An interventional study of Synthetic glue IfabondTM and Glue-Free Suture Technique in Prolapse, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment
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.
93 studies on the registry are indexed under Prolapse; 9 are open to participants now.
This study's enrollment of 54 is below the median of 70 across 65 interventional studies indexed under Prolapse.
Browse Prolapse studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use of the synthetic glue IfabondTM
Device: Synthetic glue IfabondTM
Glue-Free Suture Technique
Procedure: Glue-Free Suture Technique
Use of the synthetic glue IfabondTM
Suture Technique
duration of surgery
time of surgery in minutes (measured by chronometers)
Time frame: Day 0
Percentage prolapse correction failure
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
Time frame: at 1 months post-surgery
Percentage prolapse correction failure
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
Time frame: at 12 months post-surgery
Percentage prolapse correction failure
A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
Time frame: at 24 months post-surgery
complications
Time frame: at day 0
complications
Time frame: at 1 months post-surgery
complications
Time frame: at 12 months post-surgery
complications
Time frame: at 24 months post-surgery
pain
assessed by visual analog scale (VAS)
Time frame: at day 0
pain
assessed by visual analog scale (VAS)
Time frame: at 1 months post-surgery
pain
assessed by visual analog scale (VAS)
Time frame: at 12 months post-surgery
pain
assessed by visual analog scale (VAS)
Time frame: at 24 months post-surgery
quality of life
assessed by the questionnaires Short Form Health Survey-12 (SF-12)
Time frame: at 1 months post-surgery
quality of life
assessed by the questionnaires Pelvic Floor Distress Inventory -20 (PFDI-20)
Time frame: at 1 months post-surgery
quality of life
assessed by the questionnaires Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
Time frame: at 1 months post-surgery
quality of life
assessed by the questionnaires Patient Global Impression of Improvement (PGI-I)
Time frame: at 1 months post-surgery
quality of life
assessed by the questionnaires SF-12
Time frame: at 12 months post-surgery
quality of life
assessed by the questionnaires PFDI-20
Time frame: at 12 months post-surgery
quality of life
assessed by the questionnaires PFIQ-7
Time frame: at 12 months post-surgery
quality of life
assessed by the questionnaires PGI-I
Time frame: at 12 months post-surgery
quality of life
assessed by the questionnaires SF-12
Time frame: at 24 months post-surgery
quality of life
assessed by the questionnaires PFDI-20
Time frame: at 24 months post-surgery
quality of life
assessed by the questionnaires PFIQ-7
Time frame: at 24 months post-surgery
quality of life
assessed by the questionnaires PGI-I
Time frame: at 24 months post-surgery
sexuality score
assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12)
Time frame: at 1 months post-surgery
sexuality score
assessed by the questionnaire PISQ-12
Time frame: at 12 months post-surgery
sexuality score
assessed by the questionnaire PISQ-12
Time frame: at 24 months post-surgery
percentage of dyspareunia
Time frame: at 1 months post-surgery
percentage of dyspareunia
Time frame: at 12 months post-surgery
percentage of dyspareunia
Time frame: at 24 months post-surgery
percentage of urinary incontinence
Time frame: at 1 months post-surgery
percentage of urinary incontinence
Time frame: at 12 months post-surgery
percentage of urinary incontinence
Time frame: at 24 months post-surgery
Plan to share: Undecided
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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