慧润康(北京)科贸有限公司

Prospective International Multicenter Pelvic Floor Study: Short-Term Follow-Up and Clinical Findings

发表时间:2021-08-17 15:21

NOE 髂耻_页面_02222.jpg


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


xyyl_xj@126.com
400-110-9995
北京市丰台区纪通东路78号院泰合嘉办公楼4层
邮箱:
电话:
地址: