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Trial record 7 of 8 for:    Recruiting, Not yet recruiting, Available Studies | "Rectal Prolapse"

Materiovigilance After Urinary Incontinence or Prolapse Surgery (VIGI-MESH)

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ClinicalTrials.gov Identifier: NCT03052985
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : February 15, 2017
Sponsor:
Collaborator:
Agence Nationale de sécurité du Médicament
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Pelvic Organ Prolapse Rectal Prolapse Urinary Stress Incontinence Procedure: urinary incontinence, pelvic organ or rectal prolapse surgery

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women.
Actual Study Start Date : February 14, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: 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


Primary Outcome Measures :
  1. Incidence of severe complications [ Time Frame: 10 years ]
    Grade III or more according to Clavien-Dindo classification


Secondary Outcome Measures :
  1. 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. [ Time Frame: 10 years ]
  2. Number of annual procedures with mesh for the surgery of urinary incontinence, pelvic organ prolapse, and rectal prolapse in France. [ Time Frame: 10 years ]
  3. Exhaustivity of the current implantable medical device surveillance compared to our reinforced observatory. [ Time Frame: 10 years ]
  4. Accuracy of the surgical procedure coding compared to the title of the surgical procedures. [ Time Frame: 2 years ]
  5. Cost of surgical treatment of urinary incontinence, pelvic organ prolapse, and rectal prolapse in France. [ Time Frame: 10 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women operated for urinary incontinence, pelvic organ prolapse, or rectal prolapse in one of the centres participating in the observatory, aged 18 years old or more.
Criteria

Inclusion Criteria:

  • Operated for urinary incontinence, pelvic organ prolapse, or rectal prolapse in one of the centres participating in the observatory
  • 18 years old or more.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052985


Contacts
Contact: Lucie Merlet, CRA +33 (0)5.49.44.30.59 lucie.merlet@chu-poitiers.fr

Locations
France
CHU de Poitiers Recruiting
Poitiers, France, 86000
Contact: Xavier Fritel, PhD, MD    549443360 ext +33    xavier.fritel@outlook.fr   
Principal Investigator: Xavier Fritel, PhD, MD         
Sponsors and Collaborators
Poitiers University Hospital
Agence Nationale de sécurité du Médicament
Investigators
Principal Investigator: Xavier FRITEL, PhD, MD Poitiers University Hospital

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03052985     History of Changes
Other Study ID Numbers: 2016-A01868-43
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Poitiers University Hospital:
medical devices (meshes)
surgery

Additional relevant MeSH terms:
Rectal Prolapse
Urinary Incontinence
Enuresis
Prolapse
Pelvic Organ Prolapse
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases