Characterization in respect to degradation of titanium-coated polypropylene surgical mesh explanted from humans.

Titanium-coated polypropylene (Ti-PP) mesh was introduced in 2002 as a surgical mesh for the treatment of hernias and shortly after for pelvic floor surgery, with the aim of improving biocompatibility when compared to non-titanised/regular PP mesh implants. The application of a titanium coating could also be beneficial to address concerns regarding the exposure of PP in an in vivo environment. Many studies have shown that PP, although it is widely accepted as a stable polymer, is subject to oxidation and degradation, such degradation affects the mechanical behavior, that is, the stiffness and tensile strength of PP mesh. Despite the wide clinical use of Ti-PP surgical meshes, no study has yet investigated the residual material properties post clinical deployment and subsequent explantation. In this study, two explanted Ti-PP mesh samples each having different incorporation durations from two patients were examined. Material analysis conducted within this study includes the following techniques: attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR), Raman spectroscopy, low voltage - scanning electron microscopy (LV-SEM), backscattered electron (BSE) imaging, energy dispersive X-ray spectroscopy (EDS) and secondary election hyperspectral imaging (SEHI). The hypothesis of this study is that the Ti coating successfully shields the PP mesh from oxidative stress in vivo and thus protects it from degradation. The results of this analysis show for the first time evidence of bulk oxidation, surface degradation, and environmental stress cracking on explanted Ti-PP meshes.

Laparoscopic versus vaginal native tissue repair in combination with pectopexy. Sub-analysis from an international, prospective, and multi-centre study: short term results.

INTRODUCTION: The use of mesh for vaginal repairs is currently problematic and as a consequence, there is increased interest in native tissue repair. We describe the follow-up data of a sub-analysis of a prospective and multi-center study focusing on the combination of pectopexy and native tissue repair. Patients were followed up for 12-18 months after surgery (+ SD: 15). Two-hundred and sixty-four patients attended the clinics for physical examination and were integrated into the follow-up. Cystocele repair was performed laparoscopically in 84 patients and vaginally in 52 patients. Posterior repair was performed vaginally in 40 patients and laparoscopically in 53 patients. RESULTS: Clinical success rate, patient recommendations and patient satisfaction rates were similar in both groups. The laparoscopic anterior repair resulted in an 89% cure or anatomical improvement rate; this compared to 94.2% for the vaginal approach. In the posterior group, laparoscopy resulted in a 94.3% cure or improvement rate compared to 97.5% in the second group. CONCLUSIONS: The outcomes of both strategies showed satisfactory results in our study. Consequently, surgeons may choose between the two strategies according to their preference and skill. The two approaches only differed with regard to vaginal scarring. We suggest future research investigating the long-term impact of scarring.

Preclinical safety testing and initial experience of a morcellation bag with four sealable ports.

Electromechanical morcellation-so called power morcellation-is a minimally invasive approach to remove bulky lesions such as uterine fibroids. The spread of benign and malignant tissue due to morcellation is a major concern that might limit the use of laparoscopic interventions. We present an in vitro evaluation of the safety characteristics of a four-port endobag with closable trocar sleeves, and describe physical properties of the bag that may or may not allow passage through the hole. In addition, we report our preliminary experience of this tool when used for laparoscopic supracervical hysterectomies. The behavior of the endobag during the extraction process was analyzed by extracting opened and re-sealed bags filled with 20 ml blue dye solution through a wooden template, with incisions measuring 10 to 24 mm. The endobag was used in 50 subtotal hysterectomies during the morcellation procedure. In the in vitro test, no dye loss was recorded for incisions measuring 11-24 mm. The mean force required to pull the bag through the template was inversely proportional to incision size. No bag rupture occurred during the surgical procedures. The mean time taken to prepare the bag for morcellation was 7.1 min (range, 4-14 min), the mean duration of subtotal hysterectomy was 53.4 min (range, 20-194 min). The mean weight of the removed body of the uterus was 113.8 g (range, 13-896 g), the mean weight of tissue and fluid remaining in the bag after morcellation 7.9 g (range, 0-39 g). In the in vitro setting, the improved endobag signifies greater patient safety during bag extraction, along with less tissue traumatization due to a smaller incision in the abdominal wall. The improved ergonomic features of the bag permit the insertion of three trocars in the lower abdomen and avoid closure of unused access ports. Our preliminary experience has shown that the device can be used under routine conditions. Failure rates will be evaluated in future studies.

Prospective International Multicenter Pelvic Floor Study: Short-Term Follow-Up and Clinical Findings for Combined Pectopexy and Native Tissue Repair.

Efforts to use traditional native tissue strategies and reduce the use of meshes have been made in several countries. Combining native tissue repair with sufficient mesh applied apical repair might provide a means of effective treatment. The study group did perform and publish a randomized trial focusing on the combination of traditional native tissue repair with pectopexy or sacrocolpopexy and observed no severe or hitherto unknown risks for patients (Noé G.K. J Endourol 2015;29(2):210-5.). The short-term follow-up of this international multicenter study carried out now is presented in this article. MATERIAL AND METHODS: Eleven clinics and 13 surgeons in four European counties participated in the trial. In order to ensure a standardized approach and obtain comparable data, all surgeons were obliged to follow a standardized approach for pectopexy, focusing on the area of fixation and the use of a prefabricated mesh (PVDF PRP 3 × 15 Dynamesh). The mesh was solely used for apical repair. All other clinically relevant defects were treated with native tissue repair. Colposuspension or TVT were used for the treatment of incontinence. Data were collected independently for 14 months on a secured server; 501 surgeries were registered and evaluated. Two hundred and sixty-four patients out of 479 (55.1%) returned for the physical examination and interview after 12-18 months. MAIN OUTCOME AND RESULTS: The mean duration of follow-up was 15 months. The overall success of apical repair was rated positively by 96.9%, and the satisfaction score was rated positively by 95.5%. A positive general recommendation was expressed by 95.1% of patients. Pelvic pressure was reduced in 95.2%, pain in 98.0%, and urgency in 86.0% of patients. No major complications, mesh exposure, or mesh complication occurred during the follow-up period. CONCLUSION: In clinical routine, pectopexy and concomitant surgery, mainly using native tissue approaches, resulted in high satisfaction rates and favorable clinical findings. The procedure may also be recommended for use by general urogynecological practitioners with experience in laparoscopy.

Laparoscopic approaches to the retropubic space: three alternatives with anatomical considerations.

INTRODUCTION: Many urogynecological and surgical laparoscopic interventions require access to the retropubic space, also known as the space of Retzius. Especially in patients with a history of previous surgery in this area or in general in the lower abdomen, the preparation may be complicated by adhesions and scar tissue. The necessity to combine several laparoscopic procedures in one surgical session may require consideration of the most appropriate way to approach the retropubic space. MATERIAL AND METHODS: We describe and discuss three different options to access the space of Retzius via laparoscopy: the medial transperitoneal, the extraperitoneal and the lateral transperitoneal approach. For all approaches, we used one umbilical trocar and two trocars in the lower abdomen. RESULTS: An algorithm was developed to select the most appropriate access route to the retropubic space, depending on the history of previous surgeries and accompanying interventions. CONCLUSION: The knowledge of different access routes to the retropubic space offers the possibility of adjusting the surgical procedure to the individual constellation of the patient.

Prospective international multicenter pectopexy trial: Interim results and findings post surgery.

The technique of laparoscopic pectopexy was published in 2010. A subsequent randomized trial focused on pectopexy versus sacropexy revealed no new risks for patients and significant advantages in terms of operating time and de novo defecation disorders compared to sacrocolpopexy. The present international multicenter trial was performed to evaluate the applicability of the technique in clinical routine. MATERIAL AND METHOD: Eleven clinics and 13 surgeons in four European counties participated in the trial. To ensure a standardized approach and obtain comparable data, all surgeons followed the same rules in placing the apical tape, no further mesh was used. Data were collected for 14 months on a secured server; 501 surgeries were documented and evaluated. RESULTS: Patients treated at the leading center (2 surgeons) contributed 44 % of the patient population. We made a distinction between high-volume (48-135 surgeries annually) (n = 4), intermediate-volume (28-37 surgeries annually) (n = 4), and low-volume (7-22 surgeries annually) (n = 5) surgeons. 97.3 % of the patients (n = 501) had delivered children; 5.6 % had had a Caesarian section. 29.7 % of the patients had undergone a hysterectomy. The operating time for pectopexy was less than 60 min in 79 % of cases. The procedures were completed in less than 159 min in 71 % of cases. Severe complications (n = 5) included four cases of organ damage (related to concomitant surgeries or adhesions) and one case of relevant bleeding. De novo incontinence was registered in two cases and voiding dysfunction in three. No intestinal obstruction or defecation disorder was observed. Two complicated infections were noted. Urinary infection occurred in 2 % of patients. CONCLUSION: In clinical routine severe complications occurred in 1 %. The latter were unrelated to pectopexy, but occurred due to concomitant procedures or adhesions. The overall operating time as well as the operating time for pectopexy were similar to those reported in published studies on sacrocolpopexy.