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

Medial and/or Anterior Genital Prolapse Clinical Trial

— PRO-COLLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011373
• Other study ID #: 2013.804
• Status: Completed
• Phase: N/A
• Start date: November 6, 2013
• Est. completion date: October 30, 2018

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medial and/or Anterior Genital Prolapse
• Prolapse

Intervention

Procedure:
• fixation technique using a sterile synthetic liquid tissue glue: IFABOND™

Locations

Country	Name	City	State
France	Gynaecology Department, Hôpital Femme Mère Enfant	Bron
France	Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon	Lyon
France	Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon	Pierre-Bénite

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Vitalitec

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage prolapse correction failure		12 months post-surgery
Secondary	Percentage prolapse correction failure		24 months post-surgery
Secondary	Percentage immediate postoperative failure		1 month post-surgery
Secondary	Complications rate		Peroperative and 1, 12 and 24 months post-surgery
Secondary	Quality of life score		1, 12 and 24 months post-surgery