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ProlapseProcolle 2NCT03307824

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

A study testing Synthetic glue IfabondTM and Glue-Free Suture Technique in people with Prolapse, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Prolapse
What is being tested?
Synthetic glue IfabondTM and Glue-Free Suture Technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteFrance
Study dates
20 Nov 2017to 15 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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%)
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gynaecology Department, Hôpital Femme Mère Enfant

    Bron, 69500

Other trials in France

About this study

Official title: 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.

Conditions
Prolapse
Being tested
Synthetic glue IfabondTM, Glue-Free Suture Technique
Keywords
Laparoscopic Surgery, synthetic glue IFABONDTM, time of surgery
Medical subject headings
Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Synthetic glue IfabondTMDevice

    Use of the synthetic glue IfabondTM

  • Glue-Free Suture TechniqueProcedure or surgery

    Suture Technique

Study groups in NCT03307824
Study groupRoleWhat they receive
IfabondTMExperimentalUse of the synthetic glue IfabondTM
Receives: Device: Synthetic glue IfabondTM
suturesActive comparatorGlue-Free Suture Technique
Receives: Procedure: Glue-Free Suture Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. duration of surgery

    time of surgery in minutes (measured by chronometers)

    Measured: Day 0

Secondary outcomes (32)

  1. Percentage prolapse correction failure

    A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification

    Measured: at 1 months post-surgery

  2. Percentage prolapse correction failure

    A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification

    Measured: at 12 months post-surgery

  3. Percentage prolapse correction failure

    A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification

    Measured: at 24 months post-surgery

  4. complications

    Measured: at day 0

  5. complications

    Measured: at 1 months post-surgery

  6. complications

    Measured: at 12 months post-surgery

  7. complications

    Measured: at 24 months post-surgery

  8. pain

    assessed by visual analog scale (VAS)

    Measured: at day 0

  9. pain

    assessed by visual analog scale (VAS)

    Measured: at 1 months post-surgery

  10. pain

    assessed by visual analog scale (VAS)

    Measured: at 12 months post-surgery

  11. pain

    assessed by visual analog scale (VAS)

    Measured: at 24 months post-surgery

  12. quality of life

    assessed by the questionnaires Short Form Health Survey-12 (SF-12)

    Measured: at 1 months post-surgery

  13. quality of life

    assessed by the questionnaires Pelvic Floor Distress Inventory -20 (PFDI-20)

    Measured: at 1 months post-surgery

  14. quality of life

    assessed by the questionnaires Pelvic Floor Impact Questionnaire-7 (PFIQ-7)

    Measured: at 1 months post-surgery

  15. quality of life

    assessed by the questionnaires Patient Global Impression of Improvement (PGI-I)

    Measured: at 1 months post-surgery

  16. quality of life

    assessed by the questionnaires SF-12

    Measured: at 12 months post-surgery

  17. quality of life

    assessed by the questionnaires PFDI-20

    Measured: at 12 months post-surgery

  18. quality of life

    assessed by the questionnaires PFIQ-7

    Measured: at 12 months post-surgery

  19. quality of life

    assessed by the questionnaires PGI-I

    Measured: at 12 months post-surgery

  20. quality of life

    assessed by the questionnaires SF-12

    Measured: at 24 months post-surgery

  21. quality of life

    assessed by the questionnaires PFDI-20

    Measured: at 24 months post-surgery

  22. quality of life

    assessed by the questionnaires PFIQ-7

    Measured: at 24 months post-surgery

  23. quality of life

    assessed by the questionnaires PGI-I

    Measured: at 24 months post-surgery

  24. sexuality score

    assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12)

    Measured: at 1 months post-surgery

  25. sexuality score

    assessed by the questionnaire PISQ-12

    Measured: at 12 months post-surgery

  26. sexuality score

    assessed by the questionnaire PISQ-12

    Measured: at 24 months post-surgery

  27. percentage of dyspareunia

    Measured: at 1 months post-surgery

  28. percentage of dyspareunia

    Measured: at 12 months post-surgery

  29. percentage of dyspareunia

    Measured: at 24 months post-surgery

  30. percentage of urinary incontinence

    Measured: at 1 months post-surgery

  31. percentage of urinary incontinence

    Measured: at 12 months post-surgery

  32. percentage of urinary incontinence

    Measured: at 24 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2017
  2. Study start20 Nov 2017
  3. Primary completion15 Dec 2023
  4. Study completion15 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03307824
Sponsor's protocol ID
69HCL16_0647
Other IDs
2017-A01405-48
Acronym
Procolle 2
Status last verified
Feb 2024
First submitted
3 Oct 2017
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Synthetic glue IfabondTM and Glue-Free Suture Technique in people with Prolapse, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

duration of surgery (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03307824.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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