Wong Vivien, Shek Ka Lai, Korda Andrew, Benness Chris, Pardey John, Dietz Hans Peter
Nepean Clinical School, University of Sydney, Penrith, Australia.
Nepean Hospital, University of Sydney, Penrith, New South Wales, Australia.
Int Urogynecol J. 2019 Dec;30(12):2127-2133. doi: 10.1007/s00192-019-04062-0. Epub 2019 Aug 6.
Female pelvic organ prolapse recurrence has been shown to be associated with levator hiatal distensibility. Reducing hiatal size surgically may reduce recurrence risk. This study aims to demonstrate a novel surgical procedure, the puborectalis sling (PR sling), designed to reduce the levator hiatal area, and to assess the medium-term safety and efficacy of this procedure.
One hundred fifteen women undergoing prolapse repair with a pre-operative hiatal area on Valsalva of ≥ 35 cm were recruited into this phase 1 prospective multicentre pilot study. All underwent a PR sling procedure after completion of standard repairs. Primary outcome was levator hiatal area measured on ultrasound.
One hundred ten patients were evaluated at least 3 months post-operatively. At 2.5 years average follow-up, there was an average of 12 cm (range 6-16 cm) reduction in hiatal area from a mean pre-operative hiatal area of 43.9 (35-63) cm. Thirty per cent (28/93) were symptomatic of prolapse, 66% (61/93) had clinical prolapse recurrence whilst 49% (46/93) had sonographic recurrence. Three patients required a return to theatre; one case of infection resulted in mesh removal, one had severe obstructed defecation requiring sling loosening and another had buttock pain with faecal impaction that resolved after manual disimpaction. There were no long-term sequelae.
The levator hiatal area can be reduced surgically, with almost 30% reduction in area seen in this pilot study. The reduction was significant and sustained up to 2 years with no major long-term complications.
女性盆腔器官脱垂复发已被证明与肛提肌裂孔扩张性有关。通过手术减小裂孔大小可能会降低复发风险。本研究旨在展示一种新型手术方法，即耻骨直肠肌吊带术（PR吊带术），该方法旨在减小肛提肌裂孔面积，并评估该手术方法的中期安全性和有效性。
115名在Valsalva动作时术前裂孔面积≥35平方厘米的接受脱垂修复手术的女性被纳入这项1期前瞻性多中心试点研究。所有患者在完成标准修复后均接受PR吊带术。主要结局指标是通过超声测量的肛提肌裂孔面积。
110名患者在术后至少3个月接受了评估。在平均2.5年的随访中，裂孔面积从术前平均43.9（35 - 63）平方厘米平均减少了12平方厘米（范围为6 - 16平方厘米）。30%（28/93）有脱垂症状，66%（61/93）有临床脱垂复发，而49%（46/93）有超声检查复发。3名患者需要再次手术；1例感染导致补片取出，1例严重排便梗阻需要松解吊带，另1例有臀部疼痛伴粪便嵌塞，经人工排便后缓解。无长期后遗症。
肛提肌裂孔面积可通过手术减小，在本试点研究中面积减少了近30%。这种减少是显著的，并且持续长达2年，无重大长期并发症。
