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

NCT ID: NCT03307824

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-20
• Study Completion Date: 2023-12-15

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.

Conditions

Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IfabondTM

Use of the synthetic glue IfabondTM

Group Type: EXPERIMENTAL

Synthetic glue IfabondTM

Intervention Type: DEVICE

Use of the synthetic glue IfabondTM

sutures

Glue-Free Suture Technique

Group Type: ACTIVE_COMPARATOR

Glue-Free Suture Technique

Intervention Type: PROCEDURE

Suture Technique

Interventions

Synthetic glue IfabondTM

Use of the synthetic glue IfabondTM

Intervention Type: DEVICE

Glue-Free Suture Technique

Suture Technique

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Géry LAMBLIN, MD

Role: PRINCIPAL_INVESTIGATOR

Gynaecology Department, Hôpital Femme Mère Enfant, HCL

Locations

Gynaecology Department, Hôpital Femme Mère Enfant

Bron, , France

Countries

France

Other Identifiers

2017-A01405-48

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL16_0647

Identifier Type: -

Identifier Source: org_study_id