AbsorbaTackTM vs. ProTackTM vs. suture material - a biomechanical analysis of cervical fixation methods for laparoscopic apical fixation (with PVDF tapes) in a porcine model

Ludwig S1, Jansen A1, Trageser N1, Thangerajah F1, Karapanos L2, Rudroff C3, Eichler C1, Mallmann P1

Research Type

Pure and Applied Science / Translational

Abstract Category

Anatomy / Biomechanics

Abstract 101
On Demand Anatomy / Biomechanics
Scientific Open Discussion Session 12
On-Demand
Biomechanics Animal Study Grafts: Synthetic Pelvic Organ Prolapse Pelvic Floor
1. Dept. Obstetrics and Gynecology, University of Cologne, Cologne Germany, 2. Dept. of Urology, University of Cologne, Cologne Germany, 3. Department of Visceral Surgery and Functional Surgery of the Lower Gastrointestinal Tract (UGI), Clinic for General and Visceral Surgery Evangelisches Klinikum Köln Weyertal, Germany
Presenter
Links

Abstract

Hypothesis / aims of study
The incidence of apical uterine descent increases with age. After conservative treatment options have been exhausted, surgical correction with the use of alloplastic material often follows. Laparoscopic cervicosacropexy is often performed, and different materials (staplers vs. sutures) can be used to fix the mesh material to the cervix for apical fixation.
The aim of this in vitro study was to compare the biomechanical properties for fixation of the mesh to the cervix with single button sutures (group 1), non-absorbable staplers (group 2) and absorbable staplers (group 3).
Study design, materials and methods
The biomechanical in vitro testing was performed on porcine, non- embalmed, fresh and unfrozen cadaver uteri. In a two-column material testing machine (Instron 5565®) a total of 28 trials were conducted in three groups on uncollected fresh porcine uteri. Each group evaluated the cervical mesh fixation with a different fixation device: Group 1 (n=10) evaluated three interrupted sutures, group 2 (n=10) three titanium tacks (ProTackTM), and group 3 (n=8) three absorbable tacks (AbsorbaTackTM). The mesh used for cervical fixation are composed of nonabsorbable, biostable polyvinylidene fluoride (PVDF) monofilaments.
All trials were conducted until failure of the mesh, tissue or fixation device occurred. Primary endpoints were biomechanical properties maximum load (N), displacement at failure (mm) and stiffness (N/mm). Mode of failure was evaluated as a secondary endpoint.
Results
Significant differences were found between all three groups in terms of maximum load: Group 1 (three single button staples) showed a maximum load of 64 ± 15 N, Group 2 (three titanium staples) 41 ± 10 N and Group 3 (three absorbable staples) reached a maximum load of 15 ± 8 N.
The most common mode of failure for group 1 and 2 was a net tear or rip. In group 3, the limiting factor in all tests was a pull-out of the absorbable tacker.
Interpretation of results
Fixation of the PVDF tape with three single button sutures is superior to fixation with three titanium staplers as well as absorbable staplers in terms of maximum load. The suture carries 1.5 times the load of titanium staplers and 4.2 times the load of absorbable staplers. All three fixation options can withstand the physiological load of 10 N. Single button sutures are the significantly stronger and less expensive, but could increase surgical time by a factor of 9 compared to staplers. Possible risks of the staplers are not considered in this in vitro analysis.
Concluding message
All three fixation options showed the required strength. Sutures are an inexpensive and stable fixation, but can sometimes lead to increased operating time. In none of the cases did the mesh material show weaknesses.
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Disclosures
Funding none Clinical Trial Yes Public Registry No RCT No Subjects Animal Species porcine fresh cadaver uteri Ethics Committee Ethical committee of the Ärztekammer Nordrhein, Düsseldorf, Germany
14/10/2024 21:41:56