Pain and Clinical Reflections in Pelvic Congestion Syndrome

NCT ID: NCT06507267

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-10

Study Completion Date

2024-09-30

Brief Summary

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Pelvic congestion syndrome (PKS) occurs as a result of dysfunction of the veins in the pelvic area. It is currently called pelvic venous disease. This definition also includes some diseases of the pelvic region such as May-Thurner and Nutcracker syndrome. Dilatation and reflux are usually observed in the para-uterine or ovarian veins. PCS is one of the important causes of chronic pelvic pain (CPA). Pain in PCS is unrelated to the menstrual cycle. PCS is frequently seen in multiparous women in the reproductive period. Pregnancy worsens the clinical condition of patients with PCS due to mechanical pressure on the pelvic region vessels in pregnant women. Although the underlying cause of PCS is thought to be hormonal factors related to progesterone and estrogen, its etiology has not been fully elucidated and is thought to be multifactorial.GnRH analogues and medroxyprogesterone, which have side effects such as menstrual irregularity, osteoporosis and weight gain, were previously used in the medical treatment of PCS. Combined oral hormonal contraceptives, vasoactive flavonoid fraction drugs, nonsteroidal anti-inflammatory (NSAID) drugs for pain relief, Gabapentin, and Amiltriptyline are still used in the treatment of PCS. In the past, traditional hysterectomy and oophorectomy were performed surgically. Laparoscopic ovarian vein ligation has been performed since the early 2000s, but its popularity has decreased due to potential complications such as retroperitoneal hematoma, ureteral injury, and thrombosis. Endovascular intervention is more preferred today due to its low complications and high success in treatment.

Detailed Description

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The study will be conducted by retrospectively scanning the files of patients diagnosed with pelvic congestion syndrome who underwent endovascular procedures with the plug method between January 2022 and March 2024 in the Cardiovascular Surgery Department of Kanuni Sultan Süleyman Training and Research Hospital. From the patients' files, age, body mass index (BMI), painful areas and painful side, medical treatments, comorbidities, onset of pain and application time for endovascular intervention, symptoms accompanying pain (feeling of heaviness in the perineum, swelling in the labia majora, dysuria, hematuria, dyspareunia) were obtained. , Postcoital pain, Dysmenorrhea, frequent urination) The position in which the pain increases, the branches consulted before endovascular intervention, and the Numerical Rating Scale-11 (NRS-11) score in the first and third months before and after the endovascular procedure for pain evaluation will be recorded on the patient follow-up form.

Numeric Rating Scale-11 (NRS-11) is an 11-point numerical scale in which patients can evaluate their pain between 0 (no pain) and 10 (the most severe pain they have ever felt in their life).

NRS-11 will be checked 3 times: before treatment, 1st month and 3rd month after treatment.

5\. The number of patients and volunteers to be included in the research, their qualifications and the reason for selection (age ranges, gender, etc.).

The study was conducted in the Cardiovascular Surgery Department of Kanuni Sultan Süleyman Training and Research Hospital, from female patients between the ages of 18-50, who had abdominopelvic pain for more than 6 months, with clinical, physical examination and symptoms, and \>6 mm in pelvic veins on transvaginal or transabdominal ultrasonography. It is planned to include 54 patients with over-dilatation.

Conditions

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Pain, Chronic Primary

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pain and Clinical Reflections in Pelvic Congestion Syndrome

Pain and Clinical Reflections in Pelvic Congestion Syndrome

Intervention Type OTHER

Pain and Clinical Reflections in Pelvic Congestion Syndrome

Interventions

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Pain and Clinical Reflections in Pelvic Congestion Syndrome

Pain and Clinical Reflections in Pelvic Congestion Syndrome

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* It is planned to include 54 female patients between the ages of 18-50,
* who have abdominopelvic pain for more than 6 months
* who have \>6 mm dilatation in the pelvic veins on transvaginal or transabdominal ultrasonography along with clinical, physical examination and symptoms.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Halil Ibrahim Altun

pain specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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halil ibrahim altun

Role: CONTACT

+905072774773

Facility Contacts

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halil ibrahim altun, specialist

Role: primary

+9005072774773

Other Identifiers

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altunibrahim

Identifier Type: -

Identifier Source: org_study_id

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