Prospective international multicenter pectopexy trial: Interim results and findings post surgery
| Autor: | Sven Schiermeier, Pawel P. Morawski, Alexander Khudyakov, Bart De Vree, Rodrigo Gil Ugarteburu, Thomas Papathemelis, Markus Gantert, Michael Anapolski, Günter K. Noé, Tkacz Zbigniew, Ulrich Fuellers, Harald Hans Altmann, Stefan Borowski |
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| Rok vydání: | 2019 |
| Předmět: |
Laparoscopic surgery
medicine.medical_specialty medicine.medical_treatment Operative Time Pelvic Organ Prolapse law.invention 03 medical and health sciences 0302 clinical medicine Gynecologic Surgical Procedures Postoperative Complications Randomized controlled trial law Interim Multicenter trial medicine Humans 030212 general & internal medicine Prospective Studies 030219 obstetrics & reproductive medicine Hysterectomy business.industry Obstetrics and Gynecology Surgery Europe Reproductive Medicine Concomitant Defecation Female Caesarian section business |
| Zdroj: | European journal of obstetrics, gynecology, and reproductive biology. 244 |
| ISSN: | 1872-7654 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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