Prospective International Multicenter Pelvic Floor Study: Short-Term Follow-Up and Clinical Findings发表时间:2021-08-17 15:21 Prospective International Multicenter Pelvic Floor Study: Short-Term Follow-Up and Clinical Findings for Combined Pectopexy and Native Tissue Repair Günter K. Noé 1,*, Sven Schiermeier 2, Thomas Papathemelis 3, Ulrich Fuellers 4, Alexander Khudyakovd 4,HaraldHans Altmann 5, Stefan Borowski 6, Pawel P. Morawski 7, Markus Gantert 8,Bart De Vree 9,Zbigniew Tkacz 10, Rodrigo Gil Ugarteburu 11 and Michael Anapolski 1 1 Department of Obstetrics and Gynecology, University of WittenHerdecke, Rheinlandclinics Dormagen,41540 Dormagen, Germany; michael.anapolski@kkh-ne.de 2 Department of Obstetrics and Gynecology, University Witten-Herdecke, 258452 Witten, Germany; sven.schiermeier@uni-wh.de 3 Department of Obstetrics and Gynecology, St. Marien Hospital Amberg, 92224 Amberg, Germany; papathemelis.thomas@klinikum-amberg.de 4 Private Department of Surgical Gynecology, Krefeld (GTK) Germany, 47800 Krefeld, Germany; fuellers@gtk-krefeld.de (U.F.); Khudyakovd@gtk-krefeld.de (A.K.) 5 Department of Obstetrics and Gynecology, Regiomed Clinics Coburg, 96450 Coburg, Germany; harld-hans.altmann@klinikum-coburg.de 6 Department of Obstetrics and Gynecology, Clinic Links der Weser, Bremen, 28277 Bremen, Germany; Stefan-Borowski@klinikum-bremen-ldw.de 7 Department of Obstetrics and Gynecology, Helios Clinic Bad Sarow, 15526 Bad Saarow, Germany; Pawel.Morawski@helios-gesundheit.de 8 Department of Obstetrics and Gynecology, St Franziskus Hospital Ahlen, 59227 Ahlen, Germany; Markus.Gantert@gmail.com 9 Department of Obstetrics and Gynecology, ZNA Middelheim Antwerp, 2020 Antwerpen, Belgium; dr.devree@praktijkdevree.net 10 Department of Obstetrics and Gynecology, NHS Tayside Dundee, DD1 9SY Dundee, Scotland; ztkacz@nhs.net 11 Departmentof Obstetrics and Gynecology, University Hospital de Cabueñes, 33394 Gijon, Spain; guerillas3@hotmail.com * Correspondence: g.noe2013@gmail.com Abstract: 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 Europeancounties 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 wassolely 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. Keywords: prolapse; pelvic floor; laparoscopy; native tissue; pectopexy 1. Introduction Due to controversies about the use of meshes, native tissue repair in pelvic surgery has currently rebecome the matter of choice in several countries. Native tissue repair was considered to be insufficient for a long period of time. However, several publications have shown that, from a clinical perspective, it provides better outcomes than meshes in the long term. In fact, the patients’ symptoms are improved to a much greater extent compared to the assessment of the sheer anatomical results [1–3]. Various vaginal or abdominal techniques (Manchester; sacrospinous fixation; high uterosacral fixation etc.) have been suggested for the restoration of apical support. To date, we lack validated data about the adequacy of these approaches. Sacral colpopexy with mesh is a frequently used technique in laparoscopy and has been evaluated in several studies. Due to the disadvantages of the approach (see below), our group devised the procedure of laparoscopic pectopexy in 2007 [4]. The so-called gold standard of laparoscopic sacral colpopexy (LSC) is based on several decades of extensive experience. The introduction of alloplastic material to fill the gap between the vagina and the sacrum accelerated the acceptance of the technique [5]. Extensivedata have been reported from singlecenter studies, but a prospective multicenter trialcomparing access and quality has not been published so far [6–8]. LSC commonly employs a y-shaped mesh deeply covering the total posterior length of the vagina and the anterior wall next to the bladder neck [9,10]. Comparison with publisheddata is rendered difficult by the manifold approaches currently in use. Therefore, our group did focus on the use of mesh material only for apical support and did repair other defects with native tissue strategies [11]. Using pectopexy as apical support in combination with native tissue may reduce the risk of defecation disorders, which occur frequently after LSC. Additionally, meshrelated problems such as exposure at the vaginal wall were reduced [12]. De novo defecation disorders are anticipated in 17–34% of cases after LSC [9,13–17]. Slow intestinal transit, chronic flatulence, pain during defecation, and mild to severe constipation are the main symptoms reported in the literature. Published data on pectopexy have indicated the benefits of offering a standardized alternative option to LSC with the potential of reducing the risk of defecation disorders and bowel constriction by the mesh material, especially in obese patients [12]. The combination of native tissue repair and sufficient apical support leads to a low rate of de novo stress urinary incontinence (SUI) (4.5–7%) as well as minimal use of mesh material [3,12].The present multicenter trial was performed to evaluate the effectiveness of the approachin general use by trained surgeons and determine the results of native tissue repair combined with apical mesh support in different hospitals and by different surgeons. 点击链接下载原文
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