NCT Number: NCT03052985
Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse, rectal prolapse), or incontinence surgery may be source of severe complications.
This study is active but is not currently recruiting participants.
18 year and older
Female
Observational
Centre l'Avancée - Clinique Axium, Aix-en-Provence, France
RATIONAL Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse, rectal prolapse), or incontinence surgery may be source of severe complications.
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Time frame: 10 years
Grade III or more according to Clavien-Dindo classification
Time frame: 10 years
Time frame: 10 years
Number participent with new revision surgery for failure Number participent with new revision surgery for recurrence
Time frame: 10 years
Scale OMS/ ECOG Eastern Cooperative Oncology Groupone covers six values, from 0 to 5, where 0 represents a good state of health and 5 the death.
Time frame: 10 years
EQ5D is a standardised measure of health status developed
Each of the 5 dimensions comprising the EQ-5D descriptive system is divided into 5 levels of perceived problems :
Time frame: 10 years
PGI-I, Patient Global Impression of Improvement, is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.
Poitiers University Hospital
Other
Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women.
Acronym: VIGI-MESH
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