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胡書維 腹腔鏡骶骨陰道固定術與陰道骶棘固定術治療陰道穹窿脫垂:一項隨機對照試驗和前瞻性世代研究(SALTO-2 試驗) 2023/6/15 上午 11:28:15 0
原 文 題  目 Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse: a randomised controlled trial and prospective cohort (SALTO-2 trial)
作  者 van Oudheusden AMJ, van IJsselmuiden MN, Menge LF, Coolen AWM, Veen J, van Eijndhoven HWF, Dietz V, Kluivers KB, Spaans WA, Vollebregt A, van de Pol G, Radder CM, van der Ploeg JM, van Kuijk SMJ, Bongers MY.
出  處 BJOG (British Journal of Obstetrics and Gynaecology). doi: 10.1111/1471-0528.17525.
出版日期 2023 May 2 (AoP)
評 論

中老年婦女因各項原因進行子宮全切除的比例不在少數,而其中因子宮全切除後發生陰道穹窿脫垂的比例亦高。根據之前文獻統計,因子宮脫垂行子宮全切除手術的病患陰道穹窿脫垂長期盛行率高達23%。針對陰道穹窿脫垂有許多治療方法,何者為較佳治療方式目前仍無定論。本文為比較腹腔鏡骶骨陰道固定術(LSC)與陰道骶棘固定術(VSF)在治療陰道穹窿脫垂上疾病相關生活品質和術後成功率等的臨床試驗和前瞻性世代研究,其中收錄病患為POP-Q stage ≥2的患者。研究結果發現,在術後12個月的疾病相關生活品質方面,不論是RCT還是世代研究LSC和VSF組別皆無顯著差異(RCT: P=0.887; cohort: P=0.704)。而針對陰道頂部脫垂 (apical compartment prolapse)的綜合成功率,在RCT和世代研究,LSC組分別為89.3% 及 90.3%,VSF組為86.2% 及87.8%,皆無顯著差異。至於再手術率及併發症在兩組也無顯著差異(再手術 RCT: P=0.934; cohort: P=0.120; 併發症 RCT: P=0.395; cohort: P=0.129)。根據本研究結果,可歸結LSC和VSF在術後12個月的追蹤中,皆為有效的治療。不過文中也提到,雖然無研究上顯著差異,但本研究中只有VSF術後的病患因陰道頂部脫垂需再進行LSC手術,可能可列為臨床醫師選擇手術還有跟病患討論未來再手術率的一個討論要項。

abstract

Objective: To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP-Q stage ≥2 vaginal vault prolapse (VVP).

Design: Multicentre randomised controlled trial (RCT) and prospective cohort study alongside.

Setting: Seven non-university teaching hospitals and two university hospitals in the Netherlands.

Population: Patients with symptomatic post-hysterectomy vaginal vault prolapse, requiring surgical treatment.

Methods: Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP-Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively. Main outcome measures: Primary outcome was disease-specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri-operative data, complications and sexual function.

Results: A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease-specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P = 0.887; cohort: P = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P = 0.810; cohort: P = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P = 0.934; cohort: P = 0.120; complications RCT: P = 0.395; cohort: P = 0.129).

Conclusions: LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow-up period of 12 months.

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