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NCT Number: NCT03307824

Operative Time During the Use of the Synthetic Glue IFABONDTM 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.

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Key information

Conditions

Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gynaecology Department, Hôpital Femme Mère Enfant

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synthetic glue IfabondTM

Device

Use of the synthetic glue IfabondTM

Glue-Free Suture Technique

Procedure

Suture Technique

Primary outcomes

  1. duration of surgery

    Time frame: Day 0

    time of surgery in minutes (measured by chronometers)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. complications

    Time frame: at day 0

  5. complications

    Time frame: at 1 months post-surgery

  6. complications

    Time frame: at 12 months post-surgery

  7. complications

    Time frame: at 24 months post-surgery

  8. pain

    Time frame: at day 0

    assessed by visual analog scale (VAS)

  9. pain

    Time frame: at 1 months post-surgery

    assessed by visual analog scale (VAS)

  10. pain

    Time frame: at 12 months post-surgery

    assessed by visual analog scale (VAS)

  11. pain

    Time frame: at 24 months post-surgery

    assessed by visual analog scale (VAS)

  12. quality of life

    Time frame: at 1 months post-surgery

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

  13. quality of life

    Time frame: at 1 months post-surgery

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

  14. quality of life

    Time frame: at 1 months post-surgery

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

  15. quality of life

    Time frame: at 1 months post-surgery

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

  16. quality of life

    Time frame: at 12 months post-surgery

    assessed by the questionnaires SF-12

  17. quality of life

    Time frame: at 12 months post-surgery

    assessed by the questionnaires PFDI-20

  18. quality of life

    Time frame: at 12 months post-surgery

    assessed by the questionnaires PFIQ-7

  19. quality of life

    Time frame: at 12 months post-surgery

    assessed by the questionnaires PGI-I

  20. quality of life

    Time frame: at 24 months post-surgery

    assessed by the questionnaires SF-12

  21. quality of life

    Time frame: at 24 months post-surgery

    assessed by the questionnaires PFDI-20

  22. quality of life

    Time frame: at 24 months post-surgery

    assessed by the questionnaires PFIQ-7

  23. quality of life

    Time frame: at 24 months post-surgery

    assessed by the questionnaires PGI-I

  24. sexuality score

    Time frame: at 1 months post-surgery

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

  25. sexuality score

    Time frame: at 12 months post-surgery

    assessed by the questionnaire PISQ-12

  26. sexuality score

    Time frame: at 24 months post-surgery

    assessed by the questionnaire PISQ-12

  27. percentage of dyspareunia

    Time frame: at 1 months post-surgery

  28. percentage of dyspareunia

    Time frame: at 12 months post-surgery

  29. percentage of dyspareunia

    Time frame: at 24 months post-surgery

  30. percentage of urinary incontinence

    Time frame: at 1 months post-surgery

  31. percentage of urinary incontinence

    Time frame: at 12 months post-surgery

  32. percentage of urinary incontinence

    Time frame: at 24 months post-surgery

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: Procolle 2

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 12, 2017
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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