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

NCT ID: NCT02011373

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-06

Study Completion Date

2018-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Medial and/or Anterior Genital Prolapse

Keywords

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prolapse, laparoscopic sacrocolpopexy, IFABONDTM glue

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IFABOND

Group Type EXPERIMENTAL

fixation technique using a sterile synthetic liquid tissue glue: IFABOND™

Intervention Type PROCEDURE

Interventions

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fixation technique using a sterile synthetic liquid tissue glue: IFABOND™

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vitalitec

UNKNOWN

Sponsor Role collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gery Lamblin, MD

Role: PRINCIPAL_INVESTIGATOR

Gynaecology Department, Hôpital Femme Mère Enfant, Lyon

Locations

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Gynaecology Department, Hôpital Femme Mère Enfant

Bron, , France

Site Status

Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

Lyon, , France

Site Status

Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, , France

Site Status

Countries

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France

References

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Lamblin G, Chene G, Warembourg S, Jacquot F, Moret S, Golfier F. Glue mesh fixation in laparoscopic sacrocolpopexy: results at 3 years' follow-up. Int Urogynecol J. 2022 Sep;33(9):2533-2541. doi: 10.1007/s00192-021-04764-4. Epub 2021 Mar 20.

Reference Type RESULT
PMID: 33742249 (View on PubMed)

Other Identifiers

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2013.804

Identifier Type: -

Identifier Source: org_study_id