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

Günter K. Noé (Lead / Corresponding author), Sven Schiermeier, Thomas Papathemelis, Ulrich Fuellers, Alexander Khudyakov, Harald Hans Altmann, Stefan Borowski, Pawel P. Morawski, Markus Gantert, Bart De Vree, Tkacz Zbigniew, Rodrigo Gil Ugarteburu, Michael Anapolski

    Research output: Contribution to journalArticle

    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 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.

    Original languageEnglish
    Pages (from-to)81-86
    Number of pages6
    JournalEuropean Journal of Obstetrics and Gynecology and Reproductive Biology
    Volume244
    Early online date15 Nov 2019
    DOIs
    Publication statusPublished - Jan 2020

    Fingerprint

    Multicenter Studies
    Defecation
    Intestinal Obstruction
    Infection
    Hysterectomy
    Cesarean Section
    Hemorrhage
    Surgeons
    Population

    Keywords

    • Laparoscopic surgery
    • Multicenter
    • Pectopexy
    • Prolapse

    Cite this

    Noé, Günter K. ; Schiermeier, Sven ; Papathemelis, Thomas ; Fuellers, Ulrich ; Khudyakov, Alexander ; Altmann, Harald Hans ; Borowski, Stefan ; Morawski, Pawel P. ; Gantert, Markus ; De Vree, Bart ; Zbigniew, Tkacz ; Ugarteburu, Rodrigo Gil ; Anapolski, Michael. / Prospective international multicenter pectopexy trial : Interim results and findings post surgery. In: European Journal of Obstetrics and Gynecology and Reproductive Biology. 2020 ; Vol. 244. pp. 81-86.
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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 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.",
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    Noé, GK, Schiermeier, S, Papathemelis, T, Fuellers, U, Khudyakov, A, Altmann, HH, Borowski, S, Morawski, PP, Gantert, M, De Vree, B, Zbigniew, T, Ugarteburu, RG & Anapolski, M 2020, 'Prospective international multicenter pectopexy trial: Interim results and findings post surgery', European Journal of Obstetrics and Gynecology and Reproductive Biology, vol. 244, pp. 81-86. https://doi.org/10.1016/j.ejogrb.2019.10.022

    Prospective international multicenter pectopexy trial : Interim results and findings post surgery. / Noé, Günter K. (Lead / Corresponding author); Schiermeier, Sven; Papathemelis, Thomas; Fuellers, Ulrich; Khudyakov, Alexander; Altmann, Harald Hans; Borowski, Stefan; Morawski, Pawel P.; Gantert, Markus; De Vree, Bart; Zbigniew, Tkacz; Ugarteburu, Rodrigo Gil; Anapolski, Michael.

    In: European Journal of Obstetrics and Gynecology and Reproductive Biology, Vol. 244, 01.2020, p. 81-86.

    Research output: Contribution to journalArticle

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    T1 - Prospective international multicenter pectopexy trial

    T2 - Interim results and findings post surgery

    AU - Noé, Günter K.

    AU - Schiermeier, Sven

    AU - Papathemelis, Thomas

    AU - Fuellers, Ulrich

    AU - Khudyakov, Alexander

    AU - Altmann, Harald Hans

    AU - Borowski, Stefan

    AU - Morawski, Pawel P.

    AU - Gantert, Markus

    AU - De Vree, Bart

    AU - Zbigniew, Tkacz

    AU - Ugarteburu, Rodrigo Gil

    AU - Anapolski, Michael

    N1 - Copyright © 2019 Elsevier B.V. All rights reserved.

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    N2 - 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.

    AB - 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.

    KW - Laparoscopic surgery

    KW - Multicenter

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