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顧明軒 前瞻性國際多中心骨盆底器官脫垂研究:合併恥骨韌帶懸吊手術及自體組織修補手術之短期術後追蹤成果及臨床發現 2021/10/1 下午 02:44:09 0
原 文 題  目 Prospective International Multicenter Pelvic Floor Study: Short-Term Follow-Up and Clinical Findings for Combined Pectopexy and Native Tissue Repair
作  者 Günter K. Noé , Sven Schiermeier, Thomas Papathemelis, Ulrich Fuellers, Alexander Khudyakov, Harald-Hans Altmann, Stefan Borowski, Pawel P. Morawski, Markus Gantert, Bart De Vree, Zbigniew Tkacz, Rodrigo Gil Ugarteburu and Michael Anapolski
出  處 J. Clin. Med. 2021, 10, 217.
出版日期 9th January, 2021
評 論 鑑於近年國際間對於人工網膜應用於治療骨盆器官脫垂上的爭議,越來越多專家努力發展自體組織修補手術,或減少人工網膜於相關手術的使用量。傳統陰道頂端脫垂手術,是以薦骨陰道固定術(sacral colpopexy)為標準,但因使用人工網膜的面積較大,網膜固定於骨盆較深處,具有較高人工網膜曝露、術後排便相關症狀等風險。2007年,恥骨韌帶懸吊術(pectopexy)發表其臨床應用成效,對於治療陰道頂端脫垂的成果及安全性,至目前看起來是良好可接受的。此研究為國際多中心研究,探討採用較小面積人工網膜之腹腔鏡恥骨懸吊手術治療陰道頂端脫垂,同時視情況採用自體組織修補手術治療其他骨盆器官脫垂共病症,如尿失禁、膀胱脫垂、直腸脫垂等,發表目前病患之短期追蹤成果。總計有11家醫院,共13位婦女泌尿手術專家參與病患收案,所有手術皆依循標準原則進行。研究進行期間,共完成501例手術,其中共264位病患(55.1%)完成回診追蹤評估,平均追蹤時間為15個月。整體而言,對於陰道頂端脫垂,手術治療成功率為96.9%;病患正向滿意度為95.5%;同意推薦手術給親友的比例為95.1%。症狀方面,共95.2%手術病患感到術後骨盆壓力症狀改善;98.0%病患疼痛改善;86.0%病患急尿症狀改善。追蹤期間,沒有任何病患發生重大併發症、人工網膜曝露或相關併發症。整體而言,使用腹腔鏡恥骨韌帶懸吊術治療陰道頂端脫垂,同時使用自體組織修補手術於相關合併症,手術成效良好,且具高病患術後滿意度。
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 European counties 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 was solely 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.

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