Clinical Trial: Materiovigilance After Urinary Incontinence or Prolapse Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women.

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.

Detailed Summary:

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.

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.

Estimate the number of annual procedures with mesh for the surgery of urinary incontinence, genital prolapse, and rectal prolapse in France.

Estimate the exhaustivity of the current implantable medical device surveillance compared to our reinforced observatory.

Estimate the accuracy of the surgical procedure coding compared to the title of the surgical procedures.

Estimate the cost of surgical treatment of urinary incontinence, genital prolapse and rectal prolapse in France.

MAIN OUTCOME Per- and post-operative complications (less than 12 months after surgery), or late (after 12 months) grade III or higher according to the Clavien-Dindo classification

OTHER OUTCOMES Estimation of the number of hospitalisations in France will use the data of the ATIH (Agence Technique de l'Information sur l'H
Sponsor: Poitiers University Hospital

Current Primary Outcome: Incidence of severe complications [ Time Frame: 10 years ]

Grade III or more according to Clavien-Dindo classification


Original Primary Outcome: Estimate the incidence of severe complications during or after surgery of urinary incontinence or pelvic organ prolapse in adult women [ Time Frame: 2 years ]

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Estimate the incidence of severe complications after urinary incontinence or prolapse surgery as a function of time since surgery. [ Time Frame: 2 years ]
  • 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. [ Time Frame: 2 years ]
  • Estimate the number of annual procedures with mesh for the surgery of urinary incontinence, genital prolapse, and rectal prolapse in France. [ Time Frame: 2 years ]
  • Estimate the exhaustivity of the current implantable medical device surveillance compared to our reinforced observatory. [ Time Frame: 2 years ]
  • Estimate the accuracy of the surgical procedure coding compared to the title of the surgical procedures. [ Time Frame: 2 years ]
  • Estimate the cost of surgical treatment of urinary incontinence, genital prolapse and rectal prolapse in France. [ Time Frame: 2 years ]


Information By: Poitiers University Hospital

Dates:
Date Received: February 10, 2017
Date Started: February 14, 2017
Date Completion: June 2019
Last Updated: February 14, 2017
Last Verified: February 2017