Russo Eleonora, Montt Guevara Maria Magdalena, Sacinti Koray Gorkem, Misasi Giulia, Falcone Maria, Morganti Riccardo, Mereu Liliana, Dalprà Francesca, Tateo Saverio, Simoncini Tommaso
Division of Obstetrics and Gynecology, Department of Experimental and Clinical Medicine, University of Pisa, 56126 Pisa, Italy.
Department of Obstetrics and Gynecology, Ankara University School of Medicine, 06100 Ankara, Turkey.
J Clin Med. 2023 Apr 18;12(8):2926. doi: 10.3390/jcm12082926.
Abdominal minimally invasive surgery has become increasingly prominent for the treatment of prolapse. Abdominal sacral colpopexy (ASC) is the gold standard for the treatment of advanced apical prolapse; however, alternative surgical approaches such as the abdominal lateral suspension (ALS) have been developed to improve patient outcomes. This study aims to determine whether ALS improves outcomes compared to ASC in multicompartmental prolapse patients.
A prospective, open-label, multicenter, non-inferiority trial was conducted in 360 patients who underwent ASC or ALS for the treatment of apical prolapse. The primary outcome was anatomical and symptomatic cure of the apical compartment at 1-year follow-up; secondary outcomes included prolapse recurrence, re-operation rate, and post-operative complications. A 300-patient cohort was subdivided into 200-patients who underwent ALS and 100-patients who underwent ASC. The confidence interval method was used to calculate the -value of non-inferiority.
At the 12-months follow-up, the objective cure rate of the apical defect was 92% for ALS and 94% for ASC (recurrence rates were 8% and 6%, respectively, and the -value for non-inferiority was <0.01). The mMesh complication rates were 1% and 2% for ALS and ASC, respectively.
This study demonstrated that the ALS technique is not inferior to the gold standard ASC for the surgical treatment of apical prolapse.
腹部微创手术在治疗脏器脱垂方面日益突出。腹骶阴道固定术（ASC）是治疗重度顶端脱垂的金标准；然而，已开发出如腹部侧方悬吊术（ALS）等替代手术方法以改善患者预后。本研究旨在确定在多部位脱垂患者中，与ASC相比，ALS是否能改善预后。
对360例接受ASC或ALS治疗顶端脱垂的患者进行了一项前瞻性、开放标签、多中心、非劣效性试验。主要结局是随访1年时顶端部位的解剖学治愈和症状缓解；次要结局包括脱垂复发、再次手术率和术后并发症。将300例患者的队列分为200例行ALS的患者和100例行ASC的患者。采用置信区间法计算非劣效性的P值。
在12个月的随访中，ALS组顶端缺损的客观治愈率为92%，ASC组为94%（复发率分别为8%和6%，非劣效性P值<0.01）。ALS组和ASC组的网片相关并发症发生率分别为1%和2%。
本研究表明，在顶端脱垂的手术治疗中，ALS技术不劣于金标准ASC。
