Materiovigilance After Urinary Incontinence or Prolapse Surgery
NCT ID: NCT03052985
Last Updated: 2023-09-21
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
19000 participants
OBSERVATIONAL
2017-02-14
2033-05-01
Brief Summary
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Detailed Description
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MAIN OBJECTIVE Estimate the incidence of severe complications during or after surgery of urinary incontinence or pelvic organ prolapse in adult women depending on the type of surgery performed.
SECONDARY OBJECTIVES Estimate the incidence of severe complications after urinary incontinence or prolapse surgery as a function of time since surgery.
Compare the incidence rates of severe complications considering the type of procedure (with or without mesh, vaginal or laparoscopic, etc.), comorbidities, mesh type, surgeon experience, and surgical volume centre.
Report the health and satisfaction of operated women. Estimate the risk of revision surgery for failure or recurrence.
MAIN OUTCOME Per- and post-operative complications (less than 12 months after surgery), or late (after 12 months) severe (grade III or higher according to the Clavien-Dindo classification)
OTHER OUTCOMES Time lapse of occurrence of severe complications Surgical recovery for failure or recurrence Health and perceived improvement (OMS, EQ5D, an PGI-I questionnaires)
DESIGN Prospective multicentre cohort allowing the constitution and analysis of an observatory off surgery for genital prolapse, rectal prolapse and urinary stress incontinence in women.
INCLUSION CRITERIA
* Operated for urinary incontinence, genital prolapse, or rectal prolapse in one of the centres participating in the observatory
* 18 years old or more.
SUBJECTS NUMBER Estimated at 3000 per year during 5 years in 18 participating centres
STUDY LENGTH Duration of the inclusion period: 2 years with the initial grant from ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé, French Medicines and Healthcare Products Regulatory Agency), after new funding by ANSM 5 years of inclusion in total.
Duration of participation of subjects: 2 years with grant from ANSM, after the new funding by ANSM 10 years.
Total duration of the study: 3 years with the grant from ANSM, 15 years with the new funding.
ANALYSIS PLANNED The one-year analysis will be based on multivariate logistic regression analysis (considering confounding factors). The 10-year (or intermediate-term) analysis will use survival analysis methods to account for delays in complications: Kaplan-Meier curves; Model of Cox proportional hazards.
PERSPECTIVES The observatory should make it possible to precise the tolerance and the short- and long-term consequences of the use of these implantable devices (meshes) in pelvic organ prolapse or incontinence surgery in women and to specify the risk factors for severe complications.
The observatory will enable to make comparisons between the different types of meshes and different surgical procedures, and to identify those that may present problems.
Clinical practice recommendations may be issued as well as standards for marketing.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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urinary incontinence, pelvic organ or rectal prolapse surgery
The observatory is planned for following women after surgery for urinary incontinence, pelvic organ prolapse, or rectal prolapse whatever the type of surgery (by laparoscopy, laparotomy or vginal route) or the use of a mesh
Eligibility Criteria
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Inclusion Criteria
* 18 years old or more.
18 Years
FEMALE
No
Sponsors
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Agence Nationale de sécurité du Médicament
OTHER
Poitiers University Hospital
OTHER
Responsible Party
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Principal Investigators
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Xavier FRITEL, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Poitiers University Hospital
Locations
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Centre l'Avancée - Clinique Axium
Aix-en-Provence, , France
C.H.U. d'Angers
Angers, , France
CHRU de Besançon
Besançon, , France
Centre Hospitalier de Béthune
Béthune, , France
CHU de Bordeaux
Bordeaux, , France
CHU Caen
Caen, , France
Centre Hospitalier Camille Guérin
Châtellerault, , France
Hôpital Antoine-Béclère
Clamart, , France
Chu Estaing
Clermont-Ferrand, , France
Centre Hospitalier de Dunkerque
Dunkirk, , France
Polyclinique d'Hénin-Beaumont
Hénin-Beaumont, , France
Hopital La Rochelle- Ré- Aunis
La Rochelle, , France
CHU Lille
Lille, , France
Hôpital St Vincent De Paul
Lille, , France
CHU de Limoges
Limoges, , France
Hospices Civils de Lyon
Lyon, , France
Clinique BEAUSOLEIL
Montpellier, , France
CHRU de NANCY
Nancy, , France
CHU Nantes
Nantes, , France
CHRU Carémeau
Nîmes, , France
La Pitié-Salpêtrière
Paris, , France
Hôpital Bichat
Paris, , France
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, , France
Centre briochin d'Urologie
Plérin, , France
CHI Poissy-St-Germain
Poissy, , France
CHU de Poitiers
Poitiers, , France
CHU de Reims
Reims, , France
CHU Strasbourg
Strasbourg, , France
Hopital Foch
Suresnes, , France
Clinique UROVAR
Toulon, , France
CHU de Toulouse
Toulouse, , France
Countries
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References
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Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
Other Identifiers
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2016-A01868-43
Identifier Type: -
Identifier Source: org_study_id
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