Hypothesis / aims of study
Background:
Polytetrafluoroethylene(PTFE) is a potential material for the reconstruction of pelvic floor as it is chemically stable with rare degradation and causes few tissue reactions. It has been used for a long time in various medical fields such as artificial blood vessels, therapeutic cardiac patches and meshes for abdominal wall hernias. Fig.1 shows the characteristics of the PTFE mesh “ORIHIME”. The pore size is almost the same as that of Gynemesh®PS and it weighs about twice as much as Gynemesh®PS. The result of the breaking strength test shows that the minimum breaking load of ORIHIME is larger than that of Gynemesh®PS and Polyform® and the material is tough enough to be used for pelvic floor repair. In addition ORIHIME can be visualized by computed tomographic images(1), and this characteristic makes it possible to identify the changes in the mesh shape after surgery as well as the cause of recurrence. When we use ORIHIME for the TVM procedure, we have to devise ways of coping with deviation of mesh arms. Since the friction coefficient is much smaller than that of polypropylene, deviation of mesh arms in the TVM procedure may hinder the reconstruction. In contrast, when the PTFE mesh is used in the procedure of laparoscopic sacrocolpopexy (LSC), the deviation of the mesh can be prevented by using non-absorbable strings for all the sutures. Furthermore, it is expected to cause few mesh-related complications such as mesh contraction and chronic pain in the long term because the material does not bring much tissue reaction or degradation.
Objectives:
The aim of the study is to confirm the feasibility of LSC with PTFE mesh “ORIHIME” by investigating the mid-term outcomes of LSC with “ORIHIME.”
Study design, materials and methods
Study design: Retrospective patient-record based single-arm study.
Materials and method: The materials were 31 patients with POP who underwent LSC using ORIHIME between August 16th and October 16th in 2018. The breakdown of the most descending parts was as follows: anterior wall 16, apical 12, anterior wall and apical 3. As for the POPQ stage, 8 were at stageⅣ, 22 at stageⅢ and 1 at stageⅡ.
Subtotal hysterectomy was performed in 30 patients by French style LSC using double mesh. The remaining 1 patient had already undergone hysterectomy. The shapes of the mesh are shown in Fig.2. The surgical procedure was performed according to that of Wattiez A et al (2). The distal end of the posterior mesh was sewn to the both sides of the puborectalis muscle with non-absorbable threads (Fig.2-A) and the distal end of the anterior mesh was sewn to the anterior vaginal wall with 5 stitches of non-absorbable threads (Fig.2-B). Both anterior and posterior mesh and the cervical tissue were integrated with 3 stitches of non-absorbable threads (Fig.2-C). The proximal end of the anterior mesh was sutured to the anterior longitudinal ligament at the level of L5 with a stitch of non-absorbable thread. The tension of the mesh was set to loosen slowly under a pneumoperitoneum pressure of 8 bar (Fig.2-D). The patients were followed up for three years after operation. We investigated the recurrence and complications. All values were described using the mean±standard deviation(SD) and analyzed with EZR, which is a graphical user interface for R. For continuous variables, Student’s t-test was used for analysis. The significance level was set at the p-value <0.05.
Results
Results: The age was 65.7±7.4 (47-77), BMI 22.7±2.1 (16.7-27.5), average number of vaginal deliveries 2.1(1-3), operation time 145±19.9 (106-185) min. and blood loss(ml) was 9.3±9.7 (5-50). We observed no perioperative complications.
We were able to follow up 31 cases for 3 months, 28 cases for 1 year, 24 cases for 2 years, and 19 cases for 3 years. As to complications, we observed 8 cases of de novo stress urinary incontinence but no mesh-related complications. Regarding the recurrence of POP, we saw 1 case of cystocele at 3-month check-up, 1 case of cervical extension at 2-year check-up, and 1 case of distal rectocele at 3-year check-up according to our recurrence criteria of the POPQ stage>Ⅱ.
Interpretation of results
The mid-term performance of LSC using ORIHIME is almost the same as that of LSC using Polypropylene mesh. We saw no serious complication. Recurrence rate is very small. De novo SUI is observed in more than 20% of the cases.