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

Journal Pre-proof Prospective international multicenter pectopexy trial: interim results and findings post surgery ´ Sven Schiermeier, Thomas Papathemelis, Ulrich Gunter ¨ K. Noe, Fuellers, Alexander Khudyakov, Harald-Hans Altmann, Stefan Borowski, Pawel P. Morawski, Markus Gantert, Bart De Vree, Tkacz Zbigniew, Rodrigo Gil Ugarteburu, Michael Anapolski

PII:

S0301-2115(19)30478-6

DOI:

https://doi.org/10.1016/j.ejogrb.2019.10.022

Reference:

EURO 11025

To appear in: Biology

European Journal of Obstetrics & Gynecology and Reproductive

Received Date:

11 August 2019

Revised Date:

10 October 2019

Accepted Date:

17 October 2019

Please cite this article as: Noe´ GK, Schiermeier S, Papathemelis T, Fuellers U, Khudyakov A, Altmann H-Hans, Borowski S, Morawski PP, Gantert M, De Vree B, Zbigniew T, Ugarteburu RG, Anapolski M, Prospective international multicenter pectopexy trial: interim results and findings post surgery, European Journal of Obstetrics and amp; Gynecology and Reproductive Biology (2019), doi: https://doi.org/10.1016/j.ejogrb.2019.10.022

This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier.

Prospective international multicenter pectopexy trial: interim results and findings post surgery Günter K. Noé, MD Phd1, Sven Schiermeier, MD Phd2, Thomas Papathemelis MD3, Ulrich Fuellers, MD4, Alexander Khudyakov4, Harald-Hans Altmann, MD5, Stefan Borowski MD6,

Phd10, Rodrigo Gil Ugarteburu MD11, Michael Anapolski, MD1

University of Witten-Herdecke, Department of Obstetrics and Gynecology,

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Pawel P. Morawski MD7, Markus Gantert MD. Phd8, Bart De Vree MD9, Tkacz Zbigniew MD

District Hospital Dormagen, Germany

Department of Obstetrics and Gynecology, University Witten-Herdecke, Germany.

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Department of Obstetrics and Gynecology, St. Marien Hospital Amberg, Germany

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Private Department of surgical Gynecology, Krefeld (GTK) Germany

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Department of Obstetrics and Gynecology, Regiomed Clinics Coburg, Germany

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Department of Obstetrics and Gynecology, Clinic Links der Weser, Bremen

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Germany

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Department of Obstetrics and Gynecology, Helios Clinic Bad Sarow, Germany

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Department of Obstetrics and Gynecology, St Franziskus Hospital Ahlen, Germany

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Department of Obstetrics and Gynecology, ZNA Middelheim Antwerp, Belgium

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Department of Obstetrics and Gynecology, NHS Tayside Dundee, Scotland

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Department of Obstetrics and Gynecology, University Hospital de Cabueñes

Gijon, Spain

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Corresponding Author: Sven Schiermeier, MD Phd

Thomas Papathemelis MD

Distrikt Hospital Dormagen

Marien-Hospital

Klinikum St. Marien Amberg

Dr. Geldmacherstr. 20

Witten Marienplatz

Mariahilfbergweg 7

41539 Dormagen, Germany

258452 Witten

92224 Amberg

Tel.: +49 2133 662601

Tel.: +49 2302 173 1323

Tel.: +49 9621 38-5547

Fax: +49 2133 662603

Fax: +49 2302 173 1325

Fax: +49 9621 38-1358

[email protected]

[email protected]

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Guenter Karl Noé, MD, Phd

papathemelis.thomas@klinikum-

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amberg.de

Alexander Khudyakov

Harald-Hans Altmann, MD

GTK Krefeld

GTK Krefeld

Klinikum Coburg GmbH,

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Violstrasse 92

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Ulrich Fuellers, MD

Violstrasse 92

Ketschendorfer Str. 33,

47800 Krefeld

D - 96450 Coburg

Tel.: 02151 – 80600

Tel.: +49 9561 22-0

Fax: +492151 - 806080

Fax: 02151 – 806080

Fax: +49 9561 22-7220

[email protected]

[email protected]

harald-hans.altmann@klinikum-

47800 Krefeld

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Tel.: +492151 – 80600

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coburg.de

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Stefan Borowski MD

Pawel P. Morawski MD

Markus Gantert MD. Phd

Klinikverbund Bremen

Helios Klinikum Bad Saarow

St. Franziskus-Hospital Ahlen

Senator-Weßling-Straße 1

Pieskower Straße 33

Robert-Koch-Str. 55

28277 Bremen

15526 Bad Saarow

59227 Ahlen

Tel.: +49421 879 0

Tel.: +49 33631 7-2288

Tel.: + 49 2382 - 858 433

Fax: +49421 879 1599

Fax: +49 33631 7-2108

Fax:

stefan.borowski@klinikum-bremen-

pawel.morawski@helios-

[email protected]

ldw.de

gesundheit.de

Bart De Vree MD

Tkacz Zbigniew MD PhD

ZNA Campus Middelheim

NHS Tayside Ninewells

Clínica Asturias

Lindendreef 1

Hospital

Calle Naranjo de Bulnes, 4

2020 Antwerpen

DD1 9SY Dundee

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Rodrigo Gil Ugarteburu MD

33012 Oviedo

Tel.: +44 1382 632089

Tel.: +34 985 286 000

Fax: +44 1382 613552

Fax:

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[email protected]

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Tel.: +32 03 280 30 03

+ 49 2382 - 858 322

[email protected]

[email protected]

Michael Anapolski, MD

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Distrikt Hospital Dormagen Dr. Geldmacherstr. 20

41539 Dormagen, Germany Tel.: +49 2133 662601 Fax: +49 2133 662603 [email protected]

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Abstract: 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

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applicability of the technique in clinical routine.

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Material and Method

Eleven clinics and 13 surgeons in four European counties participated in the trial. To ensure a

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standardized approach and obtain comparable data, all surgeons followed the same rules in

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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.

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Results:

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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%

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of the patients had undergone a hysterectomy. The operating time for pectopexy was less than 60 minutes in 79% of cases. The procedures were completed in less than 159 minutes 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 4

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

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the operating time for pectopexy were similar to those reported in published studies on

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sacrocolpopexy.

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Introduction:

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Keywords: prolapse; laparoscopic surgery; multicenter, pectopexy

Given the controversial discussions on the numerous complications of mesh placement and the

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paucity of study data on the subject, laparoscopic techniques of prolapse surgery are attracting increasing attention. Apical support is a cornerstone of prolapse surgery, and sacral colpopexy the most frequently used technique in laparoscopy. In view of the disadvantages of the approach, we

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devised the procedure of laparoscopic pectopexy in 2007 [1]. The success of sacral colpopexy became evident in 1962 when Lane first used alloplastic material for the interposition between vagina and the sacrum. The method provided a natural vaginal axis with a low level of tension for the suspension [2]. Several modifications of the technique were described subsequently. Based on extensive data and the favorable outcome of the technique, it is now accepted as the “gold standard” in prolapse surgery around the world [3-5]. 5

In the early 1990’s Nezhat and Dorsey reported the first laparoscopic adaptation of the technique. The surgeons placed the interpositioned material at the level of the second sacral vertebra to achieve the normal vaginal axis known from open surgery [6, 7]. The difficulty of the access has led surgeons to now use the promontory for cranial fixation. A variety of approaches are currently in use and the results are difficult to compare. We make a

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distinction between two surgical approaches. One is the defect-oriented strategy in which apical support is provided by sacral colpopexy, whereas other defects are treated by additional

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approaches such as coloporraphy or lateral defect repair. The second strategy is to manage all

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defects collectively by using extended Y-shaped meshes which are placed posteriorly and anteriorly over the entire length of the vagina, as deeply as possible [5, 8-12].

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The majority of the studies have been performed at a single center. They provide excellent long-

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term results, but a variety of side effects have been noted. Data concerning de novo SUI vary considerably (7-50%). Although defecation disorders are a well-known phenomenon, hardly any

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study has focused on this problem. Restriction of the pelvis by the interpositioned material and the affliction of the hypogastric plexus were identified as the main reasons for defecation disorders [13].

According to published data, de novo defecation disorders may be anticipated in 17-34% of cases

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after the procedure [3, 4, 14-16]. Slow intestinal transit, chronic flatulence, pain during defecation, and mild to severe constipation are the main symptoms reported in the published literature.

Obesity is associated with narrow conditions in the pelvis due to fatty tissue or a stiff rectum caused by diverticulosis or diverticulitis in the patient’s history. A reduced intestinal passage is 6

disadvantageous in a patient with the latter condition. We were able to reduce de novo SUI rates to 7% by combining colposuspension and sacral colpopexy when the patient had any type of SUI in the past or at the present time [17]. To eliminate the risk of narrowing the pelvic space during surgery and harming the hypogastric plexus, we developed pectopexy in 2007 [1]. Since the tape for the apical support is fixed bilaterally at the pectineal ligament, it does not harm the rectum or the hypogastric plexus. The tape is placed in an organ-free area and the defined fixation point

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provides a natural vaginal axis.

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In a previous randomized trial (Pectopexy versus Sacral Colpopexy S2) we showed the

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equivalent efficacy of the technique. No new risks were encountered during surgery or in the follow-up period (19-21 months). The study was performed in a multiple compartment setting,

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combining different laparoscopic and vaginal approaches with apical fixation by pectopexy [18,

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19].

The data obtained in the preliminary randomized trial were collected by two very experienced

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surgeons. The next step was to establish the applicability of the technique in clinical routine, which necessitated a multicenter trial. Material and Methods:

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The study was conducted at 11 clinics by 13 surgeons in four European counties. All surgeons were trained by the leading center in order to ensure a standardized approach and obtain comparable data. Data were collected on a secured server at the University of Wuerzburg, which served as an online database for each center. Each surgeon had a private access to the data base and added the data of each patient after surgery and the latest data 3 weeks after surgery. The defects were staged according to the Baden-Walker classification from grades 1 to 4. We made a 7

distinction between apical defects, cystocele midline, cystocele lateral defects, and posterior defects. Leading complaints such as pelvic pressure, SUI, urgency, stool bulking, pain, and sexual impairment were documented in addition to obstetric data and the patients’ history of previous surgery, especially hysterectomy and Caesarean sections. Additional approaches, whether by the vaginal or the laparoscopic approach, were registered in

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order to document the strategy used at each center. The total operating time (including all concomitant surgeries) as well as the time taken for pectopexy were noted. Intraoperative

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complications and postoperative data such as the duration of the hospital stay, early- and late-

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onset infection (14 days after surgery), wound infection, etc. were collected on the database. We collected data for 14 months and documented the treatment of 501 patients. One surgeon

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registered only two cases and then closed the database, although he had operated 37cases. The

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two cases were included in the evaluation because one of these involved a major complication. Statistical evaluation was performed using IBM SPSS statistics.

156/2017). Results:

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Ethics approval was provided by the University of Witten Herdecke (Approval number

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501 data records were available for statistical analysis. A typical Gauss curve was noted in regard of age for all centers. (Figure 1)

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Although 44% of the patients (n=501) were treated at the leading center, the distribution of highvolume (48-135 surgeries p.a.) (4), intermediate-volume (28-37) (4), and low-volume (7-22) (5) surgeons was quite even. 96% (466) of the patients had delivered children; 5.6% (26) of them had had a Caesarian section in the past. 19.1% of women had delivered one infant in the past, 47.7% had delivered two infants, and 18.4% had delivered three infants (8.8% had had 4-6 deliveries /

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6% none). 29.7% (149) of the patients had undergone a previous hysterectomy. Total hysterectomies had

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been performed in 81.3 % (121) and subtotal hysterectomies by laparoscopy in 18.7% (28). The

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total hysterectomies were largely performed by the vaginal route (67%), followed by laparotomy in 31.2% and TLH in 1.8%.

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Table 2 shows the leading symptoms caused by prolapse; bulging and pelvic pressure were

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predominant.

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Twenty-four percent of the patients reported SUI prior to the surgery. SUI grade 1 was noted in 25 %, grade 2 in 66%, and grade 3 in 9% of incontinent patients. All centers followed the multiple compartment approach, but the sum of concomitant surgeries

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differed; this had an impact on operating times.

As many as five additional surgeries were performed in some cases. Only one center combined 5 further approaches in 2% of cases. Four were added at 4 centers in 4-8% of cases. Six of 11 centers combined three additional approaches with pectopexy. All 11 centers offered a strategy 9

combining apical fixation with one or two additional approaches. In 10% of the cases a pectopexy alone was performed. The range of combined surgeries correlated with the total volume (experience) at each center and had a predictable impact on operating times (Figure 3).

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Operating time: Operating time varied between the hospitals and depended on the sum of concomitant

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approaches. A linear model for operating times and the number of surgical approaches and

centers as factors suggest differences across centers (F-change test: 34.64, Dfl;10.Df2: 475,

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p<0,001).

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Assuming a linear increase in operating time with increasing numbers of surgical approaches, the

confidence interval 23.8;31.7].

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estimated increase for one additional technique after adjustment for centers is 27.8 minutes [95%

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The mean operating time over all centers with reference to the total length of the procedures was 135 minutes (standard deviation 46.08). The mean operating time for pectopexy alone was

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46.21(standard deviation 18.47).

Complications:

Table 4 summarizes the complications after surgery. Five complications were severe (1.0%). One case of bleeding in excess of 500 ml and four instances of organ damage were noted; these were managed during the procedure. Organ damage was never related to pectopexy, but to concomitant

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approaches or the management of adhesions. Three bladder lesions were treated by a suture, and in one case a ureter was stented and superficially sutured after adhesiolysis.

Discussion:

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We have been performing pectopexy from 2007 onward. In a randomized trial we were able to establish the safety and effectiveness of the procedure compared to sacral colpopexy [18, 19].

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Since the current database is founded on the results obtained at a highly specialized center, we wished to establish whether the results could be applied in clinical routine. The fixation of several

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defects in a single session calls for a high level of surgical skill. Therefore, only experienced

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surgeons who had performed a large number of operations were included in this prospective multicenter trial. To ensure the comparability of data and a standardized approach, all surgeons

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had been trained at workshops conducted by the leading center. A sophisticated strategy of combined surgical procedures is needed to minimize the use of

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interpositioned material. Most centers use a Y-shaped mesh for sacrocolpopexy. The tape should be placed as deeply as possible [20]. The studies cannot be easily compared because the fixation techniques, the use of meshes, and concomitant surgeries vary considerably between centers [21,

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22]. A small number of prospective multicenter trials exist. One study with a small patient sample showed a better postoperative outcome for the laparoscopic procedure [23]. Nosti et al. reported on a large sample (1124) in a retrospective multicenter analysis spanning a period of two years, focusing on complications and short-term outcomes [24]. In accordance with our definition of complications, the authors registered complications in 16.3% of the abdominal group and 9.4%

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of the endoscopic group. We observed perioperative complications in 4.2%. A head-to-head comparison of severe complications is shown in Table 4.

The rate of severe complications was low in our trial. Due to the position of the pectopexy tape there is no risk of intestinal obstruction. The multi-compartment strategy allows the surgeon to

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desist from dissecting non-compromised areas. This may reduce bladder and bowel injury as

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well. Another explanation for the low complication rate is the selection and training of surgeons, as we did not want to measure early learning curves. All surgeons had performed a minimum of

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10 procedures prior to the study and were experienced in performing laparoscopic procedures.

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Nosti et al. report a mean operating time of 272 minutes (range, 94-451 minutes) for LSK. Moore et al. report a mean operating time of 160.13 minutes for combined sacropexy and concomitant

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surgeries. Sacropexy alone took 52.78 ± 13.09 minutes. To our knowledge, Moore et al. have reported the shortest operating time in the published literature [12]. After adjusting the

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differences in our study group, the mean operating time over all centers for the entire procedure was 135 minutes (±46.08). The mean duration of pectopexy alone was 46.21minutes (±18.47). The data of our multicenter trial are similar to the single-center retrospective evaluation at this center of excellence (Moore). As Figure 4 shows, there is a linear increase in operating time at

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each center with every additional approach. Figure 4 also shows the association between the volume of surgery and operating time. The operating times and complication rates registered in the present study are similar to the data reported from retrospective single-center or multicenter trials. Follow-up data (12-14 months)are

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currently awaited, but the results of the randomized trial [19] warrant favorable outcomes in the long term as well.

Conclusion:

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Pectopexy and the multiple compartment approach can be transferred to clinical routine. The low complication rates bear evidence of the safety of the approach. A clearly defined surgical

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procedure as well as standardized and controlled training for surgeons ensure a high standard of treatment for patients. Given these conditions, the procedure may be recommended for use in

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Disclosure Section:

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Word count: Abstract: 300; Text: 2346

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clinical routine.

Guenter K. Noé is Consultant for BOWA-electronic GmbH & Co and FEG Textile-Technique (no payment/ accommodation and travel expenses for company related presentations)

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Michael Anapolski is Consultant for BOWA-electronic GmbH & Co and FEG Textile-Technique (no payment/ accommodation and travel expenses for company related presentations) Prof. Dr. Sven Schiermeier, Dr. Thomas Papathemelis, Dr. Ulrich Fuellers, Alexander Khudyakov, Dr. Harald-Hans Altmann, Dr. Stefan Borowski, Dr. Pawel P. Morawski, Dr.

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Markus Gantert, Dr. Bart De Vree, Dr. Tkacz Zbigniew and Dr. Rodrigo Gil Ugarteburu have no

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conflicts of interest or financial ties to disclose.

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Legends:

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Figure 1: Age distribution over all centers

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Figure 2: Contribution of 13 surgeons (surgeon 1-13 / surgeries performed)

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Figure 3: Operating times and the sum of interventions at the centers

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Figure 4: Estimated operating time by centers dependent on sum of surgical approaches

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Frequency

Percent

Cumulative %

1 2 3 4 5 6 7 8 9 10 11 Total

72 28 28 11 64 35 225 2 (documented of 37) 20 9 7 501

14.3 5.58 5.58 2.2 12.77 7.0 44.9 0.4 4.0 1.8 1.4

14.3 19.9 25.5 27.7 40.5 47.5 92.4 92.8 96.8 98.6 100

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Center

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Table 1: Contribution of 11 centers; centers 1 and 7 had two surgeons each

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Complaints/Symptoms

%

Pelvic pressure / bulging Urgency SUI Pain Sexual impairment Stool bulking

92.8 47.7 23.9 20.5 17.5 8.5

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Table 3: Concomitant surgeries performed in the study

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Percentage 100 34.5 26.3 13.6 11.8 31.7 12.8 0.4 0

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Pectopexy Laparoscopic cystocele repair Laparoscopic posterior repair Vaginal anterior repair Vaginal posterior repair Laparoscopic lateral repair Burch colposuspension Vaginal tape Bulking agent

Frequency 501 173 132 68 59 159 64 2 0

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Table 2: Ranking of preoperative symptoms

Count 5 (1>500ml) 4 0 2

% 1.0 0.8 0.0 0.4

0 3 10

0.0 0.6 2.0

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0.4 5.2

Complication Bladder injury Ureter injury Ileus Bowel injury Hemorrhage >500

Nosti et al. n =535 (mic) 2.0% 0.0% 2.0% 0.7% 1.1%

Own data n=501 0,6% 0,2% 0.0% 0.0.% 0.2%

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Complication Blood loss >200ml Organ damage Intestinal obstruction De novo incontinence (post op.) Constipation Voiding dysfunction Urinary infection (incl. 14 days after surgery) Infection

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Table 4: Complications during surgery or 14 days post-surgery(n=501) Severe complications compared to the multicenter data reported by Nosti et al.

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