Operative Time During the Use of the Synthetic Glue IFABONDTM in Laparoscopic Sacrocolpopexy (Procolle 2)

A Multicenter Randomized Study on Operative Time When Using IFABOND™ Synthetic Glue in Laparoscopic Sacrocolpopexy

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.

Study Overview

• Status: Completed
• Conditions: Prolapse
• Intervention / Treatment: Device: Synthetic glue IfabondTM; Procedure: Glue-Free Suture Technique

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Gynaecology Department, Hôpital Femme Mère Enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IfabondTM; Use of the synthetic glue IfabondTM	Device: Synthetic glue IfabondTM; Use of the synthetic glue IfabondTM
Active Comparator: sutures; Glue-Free Suture Technique	Procedure: Glue-Free Suture Technique; Suture Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of surgery	time of surgery in minutes (measured by chronometers)	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage prolapse correction failure	A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification	at 1 months post-surgery
Percentage prolapse correction failure	A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification	at 12 months post-surgery
Percentage prolapse correction failure	A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification	at 24 months post-surgery
complications		at day 0
complications		at 1 months post-surgery
complications		at 12 months post-surgery
complications		at 24 months post-surgery
pain	assessed by visual analog scale (VAS)	at day 0
pain	assessed by visual analog scale (VAS)	at 1 months post-surgery
pain	assessed by visual analog scale (VAS)	at 12 months post-surgery
pain	assessed by visual analog scale (VAS)	at 24 months post-surgery
quality of life	assessed by the questionnaires Short Form Health Survey-12 (SF-12)	at 1 months post-surgery
quality of life	assessed by the questionnaires Pelvic Floor Distress Inventory -20 (PFDI-20)	at 1 months post-surgery
quality of life	assessed by the questionnaires Pelvic Floor Impact Questionnaire-7 (PFIQ-7)	at 1 months post-surgery
quality of life	assessed by the questionnaires Patient Global Impression of Improvement (PGI-I)	at 1 months post-surgery
quality of life	assessed by the questionnaires SF-12	at 12 months post-surgery
quality of life	assessed by the questionnaires PFDI-20	at 12 months post-surgery
quality of life	assessed by the questionnaires PFIQ-7	at 12 months post-surgery
quality of life	assessed by the questionnaires PGI-I	at 12 months post-surgery
quality of life	assessed by the questionnaires SF-12	at 24 months post-surgery
quality of life	assessed by the questionnaires PFDI-20	at 24 months post-surgery
quality of life	assessed by the questionnaires PFIQ-7	at 24 months post-surgery
quality of life	assessed by the questionnaires PGI-I	at 24 months post-surgery
sexuality score	assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12)	at 1 months post-surgery
sexuality score	assessed by the questionnaire PISQ-12	at 12 months post-surgery
sexuality score	assessed by the questionnaire PISQ-12	at 24 months post-surgery
percentage of dyspareunia		at 1 months post-surgery
percentage of dyspareunia		at 12 months post-surgery
percentage of dyspareunia		at 24 months post-surgery
percentage of urinary incontinence		at 1 months post-surgery
percentage of urinary incontinence		at 12 months post-surgery
percentage of urinary incontinence		at 24 months post-surgery

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Géry LAMBLIN, MD, Gynaecology Department, Hôpital Femme Mère Enfant, HCL

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (Actual): October 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Laparoscopic Surgery; synthetic glue IFABONDTM; time of surgery
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: 69HCL16_0647; 2017-A01405-48 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No