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出境医 / 临床实验 / Duplex US in Pelvic Congestion Syndrome in Females (PCS)

Duplex US in Pelvic Congestion Syndrome in Females (PCS)

Study Description
Brief Summary:
To investigate the feasibility of Duplex US in Diagnosis of Pelvic Congestion Syndrome

Condition or disease Intervention/treatment
Pelvic Pain Syndrome Device: Duplex US

Detailed Description:
  • In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientific understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, refinements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today.
  • Since anatomical venous variations in the pelvis are common, it is important to know the anatomy of these vessels for treatment planning. Imaging is critical in the evaluation of pelvic varices, both to differentiate them from other condition and also because pelvic varices may be secondary to serious underlying pathology, such as inferior vena caval obstruction, portal hypertension, increased pelvic blood flow, and vascular malformations.

Sonographic findings of pelvic congestion syndrome were dilated left ovarian vein with reversed caudal flow, presence of varicocele, dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary, and variable duplex waveform during the Valsalva's maneuver. Combined transabdominal and transvaginal sonography are potentially useful as a noninvasive screening & grading tool for determining which patients with chronic pelvic pain may benefit from selective ovarian venography and transcatheter embolization

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Duplex US in Pelvic Congestion Syndrome in Females
Estimated Study Start Date : May 10, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Duplex US in Pelvic Congestion Syndrome in females [ Time Frame: 6 months ]
    to investigate the feasibility of Duplex US in diagnosis of Pelvic Congestion Syndrome


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 7, 2019
First Posted Date May 9, 2019
Last Update Posted Date May 9, 2019
Estimated Study Start Date May 10, 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2019)
Duplex US in Pelvic Congestion Syndrome in females [ Time Frame: 6 months ]
to investigate the feasibility of Duplex US in diagnosis of Pelvic Congestion Syndrome
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Duplex US in Pelvic Congestion Syndrome in Females (PCS)
Official Title Duplex US in Pelvic Congestion Syndrome in Females
Brief Summary To investigate the feasibility of Duplex US in Diagnosis of Pelvic Congestion Syndrome
Detailed Description
  • In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientific understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, refinements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today.
  • Since anatomical venous variations in the pelvis are common, it is important to know the anatomy of these vessels for treatment planning. Imaging is critical in the evaluation of pelvic varices, both to differentiate them from other condition and also because pelvic varices may be secondary to serious underlying pathology, such as inferior vena caval obstruction, portal hypertension, increased pelvic blood flow, and vascular malformations.

Sonographic findings of pelvic congestion syndrome were dilated left ovarian vein with reversed caudal flow, presence of varicocele, dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary, and variable duplex waveform during the Valsalva's maneuver. Combined transabdominal and transvaginal sonography are potentially useful as a noninvasive screening & grading tool for determining which patients with chronic pelvic pain may benefit from selective ovarian venography and transcatheter embolization

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population females with chronic lower abdominal pain, signs and symptoms of pelvic congestion syndrome
Condition Pelvic Pain Syndrome
Intervention Device: Duplex US
Duplex US (Caliper, wave forms...)in evaluation of Pelvic Veins (namely left ovarian vein). in pelvic congestion syndrome
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 8, 2019)
25
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients with signs and symptoms of PCS

Exclusion Criteria:

  • No
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientific understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, refinements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today
Ages 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03943381
Other Study ID Numbers Duplex US in PCS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: to be shared when finished
Responsible Party Mohamed AbuDeif Sayed, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Study Chair: Hossam M Galal Assiut University, Egypt
PRS Account Assiut University
Verification Date April 2019

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