Ñíguez-Sevilla Isabel, Sánchez-Ferrer María Luisa, Ruiz-Cotorruelo Vicente Luis, Wilczak Maciej, Chmaj-Wierzchowska Karolina, Solano-Calvo Juan Antonio, Pérez-Muñuzuri María Elena, Salinas-Peña Juan Raúl, Arense-Gonzalo Julián Jesús
Department of Obstetrics & Gynaecology, "Virgen de la Arrixaca" University Clinical Hospital, 30120 Murcia, Spain.
Biomedical Research Institute of Murcia (IMIB-Arrixaca), University Clinical Hospital "Virgen de la Arrixaca", 30120 Murcia, Spain.
J Clin Med. 2025 Mar 18;14(6):2069. doi: 10.3390/jcm14062069.
Laparoscopic sacropexy (SCL) is the gold standard technique for the correction of apical pelvic organ prolapse (POP). However, other easier laparoscopic techniques, such as laparoscopic lateral suspension (LLS), have become popular. We conducted a multicenter randomized study of patients undergoing laparoscopic repair of apical and anterior prolapse. Patients were randomized into two groups: LLS vs. SCL. A non-inferiority study was proposed, in which the null hypothesis was that the difference in the proportion of therapeutic failures among women who undergo LLS compared to SCL is ≥15%. It was necessary to include 182 participants to detect a risk difference of 15% after one year with a statistical power of 0.80. We recruited 176 women, of whom 106 patients underwent surgery with a follow-up between 1 and 12 months. There were no differences in basal characteristics. Regarding physical examination, there were no differences at stages III-IV in the POP-Q or the symptom scales in both groups. Concerning the post-surgical results, there were no failures detected in the physical examination in any group. There were no differences in the points of the POP-Q, the symptom scales, or the body image scale. We only found significant differences in the operative time, which was shorter for the LLS. Although these are preliminary results, since the sample includes 106 patients and the follow-up time is a limited period at the moment, we did not find any post-surgical differences between the two techniques. However, it will be necessary to complete the trial to draw relevant conclusions.
腹腔镜骶骨固定术（SCL）是治疗盆腔脏器顶端脱垂（POP）的金标准技术。然而，其他更简便的腹腔镜技术，如腹腔镜侧方悬吊术（LLS），也已流行起来。我们对接受腹腔镜修复顶端和前部脱垂的患者进行了一项多中心随机研究。患者被随机分为两组：LLS组和SCL组。我们进行了一项非劣效性研究，其原假设是接受LLS治疗的女性与接受SCL治疗的女性相比，治疗失败比例的差异≥15%。为了在一年后检测出15%的风险差异且统计效能为0.80，有必要纳入182名参与者。我们招募了176名女性，其中106例患者接受了手术，随访时间为1至12个月。两组患者的基线特征无差异。在体格检查方面，两组在POP-Q分期III-IV期以及症状量表方面均无差异。关于手术结果，两组在体格检查中均未发现失败病例。两组在POP-Q评分、症状量表或身体形象量表方面均无差异。我们仅发现手术时间存在显著差异，LLS组的手术时间更短。尽管这些是初步结果，由于样本包含106例患者且目前随访时间有限，但我们未发现两种技术在术后存在任何差异。然而，有必要完成该试验以得出相关结论。
