Back to resultsEfficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study (PRO-COLLE)
Primary Purpose
Medial and/or Anterior Genital Prolapse
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fixation technique using a sterile synthetic liquid tissue glue: IFABOND™
Sponsored by
About this trial
This is an interventional treatment trial for Medial and/or Anterior Genital Prolapse focused on measuring prolapse, laparoscopic sacrocolpopexy, IFABONDTM glue
Eligibility 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
Sites / Locations
- Gynaecology Department, Hôpital Femme Mère Enfant
- Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
- Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IFABOND
Arm Description
Outcomes
Primary Outcome Measures
Percentage prolapse correction failure
Secondary Outcome Measures
Percentage prolapse correction failure
Percentage immediate postoperative failure
Complications rate
Quality of life score
Full Information
NCT ID
NCT02011373
First Posted
December 3, 2013
Last Updated
March 25, 2019
Sponsor
Hospices Civils de Lyon
Collaborators
Vitalitec
1. Study Identification
Unique Protocol Identification Number
NCT02011373
Brief Title
Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study
Acronym
PRO-COLLE
Official Title
Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 6, 2013 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
Collaborators
Vitalitec
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial and/or Anterior Genital Prolapse
Keywords
prolapse, laparoscopic sacrocolpopexy, IFABONDTM glue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IFABOND
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
fixation technique using a sterile synthetic liquid tissue glue: IFABOND™
Primary Outcome Measure Information:
Title
Percentage prolapse correction failure
Time Frame
12 months post-surgery
Secondary Outcome Measure Information:
Title
Percentage prolapse correction failure
Time Frame
24 months post-surgery
Title
Percentage immediate postoperative failure
Time Frame
1 month post-surgery
Title
Complications rate
Time Frame
Peroperative and 1, 12 and 24 months post-surgery
Title
Quality of life score
Time Frame
1, 12 and 24 months post-surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gery Lamblin, MD
Organizational Affiliation
Gynaecology Department, Hôpital Femme Mère Enfant, Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynaecology Department, Hôpital Femme Mère Enfant
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33742249
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study
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