Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study

Not Applicable

Completed

• Conditions: Medial and/or Anterior Genital Prolapse

• Registration Number: NCT02011373
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-06
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-13
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage prolapse correction failure	12 months post-surgery

Secondary Outcome Measures

Name	Time	Method
Percentage immediate postoperative failure	1 month post-surgery
Percentage prolapse correction failure	24 months post-surgery
Quality of life score	1, 12 and 24 months post-surgery
Complications rate	Peroperative and 1, 12 and 24 months post-surgery

Trial Locations

Locations (3)

Gynaecology Department, Hôpital Femme Mère Enfant; 🇫🇷 Bron, France

Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France

Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon; 🇫🇷 Lyon, France