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Operative Time During the Use of the Synthetic Glue IFABONDTM in Laparoscopic Sacrocolpopexy (Procolle 2)

Primary Purpose

Prolapse

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Synthetic glue IfabondTM
Glue-Free Suture Technique
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prolapse focused on measuring Laparoscopic Surgery, synthetic glue IFABONDTM, time of surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IfabondTM

sutures

Arm Description

Use of the synthetic glue IfabondTM

Glue-Free Suture Technique

Outcomes

Primary Outcome Measures

duration of surgery
time of surgery in minutes (measured by chronometers)

Secondary Outcome Measures

Percentage prolapse correction failure
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
Percentage prolapse correction failure
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
Percentage prolapse correction failure
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
complications
complications
complications
complications
pain
assessed by visual analog scale (VAS)
pain
assessed by visual analog scale (VAS)
pain
assessed by visual analog scale (VAS)
pain
assessed by visual analog scale (VAS)
quality of life
assessed by the questionnaires Short Form Health Survey-12 (SF-12)
quality of life
assessed by the questionnaires Pelvic Floor Distress Inventory -20 (PFDI-20)
quality of life
assessed by the questionnaires Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
quality of life
assessed by the questionnaires Patient Global Impression of Improvement (PGI-I)
quality of life
assessed by the questionnaires SF-12
quality of life
assessed by the questionnaires PFDI-20
quality of life
assessed by the questionnaires PFIQ-7
quality of life
assessed by the questionnaires PGI-I
quality of life
assessed by the questionnaires SF-12
quality of life
assessed by the questionnaires PFDI-20
quality of life
assessed by the questionnaires PFIQ-7
quality of life
assessed by the questionnaires PGI-I
sexuality score
assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12)
sexuality score
assessed by the questionnaire PISQ-12
sexuality score
assessed by the questionnaire PISQ-12
percentage of dyspareunia
percentage of dyspareunia
percentage of dyspareunia
percentage of urinary incontinence
percentage of urinary incontinence
percentage of urinary incontinence

Full Information

First Posted
October 3, 2017
Last Updated
January 13, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03307824
Brief Title
Operative Time During the Use of the Synthetic Glue IFABONDTM in Laparoscopic Sacrocolpopexy
Acronym
Procolle 2
Official Title
A Multicenter Randomized Study on Operative Time When Using IFABOND™ Synthetic Glue in Laparoscopic Sacrocolpopexy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
November 20, 2024 (Anticipated)
Study Completion Date
November 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Laparoscopic sacrocolpopexy has now become the gold standard technique for correction of anterior and apical prolapse. In order to provide an alternative to stapling system and sutures involving vaginal erosion and shrinkage phenomena, there is a technique to fix material meshes by the use of a liquid, tissue, synthetic adhesive and sterile. The investigator hypothesizes that the use of IFABOND ™ adhesive in laparoscopic sacrocolpopexy significantly reduces the time of surgery compared to the classic suture technique. The prospective, randomized, multicenter study therefore aims to compare the time of surgery when using the IFABOND™ synthetic adhesive and the technique by sutures to fix material meshes in laparoscopic sacrocolpopexy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse
Keywords
Laparoscopic Surgery, synthetic glue IFABONDTM, time of surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IfabondTM
Arm Type
Experimental
Arm Description
Use of the synthetic glue IfabondTM
Arm Title
sutures
Arm Type
Active Comparator
Arm Description
Glue-Free Suture Technique
Intervention Type
Device
Intervention Name(s)
Synthetic glue IfabondTM
Intervention Description
Use of the synthetic glue IfabondTM
Intervention Type
Procedure
Intervention Name(s)
Glue-Free Suture Technique
Intervention Description
Suture Technique
Primary Outcome Measure Information:
Title
duration of surgery
Description
time of surgery in minutes (measured by chronometers)
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Percentage prolapse correction failure
Description
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
Time Frame
at 1 months post-surgery
Title
Percentage prolapse correction failure
Description
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
Time Frame
at 12 months post-surgery
Title
Percentage prolapse correction failure
Description
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
Time Frame
at 24 months post-surgery
Title
complications
Time Frame
at day 0
Title
complications
Time Frame
at 1 months post-surgery
Title
complications
Time Frame
at 12 months post-surgery
Title
complications
Time Frame
at 24 months post-surgery
Title
pain
Description
assessed by visual analog scale (VAS)
Time Frame
at day 0
Title
pain
Description
assessed by visual analog scale (VAS)
Time Frame
at 1 months post-surgery
Title
pain
Description
assessed by visual analog scale (VAS)
Time Frame
at 12 months post-surgery
Title
pain
Description
assessed by visual analog scale (VAS)
Time Frame
at 24 months post-surgery
Title
quality of life
Description
assessed by the questionnaires Short Form Health Survey-12 (SF-12)
Time Frame
at 1 months post-surgery
Title
quality of life
Description
assessed by the questionnaires Pelvic Floor Distress Inventory -20 (PFDI-20)
Time Frame
at 1 months post-surgery
Title
quality of life
Description
assessed by the questionnaires Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
Time Frame
at 1 months post-surgery
Title
quality of life
Description
assessed by the questionnaires Patient Global Impression of Improvement (PGI-I)
Time Frame
at 1 months post-surgery
Title
quality of life
Description
assessed by the questionnaires SF-12
Time Frame
at 12 months post-surgery
Title
quality of life
Description
assessed by the questionnaires PFDI-20
Time Frame
at 12 months post-surgery
Title
quality of life
Description
assessed by the questionnaires PFIQ-7
Time Frame
at 12 months post-surgery
Title
quality of life
Description
assessed by the questionnaires PGI-I
Time Frame
at 12 months post-surgery
Title
quality of life
Description
assessed by the questionnaires SF-12
Time Frame
at 24 months post-surgery
Title
quality of life
Description
assessed by the questionnaires PFDI-20
Time Frame
at 24 months post-surgery
Title
quality of life
Description
assessed by the questionnaires PFIQ-7
Time Frame
at 24 months post-surgery
Title
quality of life
Description
assessed by the questionnaires PGI-I
Time Frame
at 24 months post-surgery
Title
sexuality score
Description
assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12)
Time Frame
at 1 months post-surgery
Title
sexuality score
Description
assessed by the questionnaire PISQ-12
Time Frame
at 12 months post-surgery
Title
sexuality score
Description
assessed by the questionnaire PISQ-12
Time Frame
at 24 months post-surgery
Title
percentage of dyspareunia
Time Frame
at 1 months post-surgery
Title
percentage of dyspareunia
Time Frame
at 12 months post-surgery
Title
percentage of dyspareunia
Time Frame
at 24 months post-surgery
Title
percentage of urinary incontinence
Time Frame
at 1 months post-surgery
Title
percentage of urinary incontinence
Time Frame
at 12 months post-surgery
Title
percentage of urinary incontinence
Time Frame
at 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
Géry LAMBLIN, MD
Organizational Affiliation
Gynaecology Department, Hôpital Femme Mère Enfant, HCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynaecology Department, Hôpital Femme Mère Enfant
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Operative Time During the Use of the Synthetic Glue IFABONDTM in Laparoscopic Sacrocolpopexy

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