Pelvic Venous DisordersESIPVNCT05076448
The Efficacy and Safety of Interventions on the Pelvic Veins in Pelvic Venous Disorders
An observational study of Pelvic Venous Disorders and Pelvic Congestive Syndrome, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Venous Disorders, Pelvic Congestive Syndrome, May-Thurner Syndrome
- What is being tested?
- Gonadal veins resection, Gonadal vein embolization with coils and Endovascular stenting of the common iliac vein (CIV)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteRussia
- Study dates
- 30 Sep 2014to 11 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- combined surgery on the veins and pelvic organs; comorbidities with СРР
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of Surgical and Endovascular Interventions on the Pelvic Veins in Pelvic Venous Disorders
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.
Read the 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:
- Wound infectious complications;
- Thrombosis of non-targeted pelvic veins (parametric, uterine, internal iliac veins);
- Bleeding with the formation of a retroperitoneal hematoma after surgery;
- Massive bleeding during surgery;
- Intestinal paresis (ileus).
Complications of gonadal vein embolization with coils included:
- Hematoma / bleeding at the access point;
- Thrombosis of non-targeted pelvic veins (parametric, uterine, internal iliac veins);
- Postembolization syndrome;
- Protrusion of spirals;
- Migration of spirals;
- Allergic reactions to contrast agent or nickel.
Complications of stenting of the common iliac vein included:
- Hematoma / bleeding at the access point;
- Stent thrombosis;
- Migration of the stent;
- 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.
- Being tested
- Gonadal veins resection, Gonadal vein embolization with coils, Endovascular stenting of the common iliac vein (CIV)
- Keywords
- Pelvic Venous Disorders, Pelvic Pain, Gonadal Veins Resection, Gonadal veins Embolization, Iliac vein stenting, Complications of pelvic vein interventions
- Medical subject headings
- May-Thurner Syndrome, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadal veins resectionProcedure or surgery
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.
Gonadal vein embolization with coilsProcedure or surgery
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.
Endovascular stenting of the common iliac vein (CIV)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Gonadal veins resection | |
| 2 | Gonadal veins embolozation This group includes patients who underwent embolization of the gonadal veins with coils. Receives: 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. Receives: Procedure: Endovascular stenting of the common iliac vein (CIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and 12 months after pelvic vein intervention.
Secondary outcomes (4)
Change in the diameter of the pelvic veins
The diameter of the pelvic veins was measured using duplex ultrasound.
Measured: At baseline and 12 months after pelvic vein intervention.
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.
Measured: At baseline and 12 months after pelvic vein intervention.
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.
Measured: 1 day, 5 days, 1 and 12 months after the intervention on the pelvic veins.
Pelvic vein thrombosis
Pelvic vein thrombosis was detected using duplex ultrasound.
Measured: 1 and 5 days after the intervention on the pelvic veins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start30 Sep 2014
- Primary completion30 Jan 2023
- Study completion11 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pelvic Venous DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergey Gavrilov, MD, PhD, Pirogov Russian National Research Medical University
- Investigators
- Natalia V Koroleva, PhD, Study director, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076448
- Sponsor's protocol ID
- 012012548111
- Acronym
- ESIPV
- Status last verified
- Dec 2024
- First submitted
- 20 Sep 2021
- Last updated
- 31 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33746048Maratto 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.
PubMed 34108811Meissner 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.
PubMed 33529720Possover 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.
PubMed 34184843
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Surgical and Endovascular Interventions on the Pelvic Veins in Pelvic Venous Disorders
- ClinicalTrials.gov ID
- NCT05076448
- Acronym / sponsor ID
- ESIPV / 012012548111
- Keywords
- Pelvic Venous Disorders, Pelvic Pain, Gonadal Veins Resection, Gonadal veins Embolization, Iliac vein stenting, Complications of pelvic vein interventions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 30 Sep 2014 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 11 Feb 2023 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Wound infectious complications;
- Thrombosis of non-targeted pelvic veins (parametric, uterine, internal iliac veins);
- Bleeding with the formation of a retroperitoneal hematoma after surgery;
- Massive bleeding during surgery;
- Intestinal paresis (ileus).
Complications of gonadal vein embolization with coils included:
- Hematoma / bleeding at the access point;
- Thrombosis of non-targeted pelvic veins (parametric, uterine, internal iliac veins);
- Postembolization syndrome;
- Protrusion of spirals;
- Migration of spirals;
- Allergic reactions to contrast agent or nickel.
Complications of stenting of the common iliac vein included:
- Hematoma / bleeding at the access point;
- Stent thrombosis;
- Migration of the stent;
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Gonadal veins resectionGonadal veins resection This group includes patients who underwent open retroperitoneal resection of the gonadal veins, endoscopic transperitoneal and retroperitoneal resection of the gonadal veins. |
| 2 | – | Procedure: Gonadal vein embolization with coilsGonadal veins embolozation This group includes patients who underwent embolization of the gonadal veins with coils. |
| 3 | – | Procedure: Endovascular stenting of the common iliac vein (CIV)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. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- combined surgery on the veins and pelvic organs; comorbidities with СРР
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gonadal veins resectionGonadal 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. | Procedure or surgery | 1 |
| Gonadal vein embolization with coilsProcedure 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. | Procedure or surgery | 2 |
| Endovascular stenting of the common iliac vein (CIV)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. | Procedure or surgery | 3 |
Primary outcome
Change in the severity of pelvic pain
Time frame: At baseline and 12 months after pelvic vein intervention.
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.
4 secondary outcomes
Change in the diameter of the pelvic veins
Time frame: At baseline and 12 months after pelvic vein intervention.
Change in the duration of pelvic venous reflux
Time frame: At baseline and 12 months after pelvic vein intervention.
Postprocedural pain
Time frame: 1 day, 5 days, 1 and 12 months after the intervention on the pelvic veins.
Pelvic vein thrombosis
Time frame: 1 and 5 days after the intervention on the pelvic veins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Results publication: PubMed 33746048Lakhanpal 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.
- Results publication: PubMed 34108811Maratto 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.
- Results publication: PubMed 33529720Meissner 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.
- Results publication: PubMed 34184843Possover 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia V Koroleva, PhD study director
Pirogov Russian National Research Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Venous Disorders and Pelvic Congestive Syndrome, run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the severity of pelvic pain (time frame: At baseline and 12 months after pelvic vein intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05076448, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.