- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04461860
Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization (SCVPC)
Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization (SCVPC)
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Brest, Frankrig, 29609
- Rekruttering
- CHRU de Brest
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Kontakt:
- Philippe QUEHE
- E-mail: philippe.quehe@chu-brest.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pelvic congestion pain relief
Tidsramme: pre-embolization and 1 month post-gonadal vein embolization
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To evaluate (to measure) pain relief using visual analogous scale before and after gonadal vein embolization for pelvic congestion syndrome.
A high score means a worse outcome.
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pre-embolization and 1 month post-gonadal vein embolization
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
evaluation of specific pelvic syndrome symptoms using a self-reported questionnaire survey
Tidsramme: pre-embolization and 1 month post-gonadal vein embolization
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to assess the impact of gonadal vein embolization on specific symptoms of pelvic congestion syndrome through a self-reported questionnaire survey.
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pre-embolization and 1 month post-gonadal vein embolization
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evaluation of general pelvic syndrome symptoms using a self-reported questionnaire survey
Tidsramme: pre-embolization and 1 month post-gonadal vein embolization
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to assess the impact of gonadal vein embolization on general symptoms of pelvic congestion syndrome through a self-reported questionnaire survey.
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pre-embolization and 1 month post-gonadal vein embolization
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SCVPC (29BRC20.0089)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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Kliniske forsøg med Bækkensmerter
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Riphah International UniversityRekruttering
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Assiut UniversityTrukket tilbagePelvic Congestive SyndromeEgypten
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The Whiteley ClinicBauerfeindRekrutteringPelvic Congestive SyndromeDet Forenede Kongerige
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IRCCS Azienda Ospedaliero-Universitaria di BolognaUkendt
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Hospital de Clínicas Dr. Manuel QuintelaUniversity of the Republic, Uruguay; Centro Cardiovascular Universitario; Centro Hospitalario Pereyra RossellUkendtVenøs sygdom | Pelvic Congestive Syndrome | Bækkenvaricer
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University of Kansas Medical CenterRekrutteringBækkensmerter | Pelvic Congestive SyndromeForenede Stater
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Quiropraxia y EquilibrioUniversidad Nacional Andres BelloAfsluttetMyofascial Trigger Point Pain (MTrP)Chile
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East Carolina UniversityTrukket tilbage
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Ain Shams UniversityAktiv, ikke rekrutterendePelvic Congestive Syndrome | Ikke-trombotiske iliaca-venelæsionerEgypten
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Quiropraxia y EquilibrioIkke rekrutterer endnuMyofascial Trigger Point Pain (MTrP)Chile