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

Prolapse Clinical Trial

— Procolle 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307824
• Other study ID #: 69HCL16_0647
• Secondary ID: 2017-A01405-48
• Status: Completed
• Phase: N/A
• Start date: November 20, 2017
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• 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

• Prolapse

Intervention

Device:
• Synthetic glue IfabondTM
Use of the synthetic glue IfabondTM

Procedure:
• Glue-Free Suture Technique
Suture Technique

Locations

Country	Name	City	State
France	Gynaecology Department, Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of surgery	time of surgery in minutes (measured by chronometers)	Day 0
Secondary	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
Secondary	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
Secondary	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
Secondary	complications		at day 0
Secondary	complications		at 1 months post-surgery
Secondary	complications		at 12 months post-surgery
Secondary	complications		at 24 months post-surgery
Secondary	pain	assessed by visual analog scale (VAS)	at day 0
Secondary	pain	assessed by visual analog scale (VAS)	at 1 months post-surgery
Secondary	pain	assessed by visual analog scale (VAS)	at 12 months post-surgery
Secondary	pain	assessed by visual analog scale (VAS)	at 24 months post-surgery
Secondary	quality of life	assessed by the questionnaires Short Form Health Survey-12 (SF-12)	at 1 months post-surgery
Secondary	quality of life	assessed by the questionnaires Pelvic Floor Distress Inventory -20 (PFDI-20)	at 1 months post-surgery
Secondary	quality of life	assessed by the questionnaires Pelvic Floor Impact Questionnaire-7 (PFIQ-7)	at 1 months post-surgery
Secondary	quality of life	assessed by the questionnaires Patient Global Impression of Improvement (PGI-I)	at 1 months post-surgery
Secondary	quality of life	assessed by the questionnaires SF-12	at 12 months post-surgery
Secondary	quality of life	assessed by the questionnaires PFDI-20	at 12 months post-surgery
Secondary	quality of life	assessed by the questionnaires PFIQ-7	at 12 months post-surgery
Secondary	quality of life	assessed by the questionnaires PGI-I	at 12 months post-surgery
Secondary	quality of life	assessed by the questionnaires SF-12	at 24 months post-surgery
Secondary	quality of life	assessed by the questionnaires PFDI-20	at 24 months post-surgery
Secondary	quality of life	assessed by the questionnaires PFIQ-7	at 24 months post-surgery
Secondary	quality of life	assessed by the questionnaires PGI-I	at 24 months post-surgery
Secondary	sexuality score	assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12)	at 1 months post-surgery
Secondary	sexuality score	assessed by the questionnaire PISQ-12	at 12 months post-surgery
Secondary	sexuality score	assessed by the questionnaire PISQ-12	at 24 months post-surgery
Secondary	percentage of dyspareunia		at 1 months post-surgery
Secondary	percentage of dyspareunia		at 12 months post-surgery
Secondary	percentage of dyspareunia		at 24 months post-surgery
Secondary	percentage of urinary incontinence		at 1 months post-surgery
Secondary	percentage of urinary incontinence		at 12 months post-surgery
Secondary	percentage of urinary incontinence		at 24 months post-surgery