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

December 13, 2025 updated by: Hospices Civils de Lyon
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Gynaecology Department, Hôpital Femme Mère Enfant
      • Lyon, France, 69004
        • Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
      • Pierre-Bénite, France, 69495
        • Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IFABOND
Procedure: fixation technique using a sterile synthetic liquid tissue glue: IFABOND™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage prolapse correction failure
Time Frame: 12 months post-surgery
12 months post-surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Collaborators

Vitalitec

Investigators

  • Principal Investigator: Gery Lamblin, MD, Gynaecology Department, Hôpital Femme Mère Enfant, Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2013

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

October 30, 2018

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimated)

December 13, 2013

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013.804

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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