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Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study (PRO-COLLE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02011373
First Posted: December 13, 2013
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vitalitec
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but incurs problems of tolerance of implanted material. As an alternative to stapling and suturing, which cause vaginal erosion, we present a fixation technique using a sterile synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will assess efficacy in terms of 12-month failure of prolapse correction.

Condition Intervention
Medial and/or Anterior Genital Prolapse Procedure: fixation technique using a sterile synthetic liquid tissue glue: IFABOND™

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Percentage prolapse correction failure [ Time Frame: 12 months post-surgery ]

Secondary Outcome Measures:
  • Percentage prolapse correction failure [ Time Frame: 24 months post-surgery ]
  • Percentage immediate postoperative failure [ Time Frame: 1 month post-surgery ]
  • Complications rate [ Time Frame: Peroperative and 1, 12 and 24 months post-surgery ]
  • Quality of life score [ Time Frame: 1, 12 and 24 months post-surgery ]

Estimated Enrollment: 70
Study Start Date: November 6, 2013
Estimated Study Completion Date: March 6, 2018
Estimated Primary Completion Date: March 6, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IFABOND Procedure: fixation technique using a sterile synthetic liquid tissue glue: IFABOND™

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman aged 18 years or more
  • Stage III or IV medial and/or anterior genital prolapse on the Pelvic Organ Prolapse Quantification (POP-Q) classification (hysterocele and/or cystocele), requiring surgical correction
  • Patient requesting surgery for the trouble caused by the prolapse

Exclusion Criteria:

  • Prolapse of POP-Q stage <III or without functional impact
  • Unacceptable postoperative risk disclosed on interview: coagulation disorder, immune disorder, evolutive disease, etc.
  • Impaired lower-limb range of motion preventing positioning for surgery
  • Pregnancy or intended pregnancy during study period
  • Evolutive or latent infection or signs of tissue necrosis on clinical examination
  • Non-controlled diabetes (glycated haemoglobin >8%)
  • Treatment impacting immune response (immunomodulators), ongoing or within previous month
  • History of pelvic region radiation therapy, at any time
  • History of pelvic cancer
  • Non-controlled evolutive spinal pathology
  • Known hypersensitivity to one of the implant components (polypropylene)
  • Cyanoacrylate hypersensitivity
  • Formaldehyde hypersensitivity
  • Inability to understand information provided
  • No national health insurance cover; prisoner, or ward of court
  Contacts and Locations
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): NCT02011373


Locations
France
Gynaecology Department, Hôpital Femme Mère Enfant
Bron, France, 69677
Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, France, 69004
Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
Vitalitec
Investigators
Principal Investigator: Gery Lamblin, MD Gynaecology Department, Hôpital Femme Mère Enfant, Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02011373     History of Changes
Other Study ID Numbers: 2013.804
First Submitted: December 3, 2013
First Posted: December 13, 2013
Last Update Posted: August 22, 2017
Last Verified: May 2017

Keywords provided by Hospices Civils de Lyon:
prolapse, laparoscopic sacrocolpopexy, IFABONDTM glue

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical