Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507267
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-24
Brief Title:
Pain and Clinical Reflections in Pelvic Congestion Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pain and Clinical Reflections in Pelvic Congestion Syndrome
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 multifactorialGnRH 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:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None