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Abstract
Since the restriction on the introduction of mesh prostheses in pelvic floor surgery, there has been a need to perform effective and reliable surgical interventions using other implants for the repair of pelvic organ prolapse. The possibility of using xenopericardial plates in gynecological practice remains a significant issue and represents a medical area of current interest for research.
The purpose of the study is to evaluate the effectiveness and safety of using xenogeneic biomaterial for the correction of anterior-apical POP in women.
Materials and methods. The study was conducted on the basis of the gynecological department N 2 of the Clinical Hospital named after S.V. Belyaev. The design of the study is prospective, observational. The study included 10 postmenopausal women admitted for planned surgical treatment with anterior-apical POP. The average age of the patients was 62.0 ± 4.9 years. All patients underwent surgical treatment of anterior-apical POP according to the author's technique (patent application N 2024109896 dated April 11, 2024) using xenogeneic biological material of the KemPlas surgical universal xenopericardial mesh. The effectiveness and safety of the use of the author's technique were assessed 7 days, 1 month and 6 months after surgical treatment. The primary outcome is the presence of complications of surgical treatment (implant rejection), the secondary outcome is relapse of POP.
Results. During follow-up for 6 months, relapse of POP was not found in any patient. Infectious complications occurred in 4 patients (40 %). Implant rejection occurred in 4 (70 %): after 1 month – in two women (20 %), after 3 months – in 4 (40 %), in 1 (10 %) woman – after 5 months. In 3 (30 %) women, the postoperative period passed without complications: no inflammatory reactions, migration, or implant rejection were detected. These patients were 58, 65 and 70 years old; two older patients received long-term local estrogen therapy. The patients had no sexual activity, no heavy physical labor, and had normal body weight.
Conclusions. Thus, the use of xenogeneic biomaterial for the correction of anterior-apical pelvic organ prolapse in women has a high incidence of implant migration and rejection. Further studies of the effectiveness of the use of this biomaterial are possible only in patients with no provoking factors (sexual activity, obesity, heavy physical labor, etc.) and after adequate preoperative preparation with local estriol preparations.
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Weintraub AY, Glinter H, Marcus-Braun N. Narrative review of the epidemiology, diagnosis and pathophysiology of pelvic organ prolapse. Int Braz J Urol. 2020; 46(1): 5-14. doi: 10.1590/S1677-5538.IBJU.2018.0581
American College of Obstetricians and Gynecologists and the American Urogynecologic Society; INTERIM UPDATE: This Practice Bulletin is updated as highlighted to reflect the US Food and Drug Administration order to stop the sale of transvaginal synthetic mesh products for the repair of pelvic organ prolapse.. Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2019; 25(6): 397-408. doi: 10.1097/SPV.0000000000000794
Bezhenar VF, Derii EK, Ivanov OA, Azhimova ShM, Palastin PM. Markers of connective tissue dysfunction in the aspect of surgical treatment of pelvic organ prolapse. Issues of gynecology, obstetrics and perinatology. 2020; 19(6): 90-95. Russian (Беженарь В.Ф., Дерий Э.К., Иванов О.А., Ажимова Ш.М., Паластин П.М. Маркеры дисфункции соединительной ткани в аспекте хирургического лечения пролапса тазовых органов //Вопросы гинекологии, акушерства и перинатологии. 2020. Т. 19, № 6. С. 90-95.) doi: 10.20953/1726-1678-2020-6-90-95
Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2016; 11(11): CD004014. doi: 10.1002/14651858.CD004014.pub6
Lau HH, Davila GW, Chen YY, Sartori MGF, Jármy-Di Bella ZIK, Tsai JM, et al. FIGO recommendations: Use of midurethral slings for the treatment of stress urinary incontinence. Int J Gynaecol Obstet. 2023; 161(2): 367-385. doi: 10.1002/ijgo.14683
Dieter AA. Pelvic Organ Prolapse: Controversies in Surgical Treatment. Obstet Gynecol Clin North Am. 2021; 48(3): 437-448. doi: 10.1016/j.ogc.2021.05.001
Rice NT, Hu Y, Slaughter JC, Ward RM. Pelvic mesh complications in women before and after the 2011 FDA public health notification. Female Pelvic Med Reconstr Surg. 2013; 19(6): 333-338. doi: 10.1097/SPV.0b013e3182a330c1
Min H, Li H, Bingshu L, Yanxiang C, Lu C, Qing S, et al. Meta-analysis of the efficacy and safety of the application of adjuvant material in the repair of anterior vaginal wall prolapsed. Arch Gynecol Obstet. 2013; 287(5): 919-936. doi: 10.1007/s00404-012-2626-6
Silva-López MS, Alcántara-Quintana LE. The Era of Biomaterials: Smart Implants? ACS Appl Bio Mater. 2023; 6(8): 2982-2994. doi: 10.1021/acsabm.3c00284
Uchida T, Hamasaki A, Kuroda Y, Yamashita A, Nakai S, Kobayashi K, Sadahiro M. Gerbode defect and left ventricular-aortic discontinuity in prosthetic valve endocarditis. J Artif Organs. 2020; 23(3): 288-291. doi: 10.1007/s10047-019-01153-z
Merriman AL, Kennelly MJ. Biologic Grafts for Use in Pelvic Organ Prolapse Surgery: a Contemporary Review. Curr Urol Rep. 2020; 21(12): 52. doi: 10.1007/s11934-020-01013-x
Bashkov VA, Nikolsky AV, Mikheev VV. Use of xenopericardium in the surgical treatment of stress urinary incontinence. New tasks of modern medicine: Proceedings of the II Intern. Scient. Conf., St. Petersburg, 20-23 May 2013. St. Petersburg: Renome, 2013. P. 33-36. Russian (Башков В.А., Никольский А.В., Михеев В.В. Применение ксеноперикарда в хирургическом лечении стрессового недержания мочи //Новые задачи современной медицины: Матер. II Междунар. науч. конф., Санкт-Петербург, 20-23 мая 2013 года. СПб.: Реноме, 2013. С. 33-36)
Shinkarev SA, Latyshev YuP, Klycheva ON. Reconstruction of the pelvic floor with xenopericardial tissue. Research'n Practical Medicine Journal. 2018; 2: 77. Russian (Шинкарев С.А., Латышев Ю.П., Клычева О.Н. Реконструкция тазового дна ксеноперикардиальной тканью //Research'n Practical Medicine Journal. 2018. № 2. С. 77)
Selikhova MS, Ershov GV, Ershov AG. Pelvic organ prolapse is a hidden epidemic of the 21st century. Advances in gerontology. 2021; 34(3): 431-437. Russian (Селихова М.С., Ершов Г.В., Ершов А.Г. Пролапс тазовых органов скрытая эпидемия XXI века //Успехи геронтологии. 2021. Т. 34, № 3. С. 431-437.) doi: 10.34922/AE.2021.34.3.013
Sohlberg EM, Dallas KB, Weeks BT, Elliott CS, Rogo-Gupta L. Reoperation rates for pelvic organ prolapse repairs with biologic and synthetic grafts in a large population-based cohort. Int Urogynecol J. 2020; 31(2): 291-301. doi: 10.1007/s00192-019-04035-3
