經陰道網線手術治療骨盆器官脫垂與一年良好預後有關


  December 26, 2008 — 根據一項發表於2009年1月1日婦科與產科期刊的前瞻性、多中心世代研究結果顯示,套針指引的經陰道網線手術,對於治療骨盆腔器官脫垂的效果,在一年時有良好預後。
  
  來自瑞典斯德哥爾摩Karolinska Institutet Danderyd醫院的Caroline Elm?r醫師與其北歐經陰道網線手術團隊的同事們寫到,因為缺乏臨床安全性與療效數據,採用聚丙烯作為骨盆腔器官脫垂手術仍是個懸而未決的問題。曾經有人提到為了讓生物材料提供預期的骨盆腔支持,他們必須固定在受影響的組織外面,這使得使用經閉孔或經臀肌方式的套管導引經陰道手術技術,從骨盆筋膜韌帶弓或是薦脊韌帶通過網線固定手臂。
  
  這項研究在26個診所進行,目的是評估在使用聚丙烯網線的標準化套管導引外科裝置術後預後。脫垂以試驗前、術後兩個月、一年時的骨盆腔器官脫垂計量系統(POP-Q)、尿失禁影響問卷(IIQ-7)以及泌尿道疾患紀錄(UDI-6)評估;解剖癒合以術後POP-Q分級0~1定義。
  
  收納到這項研究的261位病患有232位(89%)完成一年後續追蹤,病患手術時的平均年齡為66.3 ± 9.4歲,121位接受前端網線修復的女性中,有96位(79%)達到術後一年的解剖癒合(P <0.001),而接受後端網線修復的女性中,68位有56位(82%)達到術後一年的解剖癒合(P<0.001),而63位接受前分隔中的51位(81%)以及63位接受後分隔中的54位(86%)都有同樣的結果(兩者的P都<0.001)。
  
  252位中有9位(3.4%)發生膀胱與直腸穿孔,而232位中有26位(11%)發生陰道糜爛,其中大部分是輕微到中度的。因為網線外露,7位女性(2.8%)需要手術介入。
  
  IIQ-7的所有區塊都顯示有顯著的生活品質改進。雖然UDI-6分數改善顯著,但是壓力性尿失禁的症狀特定疾患並未減少。
  
  研究作者們寫到,套管導引的經陰道網線手術,應用在骨盆腔器官脫垂與術後一年良好的主觀和客觀預後有關。
  
  這項研究的限制包括因為沒有對所有研究中心的術後POP-Q檢驗以獨立的檢驗者評估,所可能帶來某個程度上的分類誤差,較寬的收納標準潛在地引入了某些選擇性誤差,以及缺乏獨立的控制組。
  
  作者的結論是,這項創新的術式,以及狀況特定的預後評估,多中心研究設計,以及前瞻性地資料收集都是這項研究方法學上的優點。現在需要隨機分派研究來釐清,相較於傳統脫垂修復手術,使用這個合成網線工具在脫垂手術中的風險與好處,以及病患滿意度。
  
  瑞典醫學會與斯德哥爾摩郡議會及Karolinska機構的醫學訓練與臨床研究區域協議贊助這項研究。Gynecare Scandinavia公司贊助與這項研究有關的研究者會議,並僱用其中兩位作者為該公司顧問。

Transvaginal Mesh Surgery for Pelvic Organ Prolapse Linked to Good 1-Year Outcomes

By Laurie Barclay, MD
Medscape Medical News

December 26, 2008 — Trocar-guided transvaginal mesh surgery for pelvic organ prolapse results in good clinical outcomes at 1 year, according to the results of a prospective, multicenter cohort study reported in the January 1, 2009, issue of Obstetrics and Gynecology.

"Due to the lack of clinical safety and efficacy data, the adoption of polypropylene mesh for pelvic organ prolapse surgery remains a source of controversy," write Caroline Elmer, MD, from the Karolinska Institutet Danderyd Hospital in Stockholm, Sweden, and colleagues from the Nordic Transvaginal Mesh Group. "It has been suggested that in order for biomaterials to provide the intended pelvic floor support, they need to be 'anchored' outside the afflicted tissues. This has given rise to trocar-guided transvaginal surgical techniques using a transobturator or transgluteal approach, passing the mesh fixation arms through the arcus tendineus fascia pelvis or the sacrospinous ligaments."

The goal of this study, which was conducted in 26 clinics, was to evaluate clinical outcomes after pelvic organ prolapse repair with a standardized trocar-guided surgical device using polypropylene mesh. Prolapse was graded with use of the pelvic organ prolapse quantification system (POP-Q), and symptoms were evaluated with use of the Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6) at baseline, 2 months, and 1 year after surgery. Anatomic cure was defined as postoperative POP-Q stage 0 to 1.

Of 261 patients included in the study, 232 (89%) attended the 1-year follow-up. Mean age at surgery was 66.3 ± 9.4 years. Anatomic cure 1 year after surgery occurred in 96 (79%) of 121 women after anterior repair with mesh (P < .001), and in 56 (82%) of 68 women after posterior repair with mesh (P <.001). In women undergoing combined anterior and posterior mesh repair, cure occurred in 51 (81%) of 63 for the anterior compartment and 54 (86%) of 63 for the posterior compartment (P < .001 for both).

Nine (3.4%) of 252 patients had bladder and rectal perforations, and 26 (11%) of 232 patients developed vaginal erosions, most of which were mild to moderate. Seven women (2.8%) required surgical intervention because of mesh exposure.

All domains of the IIQ-7 showed significant quality-of-life improvements. Although UDI-6 scores improved significantly, symptoms specific for stress urinary incontinence were not reduced.

"Trocar-guided transvaginal mesh surgery for pelvic organ prolapse is associated with satisfactory objective and subjective outcomes 1 year after surgery," the study authors write.

Limitations of this study include some degree of classification bias caused by not having access to an independent examiner for the postoperative POP-Q examinations at all study sites, wide inclusion criteria potentially introducing some selection bias, and lack of an independent control group.

"The uniform surgical technique, the condition-specific outcome measures, the multicenter setting, and the prospective data collection are some of the methodologic merits of our study," the study authors conclude. "Randomized controlled trials are now needed to clarify how the risks and benefits associated with the use of synthetic mesh kits in prolapse surgery relate to patient satisfaction when compared with traditional prolapse repair."

The Swedish Society of Medicine and the regional agreement on medical training and clinical research between Stockholm county council and Karolinska Institutet supported this study. Gynecare Scandinavia sponsored investigator meetings related to the study and used 2 of the study authors as advisors.

Obstet Gynecol. 2009;113:117-126.

    
相關報導
生產時的肌肉損傷與骨盆器官脫垂有關
2007/2/12 下午 04:02:00

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