Operative Time During the Use of the Synthetic Glue IFABONDTM in Laparoscopic Sacrocolpopexy

Not Applicable

Completed

• Conditions: Prolapse
• Interventions: Procedure: Glue-Free Suture Technique; Device: Synthetic glue IfabondTM

• Registration Number: NCT03307824
• Lead Sponsor: Hospices Civils de Lyon

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-12
• Study Start: 2017-11-20
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sutures	Glue-Free Suture Technique	Glue-Free Suture Technique
IfabondTM	Synthetic glue IfabondTM	Use of the synthetic glue IfabondTM

Primary Outcome Measures

Name	Time	Method
duration of surgery	Day 0	time of surgery in minutes (measured by chronometers)

Secondary Outcome Measures

Name	Time	Method
Percentage prolapse correction failure	at 24 months post-surgery	A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
complications	at 24 months post-surgery
pain	at 24 months post-surgery	assessed by visual analog scale (VAS)
percentage of dyspareunia	at 24 months post-surgery
sexuality score	at 24 months post-surgery	assessed by the questionnaire PISQ-12
quality of life	at 24 months post-surgery	assessed by the questionnaires PGI-I
percentage of urinary incontinence	at 24 months post-surgery

Trial Locations

Locations (1)

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