A randomized controlled trial between polytetrafluoroethylene mesh ORIHIME® and polypropylene mesh Gynemesh® PS, for laparoscopic sacrocolpopexy in the performance up to18m after surgery

Takeyama M1, Watanabe M1, Kuwata T1, Kashihara H1, Kato C1

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

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Abstract 240
Practical Urogynaecology
Scientific Podium Short Oral Session 28
Friday 29th September 2023
09:52 - 10:00
Room 104AB
Female Pelvic Organ Prolapse Prospective Study Surgery
1. First Towakai hospital
Presenter
M

Masami Takeyama

Links

Abstract

Hypothesis / aims of study
Laparoscopic sacrocolpopexy (LSC) procedures are widely performed as the gold standard for pelvic organ prolapse repair and polypropylene (PP) mesh has been used in LSC procedures.  Since 2017, polytetrafluoroethylene (PTFE) mesh ORIHIME® has been available in Japan for pelvic organ prolapse surgery, and  has become used in LSC.  Characteristics of the PTFE mesh ORIHIME®and PP mesh Gynemesh® PS are shown in Table 1.  PTFE mesh is a potential material for the reconstruction of pelvic floor, however, there have not been any report on the LSC using PTFE mesh. We have reported mid-term performance of LSC using PTFE mesh ORIHIME® up to 3 years after surgery and the data showed PTFE mesh has potential in reconstructing the female pelvic floor of POP patient(1).  The aim of the study is to confirm the feasibility of LSC with ORIHIME® mesh by the comparative study about the efficacy and safety of LSC with this mesh using LSC with PP mesh Gynemesh® PS as a control.
Study design, materials and methods
Study design: a randomised controlled trial. Materials: 100 patients with planned LSC for pelvic organ prolapse (POP).  METHODS: Immediately before surgery, patients were randomly assigned to the PP group or the PTFE group. Operation: subtotal hysterectomy was performed in all cases by French style LSC using double mesh. The port location and mesh shapes are shown in Fig 1. The surgical procedure was performed according to that reported by Watiez et al.(2). 
 First, the anterior aspect of the promontorium is dissected to identify the anterior longitudinal ligament and to confirm that the mesh can be fixed to it. Next, the subtotal hysterectomy is performed, the uterus is placed in the retrieval bag, and then the stump of uterine cervix is suspended on the abdominal wall.  Next, the space between the rectum and posterior vaginal wall is dissected to expose the puborectal muscle on both sides, and the distal end of the posterior mesh was sewn to the both sides of the puborectal muscle with non-absorbable threads. Next, the space between the bladder and the anterior vaginal wall is dissected, and the distal end of the anterior mesh was sewn to the anterior vaginal wall with 5 stitches of non-absorbable threads.  Next, both anterior and posterior mesh and the cervical tissue were integrated with 3 stitches of non-absorbable threads. 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.  The mesh is then retroperitonealized using a continuous suture of absorbable thread. The uterus is cut into small pieces and removed through the camera port.
Compile perioperative complications, recurrence up to 18 months after surgery and complications including post-operative pain during sexual intercourse. POPQ stage 2 or higher was defined as recurrence.
Results
Results: Patient background in PP group and PTFE group: average age 65.2 and 68.2, parity 2.2 and 2.3, BMI 22.6 ±1.9, 22.7±1.9 respectively. As a history of POP surgery, 1 case of vaginal wall plasty in the PP group and 1 case of TVM in the PTFE group were observed.  Concomitant surgical procedures included cervical resection in 1 patient in the PP group and cervical myomectomy in 1 patient in the PTFE group. 45 patients in the PP group and 44 patients in the PTFE group were followed up to 18 months after surgery. Recurrence was observed in 1 patient (2.2%) in the PP group and 3 patients (6.8%) in the PTFE group. No mesh erosion was observed in either group. As for pain during sexual intercourse, 4 cases in the PP group and 2 cases in the PTFE group were observed postoperatively.
Interpretation of results
LSC with PTFE mesh has as good results as that with PP mesh. There was also no mesh complication, suggesting that PTFE mesh can be safely used in LSC.
Concluding message
Concluding message: LSC using PTFE mesh is feasible. As PTFE is less prone to cause inflammation with surrounding tissue, it may be useful for young , sexually active, and those who are concerned about mesh exposure such as after hysterectomy.
Figure 1 Table1 Characteristics of ORIHIME®and Gynemesh®PS
Figure 2 Fig. 1 Port location and Mesh shapes
References
  1. Takeyama M., Watanabe M. Kuwata T, Kashihara H, Kato C, Mid-term performance of laparoscopic sacrocolpopexy using polytetrafluoroethylene mesh ORIHIME®, Continence Reports 5(2023) 100022
  2. A. Wattiez, S. Boughizane, F. Alexandre, M. Canis, G.Mage, J.L. Pouly, M.A. Bruhat, Laparoscopic procedures for stress incontinence and prolapse. Curr Opin Obstet Gynecol. 1995 Aug;7(4):317-21.
Disclosures
Funding This research did not receive any specific grant from funding agency in the public, commercial, or non -for-profit sectors Clinical Trial Yes Public Registry No RCT Yes Subjects Human Ethics Committee Ethics committee of Towakai medical corporation Helsinki Yes Informed Consent Yes
Citation

Continence 7S1 (2023) 100958
DOI: 10.1016/j.cont.2023.100958

26/06/2024 22:41:59