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

February 19, 2024 updated by: Hospices Civils de Lyon

A Multicenter Randomized Study on Operative Time When Using IFABOND™ Synthetic Glue in Laparoscopic Sacrocolpopexy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, 69500
        • Gynaecology Department, Hôpital Femme Mère Enfant

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IfabondTM
Use of the synthetic glue IfabondTM
Device: Synthetic glue IfabondTM
Use of the synthetic glue IfabondTM
Active Comparator: sutures
Glue-Free Suture Technique
Procedure: Glue-Free Suture Technique
Suture Technique

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
duration of surgery
Time Frame: Day 0
time of surgery in minutes (measured by chronometers)
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage prolapse correction failure
Time Frame: at 1 months post-surgery
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
at 1 months post-surgery
Percentage prolapse correction failure
Time Frame: at 12 months post-surgery
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
at 12 months post-surgery
Percentage prolapse correction failure
Time Frame: at 24 months post-surgery
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
at 24 months post-surgery
complications
Time Frame: at day 0
at day 0
complications
Time Frame: at 1 months post-surgery
at 1 months post-surgery
complications
Time Frame: at 12 months post-surgery
at 12 months post-surgery
complications
Time Frame: at 24 months post-surgery
at 24 months post-surgery
pain
Time Frame: at day 0
assessed by visual analog scale (VAS)
at day 0
pain
Time Frame: at 1 months post-surgery
assessed by visual analog scale (VAS)
at 1 months post-surgery
pain
Time Frame: at 12 months post-surgery
assessed by visual analog scale (VAS)
at 12 months post-surgery
pain
Time Frame: at 24 months post-surgery
assessed by visual analog scale (VAS)
at 24 months post-surgery
quality of life
Time Frame: at 1 months post-surgery
assessed by the questionnaires Short Form Health Survey-12 (SF-12)
at 1 months post-surgery
quality of life
Time Frame: at 1 months post-surgery
assessed by the questionnaires Pelvic Floor Distress Inventory -20 (PFDI-20)
at 1 months post-surgery
quality of life
Time Frame: at 1 months post-surgery
assessed by the questionnaires Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
at 1 months post-surgery
quality of life
Time Frame: at 1 months post-surgery
assessed by the questionnaires Patient Global Impression of Improvement (PGI-I)
at 1 months post-surgery
quality of life
Time Frame: at 12 months post-surgery
assessed by the questionnaires SF-12
at 12 months post-surgery
quality of life
Time Frame: at 12 months post-surgery
assessed by the questionnaires PFDI-20
at 12 months post-surgery
quality of life
Time Frame: at 12 months post-surgery
assessed by the questionnaires PFIQ-7
at 12 months post-surgery
quality of life
Time Frame: at 12 months post-surgery
assessed by the questionnaires PGI-I
at 12 months post-surgery
quality of life
Time Frame: at 24 months post-surgery
assessed by the questionnaires SF-12
at 24 months post-surgery
quality of life
Time Frame: at 24 months post-surgery
assessed by the questionnaires PFDI-20
at 24 months post-surgery
quality of life
Time Frame: at 24 months post-surgery
assessed by the questionnaires PFIQ-7
at 24 months post-surgery
quality of life
Time Frame: at 24 months post-surgery
assessed by the questionnaires PGI-I
at 24 months post-surgery
sexuality score
Time Frame: at 1 months post-surgery
assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12)
at 1 months post-surgery
sexuality score
Time Frame: at 12 months post-surgery
assessed by the questionnaire PISQ-12
at 12 months post-surgery
sexuality score
Time Frame: at 24 months post-surgery
assessed by the questionnaire PISQ-12
at 24 months post-surgery
percentage of dyspareunia
Time Frame: at 1 months post-surgery
at 1 months post-surgery
percentage of dyspareunia
Time Frame: at 12 months post-surgery
at 12 months post-surgery
percentage of dyspareunia
Time Frame: at 24 months post-surgery
at 24 months post-surgery
percentage of urinary incontinence
Time Frame: at 1 months post-surgery
at 1 months post-surgery
percentage of urinary incontinence
Time Frame: at 12 months post-surgery
at 12 months post-surgery
percentage of urinary incontinence
Time Frame: at 24 months post-surgery
at 24 months post-surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Géry LAMBLIN, MD, Gynaecology Department, Hôpital Femme Mère Enfant, HCL

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL16_0647
  • 2017-A01405-48 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Conditions

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