Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study (PRO-COLLE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but incurs problems of tolerance of implanted material. As an alternative to stapling and suturing, which cause vaginal erosion, we present a fixation technique using a sterile synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will assess efficacy in terms of 12-month failure of prolapse correction.
Condition or disease
Medial and/or Anterior Genital Prolapse
Procedure: fixation technique using a sterile synthetic liquid tissue glue: IFABOND™
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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