AM, Turischeva OO. Results of different types of 
operations in patients with pelvic congestion syndrome. Flebologiya. 2016;10:44-9 
14. Sazhin AV, Gavrilov SG, Temirbolatov MD. Endoscopic technologies for the diagnostics 
and treatment of pelvic congestion syndrome. Flebologiya. 2017;11:146-53. 
https://doi.org/10.17116/flebo2017113146-153  
15. Monedero JL, Zubicoa Ezpeleta S, Castro Castro J, Calderon Ortiz M, Sellers Fernandez 
G. Embolization treatment of recurrent varices of pelvic origin. Phlebology 2006; 21:3-11. 
https://doi.org/10.1258%2F026835506775971108  
16. Borghi C, Dell'Atti L. Pelvic congestion syndrome: the current state of the literature. Arch 
Gynecol Obstet. 2016; 293:291-301. https://doi.org/10.1007/s00404-015-3895-7  
17. De Gregorio MA, Guirola JA, Alvarez-Arranz E, Sánchez-Ballestin M, Urbano J, Sierre 
S. Pelvic venous disorders in women due to pelvic varices: treatment by embolization: 
experience 
in 
520 
patients. 
J 
Vasc 
Interv 
Radiol. 
2020; 
31:1560-1569. 
https://doi.org/10.1016/j.jvir.2020.06.017  
18. Heredia FM, Escalona JM, Donetch GR, Hinostroza MS, Krause EA, Pareja R. Coil-eroded 
left ovarian vein presenting as chronic pelvic pain and genitofemoral nerve compression 
syndrome. 
J 
Minim 
Invasive 
Gynecol. 
2020;27:1008-1011. 
https://doi.org/10.1016/j.jmig.2019.11.008  
19. D’Amato R, Figueira Gonsalves JM, Palmero Tejera JM. Pulmonary embolism due to 
metal coil migration after treatment of pelvic varices. Arch Bronconeumol Engl Ed. 
2017;53:72. https://doi.org/10.1016/j.arbres.2016.03.012  
20. Nasser F, Cavalcante RN, Affonso BB, Messina ML, Carnevale FC, de Gregorio MA. 
Safety, efficacy, and prognostic factors in endovascular treatment of pelvic congestion 
syndrome. 
Int 
J 
Gynaecol 
Obstet. 
2014;125:65-68. 
https://doi.org/10.1016/j.ijgo.2013.10.008  

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21. Gargiulo T, Mais V, Brokaj L, Cossu E, Melis GB. Bilateral laparoscopic transperitoneal 
ligation of ovarian veins for treatment of pelvic congestion syndrome. J Am Assoc Gynecol 
Laparosc. 2003.10:501–504. doi:10.1016/S1074-3804(05)60156-9 
22. Rogers A., Beech A., Braithwaite B. Transperitoneal laparoscopic left gonadal vein 
ligation can be the right treatment option for pelvic congestion symptoms secondary to 
nutcracker syndrome. Vascular. 2007;15:238-240. doi: 10.2310/6670.2007.00034 
Study goals and objectives 
To evaluate the efficacy and safety of surgical and endovascular interventions on the pelvic veins 
in patients with PeVD, assess complication rates after gonadal vein embolization (GVE) with coils, 
gonadal vein resection (GVR) and stenting of the common iliac vein using clinical, ultrasound and 
radiological techniques. 
Study design 
This single-center retrospective cohort study included female patients with PeVD caused by 
valvular incompetence of the gonadal, parametrial or uterine veins and compression stenosis of 
the left common iliac vein, who were treated at the Savelyev University Surgical Clinic of the 
Pirogov Russian National Research Medical University in the period from 2000 to 2020. The study 
was approved by the local ethics committee of the University (N 206). Patient informed consent 
was not required due to the retrospective nature of this study.  
Inclusion criteria: 
 the presence of PeVD symptoms and signs (CPP, dyspareunia, discomfort/heaviness in the 
hypogastric area);  
 reflux in the gonadal, parametrial, uterine veins, according to DUS and ovarian venography 
(OVg) or multislice computed venography (MSCV);  
 performing gonadal vein embolization or gonadal vein resection in patients 
 performing iliac vein stenting alone or in combination with gonadal vein embolization; 
Exclusion criteria 
 pregnancy; 
 combined surgery on the veins and pelvic organs;  
 comorbidities with СРР.  
 
 
 

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Methodology 
This retrospective study 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 2000-2021. 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. 

9 
 
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. 
The study flow chart is presented in Figure 1. 
In addition, the duration of pelvic vein interventions will be compared with the length of time the 
patient is in hospital.  
Based 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 
 
 
 
 
.  
 
 
 

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Figure 1. The study flowchart. 
 
1. Clinical examination includes obtaining information on complaints and medical history data, 
physical examination, assessment of local vascular status and severity of pain (using a visual 
analogue scale). 
Clinical examination is carried out before GVE, GVR or stenting of the CIV and on days 1, 
10 and 30 after the intervention. 
2. Transabdominal and transvaginal ultrasound examination of the pelvic veins and duplex 
ultrasound examination of the veins of the lower extremities are performed before EEGV and 
on days 1, 10 and 30 after the intervention. In the absence of PES, ultrasound examinations 
are performed in the outpatient settings, otherwise, they are performed in the surgical hospital.  
3. Multislice computed tomography and multiplanar venography of the pelvic veins is performed 
in all patients prior to interventions on the pelvic veins. Repeated computed tomography is 
performed if pain persists for 10 days after EEGV. It is carried out in order to exclude 
perforation of the vein with a coil, and to detect retroperitoneal hematoma.  
4. GVE 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. 

11 
 
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. When selecting the coil size, the principle of 20% coil 
oversizing relative to the GV diameter was used in order to avoid coil migration in the 
conductive veins and pulmonary artery. After embolization, the control ovarian venography 
was performed.  
5. Open retroperitoneal GVR was performed under general anesthesia in the reverse 
Trendelenburg position, on the back with the operating table rotating 30° to the right or left, 
depending on the side of the GV lesion. The retroperitoneal approach was employed in the 
left and/or right iliac region (depending on the side of the GV lesion) with an incision of 5 to 
7 cm, the GV was mobilized for 10-12 cm and its tributaries were ligated. The vein was ligated 
at the caudal and cranial segments and resected. Surgical wound was sutured in layers. 
Drainage of the retroperitoneal space was not used. 
6. Transperitoneal endoscopic GVR  was performed under general anesthesia in the reverse 
Trendelenburg position, on the back with the operating table turning 30 ° to the right or left, 
depending on the intervention side. After carbon dioxide (CO2) insufflation into the peritoneal 
cavity (intraabdominal pressure 12 mm Hg), three 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 parietal peritoneum was dissected, the GV was mobilized over a 
length of 10-12 cm, the GV tributaries were ligated, the caudal and cranial segments of the 
vein were clipped or ligated, and the vessel was resected. The wounds were sutured, and no 
drainage was used.  
7. Retroperitoneal endoscopic GVR  was performed under general anesthesia, and the carbon 
dioxide insufflation into the retroperitoneum (pressure 12 mm Hg) was applied using a Veress 
needle in a patient lying on the left of right side 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. Then one or two 5-mm instrument ports were installed. The 
GV was mobilized over a length of 10-12 cm, the GV tributaries were ligated, the caudal and 
cranial segments of the vein were clipped, and the vessel was resected. The wounds were 
sutured, and no drainage was used. 

12 
 
8. Stenting of the left common iliac vein. 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. A control 
multiplanar phlebography was repeated thereafter. 
All interventions were performed in surgical clinic settings. The routine anticoagulation to 
prevent thromboembolic complications after the procedure was not prescribed. All patients 
used antiembolism compression stockings before and after the interventions. Patient 
mobilization after GVE or GVR started 2 hours after the intervention.  
9. Medical therapy:  
A) Anti-inflammatory and analgesic therapy: all patients receive one injection of diclofenac 
75 mg intramuscularly on the next day after interventions. 
B) Venoactive drug treatment: micronized purified flavonoid fraction (MPFF) 1000 mg once 
daily. This drug has been chosen because of its pharmacological properties, clinical effects, 
and personal experience of its use in patients with PeVD and without an indication for any 
intervention on the gonadal veins. 
C) After stenting, all patients received anticoagulant therapy for the prevention of venous 
thromboembolic events for 1 month (enoxaparin sodium or nadroparin calcium subcutaneous 
injections into the abdominal wall in a dose of 1 mg per 1 kg of body weight once daily), as 
well as antiplatelet drugs (clopidogrel 75 mg) for 3 months after intervention. 
 
All data obtained during the clinical examinations, ultrasound and radiation examinations are 
recorded in the individual case report form (CRF). 
  
References 
1. Gavrilov, S.G., Karalkin, A.V., Turischeva, O.O. Compression treatment of pelvic 
congestion syndrome. Phlebology. 33, 418-424 (2018). 

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2. Gavrilov, S.G., Lebedev, I.S. Is the endovascular embolization of tributaries of the internal 
iliac veins essential in the treatment of isolated pelvic-perineal reflux? Curr Med Res Opin. 
35, 27-31 (2019). 
3. Gavrilov, S.G., Vasilyev, A.V., Krasavin, G.V., et al. Endovascular interventions in the 
treatment of pelvic congestion syndrome caused by May-Thurner syndrome. J Vasc Surg 
Venous Lymphat Disord. 8, 1049-1057 (2020). 
4. Katsenis, K. Micronized purified flavonoid fraction (MPFF): A review of its 
pharmacological effects, therapeutic efficacy and benefits in the management of chronic 
venous insufficiency. Curr. Vasc. Pharmacol. 3, 1–9 (2005). 
5. Laborda A, Medrano J, de Blas I, Urtiaga I, Carnevale FC, de Gregorio MA. Endovascular 
treatment of pelvic congestion syndrome: visual analog scale (VAS) long-term follow-up 
clinical evaluation in 202 patients. Cardiovasc Intervent Radiol. 2013; 36: 1006-1101. 
https://doi.org/10.1007/s00270-013-0586-2  
6. Dos Santos SJ, Holdstock JM, Harrison CC, Whiteley MS. Long-term results of 
transjugular coil embolisation for pelvic vein reflux - Results of the abolition of venous 
reflux 
at 
6-8 
years. 
Phlebology. 
2016; 
31:456-462.  
https://doi.org/10.1177/0268355515591306  
7. Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, et al. The 
care of patients with varicose veins and associated chronic venous diseases: clinical 
practice guidelines of the Society for Vascular Surgery and the American Venous Forum. 
J Vasc Surg. 2011; 53:2S-48S. https://doi.org/10.1016/j.jvs.2011.01.079  
8. Scultetus AH, Villavicencio JL, Gillespie DL, Kao TC, Rich NM. The pelvic venous 
syndromes: analysis of our experience with 57 patients. J Vasc Surg. 2002;36:881-8 
9. Kirienko AI, Gavrilov SG, Ianina AM, Turischeva OO. Results of different types of 
operations in patients with pelvic congestion syndrome. Flebologiya. 2016;10:44-9 
10. Sazhin AV, Gavrilov SG, Temirbolatov MD. Endoscopic technologies for the diagnostics 
and treatment of pelvic congestion syndrome. Flebologiya. 2017;11:146-53. 
https://doi.org/10.17116/flebo2017113146-153  
11. Monedero JL, Zubicoa Ezpeleta S, Castro Castro J, Calderon Ortiz M, Sellers Fernandez 
G. Embolization treatment of recurrent varices of pelvic origin. Phlebology 2006; 21:3-11. 
https://doi.org/10.1258%2F026835506775971108  
12. Borghi C, Dell'Atti L. Pelvic congestion syndrome: the current state of the literature. Arch 
Gynecol Obstet. 2016; 293:291-301. https://doi.org/10.1007/s00404-015-3895-7  
13. De Gregorio MA, Guirola JA, Alvarez-Arranz E, Sánchez-Ballestin M, Urbano J, Sierre 
S. Pelvic venous disorders in women due to pelvic varices: treatment by embolization: 

14 
 
experience 
in 
520 
patients. 
J 
Vasc 
Interv 
Radiol. 
2020; 
31:1560-1569. 
https://doi.org/10.1016/j.jvir.2020.06.017  
14. Heredia FM, Escalona JM, Donetch GR, Hinostroza MS, Krause EA, Pareja R. Coil-eroded 
left ovarian vein presenting as chronic pelvic pain and genitofemoral nerve compression 
syndrome. 
J 
Minim 
Invasive 
Gynecol. 
2020;27:1008-1011. 
https://doi.org/10.1016/j.jmig.2019.11.008  
15. D’Amato R, Figueira Gonsalves JM, Palmero Tejera JM. Pulmonary embolism due to 
metal coil migration after treatment of pelvic varices. Arch Bronconeumol Engl Ed. 
2017;53:72. https://doi.org/10.1016/j.arbres.2016.03.012  
16. Nasser F, Cavalcante RN, Affonso BB, Messina ML, Carnevale FC, de Gregorio MA. 
Safety, efficacy, and prognostic factors in endovascular treatment of pelvic congestion 
syndrome. 
Int 
J 
Gynaecol 
Obstet. 
2014;125:65-68. 
https://doi.org/10.1016/j.ijgo.2013.10.008  
17. Gargiulo T, Mais V, Brokaj L, Cossu E, Melis GB. Bilateral laparoscopic transperitoneal 
ligation of ovarian veins for treatment of pelvic congestion syndrome. J Am Assoc Gynecol 
Laparosc. 2003.10:501–504. doi:10.1016/S1074-3804(05)60156-9 
 
Safety considerations 
Determining the frequency of side effects of surgical and endovascular interventions on the pelvic 
veins is one of the objectives of the study. Complications were recorded in the individual case 
report form. 
Follow-up 
The results of surgical and endovascular treatment were assessed in each patient on the first and 
10th days after the intervention and 1 to 12 months after the intervention on the pelvic veins. 
Data management and statistical analysis 
Statistical analysis was performed using Microsoft Excel (Microsoft Corp, USA), Statistica 10 
(StatSoft, TIBCO, USA) and VassarStats online calculator (open source online project). 
Categorical variables are presented as frequencies (%) and compared using the Chi-square test. 
Continuous variables are presented as mean ± standard deviation (SD) and were compared between 
two drug groups using the Student's t-test or the Mann-Whitney test for normally and non-normally 
distributed variables, respectively. The relationships between various factors and the development 
of postoperative complications were studied using multivariate logistic regression analysis, and its 
results are presented as odds ratios with corresponding 95% confidence interval (CI) and P values 
for the Wald test. 

15 
 
Expected outcomes of the study 
The results of the study can improve the results of treatment of patients with PeVD and the quality 
of medical care provided to this category of patients. In addition, data on the incidence of 
complications after GVE with coils and GVR in patients with PeVD will be obtained. 
Dissemination of results and publication policy 
Besides publication of the study findings in scientific journals and reports on scientific forums, it 
is planned to use these data when developing methodological guidelines of the Ministry of Health, 
and to post the results of the study on Facebook. S.G. Gavrilov has principal role in preparing 
publications; G.V. Krasavin, N.Yu. Meshakina. 
Duration of the project 
The duration of the project is 3 months. During this period, a retrospective assessment of the results 
of surgical and endovascular treatment of 300 patients with PeVD will be carried out at the above 
time points after the interventions (1 day, 10 days, 1 month and 12 months). 
Problems anticipated 
There may be problems with the availability of sufficient data in the patient's medical records. 
Patients with insufficient data will be excluded from the study. Funding problems are not expected, 
since the research is carried out within the framework of the scientific work of the University and 
does not presuppose any additional funding. 
 
Project management 
Sergey Gennadievich Gavrilov, principal investigator. 
Recruitment of patients; determining the tactics of treating patients; choosing a treatment method; 
monitoring compliance with the requirements for patients enrolment in the study, execution of 
documentation, and ethical standards. 
 
Gennady Vladimirovich Krasavin, investigator. 
Recruitment of patients; follow-up examinations of patients; execution of documentation; 
statistical analysis. 
 
Nadezhda Yurievna Mishakina, investigator. 
Recruitment of patients; follow-up examinations of patients; execution of documentation; 
statistical analysis. 
 
Ethics 

16 
 
The study was approved by the local ethics committee of the University (Protocol N 206, March 
22, 2021). Patient informed consent was not required due to the retrospective nature of this study. 
 
Budget 
The study has no special funding. The study will be carried out as part of the scientific and research 
work of the University. 
 
Other support for the project 
No funding 
 
Links to other projects 
No 
 
Curriculum Vitae of investigators 
 
Sergey Gennadievich Gavrilov, Principal investigator. 
Degree: MD, PhD 
Title: Professor 
Date of Birth: 5.03.1970 
Address: 10/5 Leninsky prospect, Moscow, Russia 
Phone mobile: +7(916) 9299947 
e-mail: gavriloffsg@mail.ru 
 
198-1994 
Medical Doctor 
Pirogov Russian National Research Medical University, 
Moscow, Russia 
1994-1999 Surgeon 
Pirogov Russian National Research Medical University, 
Moscow, Russia 
2007 
Vascular Surgeon 
Russian Academy of Postgraduate Education, Moscow, 
Russia 
2008 
PhD 
Pirogov Russian National Research Medical University, 
Moscow, Russia 
 
Experience in Clinical Trials: 

17 
 
Year 
Study 
Phase 
Therapeutic Indication 
Position 
2002 
III 
Chronic Venous Disease  
Sub-Investigator 
2004 
III 
Chronic Venous Disease 
Principal 
Investigator 
 
Publications: 
Total: 134 
 
Recent: 
1. Gavrilov SG, Vassilieva GY, Vasilev IM, Grishenkova AS. The role of vasoactive 
neuropeptides in the genesis of venous pelvic pain: A review. Phlebology. 2020;35(1):4-9 
doi: 10.1177/0268355519855598 
2. Gavrilov SG, Vasilieva GY, Vasiliev IM, Efremova OI. Calcitonin Gene-Related Peptide 
and Substance P As Predictors of Venous Pelvic Pain. Acta Naturae. 2019;11(4):88-92. 
doi: 10.32607/20758251-2019-11-4-88-92. 
3. Gavrilov SG, Vasilyev AV, Krasavin GV, Moskalenko YP, Mishakina NY. Endovascular 
interventions in the treatment of pelvic congestion syndrome caused by May-Thurner 
syndrome. J Vasc Surg Venous Lymphat Disord. 2020;8(6): 1049-1057. doi: 
10.1016/j.jvsv.2020.02.012 
4. Gavrilov SG, Moskalenko YP. Does pelvic congestion syndrome influence symptoms of 
chronic venous disease of the lower extremities? Eur J Obstet Gynecol Reprod Biol. 
2019;243:83-86 doi: 10.1016/j.ejogrb.2019.10.025 
5. Gavrilov SG, Efremova OI. Surgical aspects of venous pelvic pain treatment. Curr Med 
Res Opin. 2019;35(11):1983-1989. doi: 10.1080/03007995.2019.1631059 
6. Gavrilov SG, Lebedev IS. Is the endovascular embolization of tributaries of the internal 
iliac veins essential in the treatment of isolated pelvic-perineal reflux? Curr Med Res Opin. 
2019;35(1):27-31. doi: 10.1080/03007995.2018.1498781 
7. Gavrilov SG, Moskalenko YP, Karalkin AV. Effectiveness and safety of micronized 
purified flavonoid fraction for the treatment of concomitant varicose veins of the pelvis 
and 
lower 
extremities. 
Curr 
Med 
Res 
Opin. 
2019;35(6):1019-1026. 
doi: 
10.1080/03007995.2018.1552043 
8. Gavrilov, S.G., Karalkin, A.V., Turischeva, O.O. Compression treatment of pelvic 
congestion 
syndrome. 
Phlebology. 
2018; 
33(6): 
418-424. 
doi: 
10.1177/0268355517717424 

18 
 
9. Gavrilov S.G., Turischeva O.O. Conservative treatment of pelvic congestion syndrome: 
indications and opportunities. Curr Med Res Opin. 2017;33(6):1099-1103. doi: 
10.1080/03007995.2017.1302414 
10. Gavrilov S.G. Vulvar varicosities: Diagnosis, treatment, and prevention. International 
Journal of Women's Health. 2017; 9:463-475. doi: 10.2147/IJWH.S126165. 
 
Gennady Vladimirovich Krasavin, investigator. 
Degree: MD 
Title: Surgeon 
Date of Birth: 11.10.1980 
Address: 10/5 Leninsky prospect, Moscow, Russia 
Phone mobile: +7(915)9919555 
e-mail: gkrasavin@mail.ru 
 
Education 
2004 
Medical Doctor 
Pirogov Russian National Research Medical University 
2004-2006 Surgery (residency) 
Russian State Medical University 
 
2007 
Vascular surgery course Pirogov Russian National Research Medical University 
 
Clinical research experience: no 
Publications: 
Total: 6 
 
Recent: 
1. Gavrilov SG, Vasilyev AV, Krasavin GV, Moskalenko YP, Mishakina NY. Endovascular 
interventions in the treatment of pelvic congestion syndrome caused by May-Thurner 
syndrome. J Vasc Surg Venous Lymphat Disord. 2020;8(6): 1049-1057. doi: 30:S2213-
333X(20)30111-6 
2. Gavrilov SG, Sazhin AV, Krasavin GV, Efremova OI, Mishakina NYu. Endovascular 
Embolization in the Treatment of Venous Pelvic Pain. Flebologiya. 2020;14(2):149–154. (In 
Russ.) doi:10.17116/flebo202014021149 
3. Gavrilov SG, Maslennikov MA, Moskalenko EP, Krasavin GV. First Experience in 
Endovascular Stenting in Patients with Both May-Thurner and Pelvic Congestion Syndromes. 
Flebologiya. 
Journal 
of 
Venous 
Disorders. 
2019;13(3):196-201. 
doi: 
10.17116/flebo201913031196 

19 
 
 
Languages: Russian (native), English 
 
Nadezhda Yurievna Mishakina, investigator. 
Degree: MD 
Title: Surgeon, Ultrasound investigation 
Date of Birth: 8.06. 1980 
Address: 10/5 Leninsky prospect, Moscow, Russia 
Phone mobile: +7(916)3490739 
e-mail: mishakina.78@mail.ru  
 
Education 
2004 
Medical Doctor 
Pirogov Russian National Research Medical 
University 
2004-2006 Surgery (residency) 
Pirogov Russian National Research Medical 
University 
2007 
Vascular surgery course 
Pirogov Russian National Research Medical 
University 
2009 
Ultrasound investigation 
(Post-Graduate education) 
RUDN University 
 
Clinical research experience: no 
Publications: 
Total: 8 
 
Recent: 
1. Gavrilov SG, Sazhin AV, Krasavin GV, Efremova OI, Mishakina NYu. Endovascular 
Embolization in the Treatment of Venous Pelvic Pain. Flebologiya. 2020;14(2):149–154. (In 
Russ.) doi:10.17116/flebo202014021149 
2. Gavrilov SG, Vasilyev AV, Krasavin GV, Endovascular interventions in the treatment of 
pelvic congestion syndrome caused by May-Thurner syndrome. J Vasc Surg Venous Lymphat 
Disord. 2020;8(6): 1049-1057. doi: 30:S2213-333X(20)30111-6 
 
Languages: Russian (native), English 
 

20 
 
 
Other research activities of the investigators 
The principal investigator does not participate in other projects. 
 
Financing and insurance 
The study has no sponsors or special funding. Insurance of doctors and patients is carried out on 
the general principles of compulsory medical insurance in Russia.