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Clinical Trials/NCT02011373
NCT02011373CompletedNot Applicable

Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study

Hospices Civils de Lyon6 sites in 1 country70 target enrollmentStarted: November 6, 2013Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
6
Primary Endpoint
Percentage prolapse correction failure
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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 \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

Arms & Interventions

IFABOND

Experimental

Intervention: fixation technique using a sterile synthetic liquid tissue glue: IFABOND™ (Procedure)

Outcomes

Primary Outcomes

Percentage prolapse correction failure

Time Frame: 12 months post-surgery

Secondary Outcomes

  • Complications rate(Peroperative and 1, 12 and 24 months post-surgery)
  • Percentage immediate postoperative failure(1 month post-surgery)
  • Percentage prolapse correction failure(24 months post-surgery)
  • Quality of life score(1, 12 and 24 months post-surgery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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