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

Hospices Civils de Lyon54 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prolapse

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

duration of surgery

time of surgery in minutes (measured by chronometers)

Time frame: Day 0

Secondary Outcomes

Percentage prolapse correction failure

A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification

Time frame: 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

Time frame: 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

Time frame: at 24 months post-surgery

complications

Time frame: at day 0

complications

Time frame: at 1 months post-surgery

complications

Time frame: at 12 months post-surgery

complications

Time frame: at 24 months post-surgery

pain

assessed by visual analog scale (VAS)

Time frame: at day 0

pain

assessed by visual analog scale (VAS)

Time frame: at 1 months post-surgery

pain

assessed by visual analog scale (VAS)

Time frame: at 12 months post-surgery

pain

assessed by visual analog scale (VAS)

Time frame: at 24 months post-surgery

quality of life

assessed by the questionnaires Short Form Health Survey-12 (SF-12)

Time frame: at 1 months post-surgery

quality of life

assessed by the questionnaires Pelvic Floor Distress Inventory -20 (PFDI-20)

Time frame: at 1 months post-surgery

quality of life

assessed by the questionnaires Pelvic Floor Impact Questionnaire-7 (PFIQ-7)

Time frame: at 1 months post-surgery

quality of life

assessed by the questionnaires Patient Global Impression of Improvement (PGI-I)

Time frame: at 1 months post-surgery

quality of life

assessed by the questionnaires SF-12

Time frame: at 12 months post-surgery

quality of life

assessed by the questionnaires PFDI-20

Time frame: at 12 months post-surgery

quality of life

assessed by the questionnaires PFIQ-7

Time frame: at 12 months post-surgery

quality of life

assessed by the questionnaires PGI-I

Time frame: at 12 months post-surgery

quality of life

assessed by the questionnaires SF-12

Time frame: at 24 months post-surgery

quality of life

assessed by the questionnaires PFDI-20

Time frame: at 24 months post-surgery

quality of life

assessed by the questionnaires PFIQ-7

Time frame: at 24 months post-surgery

quality of life

assessed by the questionnaires PGI-I

Time frame: at 24 months post-surgery

sexuality score

assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12)

Time frame: at 1 months post-surgery

sexuality score

assessed by the questionnaire PISQ-12

Time frame: at 12 months post-surgery

sexuality score

assessed by the questionnaire PISQ-12

Time frame: at 24 months post-surgery

percentage of dyspareunia

Time frame: at 1 months post-surgery

percentage of dyspareunia

Time frame: at 12 months post-surgery

percentage of dyspareunia

Time frame: at 24 months post-surgery

percentage of urinary incontinence

Time frame: at 1 months post-surgery

percentage of urinary incontinence

Time frame: at 12 months post-surgery

percentage of urinary incontinence

Time frame: at 24 months post-surgery

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes