Status:
COMPLETED
Operative Time During the Use of the Synthetic Glue IFABONDTM in Laparoscopic Sacrocolpopexy
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
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 vagin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03307824
Start Date
November 20 2017
End Date
December 15 2023
Last Update
February 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Gynaecology Department, Hôpital Femme Mère Enfant
Bron, France, 69500