Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization

NCT ID: NCT04461860

Last Updated: 2020-07-08

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

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-21

Study Completion Date

2021-05-31

Brief Summary

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Summary:

Main Objective: to evaluate the efficacy of pelvic gonadal vein embolization with coils in treatment of pelvic congestion syndrome Methods: retrospective study included 25 patients in the University hospital of Brest.

The Primary Outcome Measure: To evaluate (to measure) pain relief using visual analogous scale (VAS) before and after gonadal vein embolization for pelvic congestion syndrome The Secondary Outcome Measures were to assess the impact of the treatment on specific and general symptoms through a survey.

Detailed Description

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A retrospective, non-invasive monocentric study of our Hospital 10-year registry (including data on MRI angiography and Vascular Doppler Ultrasound) of patients who have already undergone coil embolization of pelvic gonadal vein in treatment of pelvic congestion syndrome. These patients will be contacted by phone to participate in the study. An information letter will be handed out and the study protocol will be explained to the patients. After obtaining their written consent, they will be asked to fill out the study's validated questionnaire at home and return it to us through pre-paid regular mail. A face to face interview with the patient will be scheduled to assess the correlation between patient's clinical symptoms and survey results. There will be no change in patient's routine follow-up care.

All physician investigators of the study are experts in their field of medicine (e.g. interventional MRI angiography, vascular disease).

Conditions

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Pelvic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical symptoms of pelvic congestion syndrome documented by Vascular Doppler ultrasound and vascular dynamic MRI
* Failed medical treatment.
* \> 18 years \< 60 years old

Exclusion Criteria

* \< 18 years old
* Under legal guardian
* Asymptomatic pelvic congestion syndrome
* Psychiatric disorder
* Endometriosis.
* Chronic pelvic disease
* Pregnancy
* Neoplasia
* Acute intermittent porphyria
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Brest

Brest, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Philippe QUEHE

Role: CONTACT

02 98 34 75 45

Facility Contacts

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Philippe QUEHE

Role: primary

Other Identifiers

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SCVPC (29BRC20.0089)

Identifier Type: -

Identifier Source: org_study_id

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