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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Hospices Civils de Lyon
Sponsor:
Collaborator:
Vitalitec
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT02011373
First received: December 3, 2013
Last updated: December 10, 2013
Last verified: December 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Percentage prolapse correction failure [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage prolapse correction failure [ Time Frame: 24 months post-surgery ] [ Designated as safety issue: No ]
  • Percentage immediate postoperative failure [ Time Frame: 1 month post-surgery ] [ Designated as safety issue: No ]
  • Complications rate [ Time Frame: Peroperative and 1, 12 and 24 months post-surgery ] [ Designated as safety issue: Yes ]
  • Quality of life score [ Time Frame: 1, 12 and 24 months post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011373

Contacts
Contact: Stéphanie Ms Moret 4 72 35 58 78 ext +33 stephanie.moret@chu-lyon.fr

Locations
France
Gynaecology Department, Hôpital Femme Mère Enfant Recruiting
Bron, France, 69677
Contact: Stéphanie Moret    4 72 35 58 78 ext +33    stephanie.moret@chu-lyon.fr   
Principal Investigator: Gery Lamblin, MD         
Sub-Investigator: Philippe Chabert, MD         
Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon Recruiting
Lyon, France, 69004
Contact: Gil Dubernard, MD    472072866 ext +33    gil.dubernard@chu-lyon.fr   
Sub-Investigator: Pierre Jousselin de Saint Hilaire, MD         
Principal Investigator: Gil Dubernard, MD         
Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon Recruiting
Pierre-Bénite, France, 69495
Contact: François Golfier, MD    478864179 ext +33    francois.golfier@chu-lyon.fr   
Sub-Investigator: Daniel Raudrant, MD         
Principal Investigator: François Golfier, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Vitalitec
Investigators
Principal Investigator: Gery Lamblin, MD Gynaecology Department, Hôpital Femme Mère Enfant, Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02011373     History of Changes
Other Study ID Numbers: 2013.804
Study First Received: December 3, 2013
Last Updated: December 10, 2013
Health Authority: France: Committee for the Protection of Personnes
France: The Commission nationale de l’informatique et des libertés

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

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014