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

NCT03307824 | Completed

• 2 other identifiers: 69HCL16_06472017-A01405-48
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Keywords

Laparoscopic Surgery; synthetic glue IFABONDTM; time of surgery

Outcome Measures

Primary Outcomes (1)

• duration of surgery

  time of surgery in minutes (measured by chronometers)

  Day 0

Secondary Outcomes (32)

• Percentage prolapse correction failure

  at 1 months post-surgery

• Percentage prolapse correction failure

  at 12 months post-surgery

• Percentage prolapse correction failure

  at 24 months post-surgery

• complications

  at day 0

• complications

  at 1 months post-surgery

Study Arms (2)

IfabondTM

EXPERIMENTAL

Use of the synthetic glue IfabondTM

Device: Synthetic glue IfabondTM

sutures

ACTIVE COMPARATOR

Glue-Free Suture Technique

Procedure: Glue-Free Suture Technique

Interventions

Synthetic glue IfabondTM DEVICE

Use of the synthetic glue IfabondTM

IfabondTM

Glue-Free Suture Technique PROCEDURE

Suture Technique

sutures

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Gynaecology Department, Hôpital Femme Mère Enfant

Bron, 69500, France

Location

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Géry LAMBLIN, MD

  Gynaecology Department, Hôpital Femme Mère Enfant, HCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 12, 2017
• Study Start: November 20, 2017
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

FR (1)