Morciano Andrea, Caliandro Dario, Campagna Giuseppe, Panico Giovanni, Giaquinto Alessia, Fachechi Giorgio, Zullo Marzio Angelo, Tinelli Andrea, Ercoli Alfredo, Scambia Giovanni, Cervigni Mauro, Marzo Giuseppe
Panico Pelvic Floor Center, Department of Gynaecology and Obstetrics, Pia Fondazione "Card. G. Panico", Tricase, Lecce, Italy.
AIUG Research GroupAssociazione Italiana di UroGinecologia e del Pavimento Pelvico, Rome, Italy.
Arch Gynecol Obstet. 2022 Nov;306(5):1573-1579. doi: 10.1007/s00404-022-06682-2. Epub 2022 Jul 15.
Laparoscopic ventral rectopexy (LVR) plus sacral colpopexy (LSC) is a high-complexity surgical procedure. The aim of the present study was to evaluate a new approach to rectal-mesh fixation during LVR with continuous locked suture.
This is a prospective randomized double-blinded clinical trial enrolling 80 patients with severe POP and obstructed defecation syndrome (ODS) from November 2016 to January 2021. Patients underwent a "two-meshes" LSC plus LVR and were randomized, regarding rectal mesh fixation, in Group A (extracorporeal interrupted 0 delayed absorbable sutures) and Group B ("U-shaped" running locked 0 delayed absorbable suture). Our primary endpoints were the operative times (OT); the secondary endpoints were the incidence of anatomical failures, vaginal mesh erosions and surgical complications.
A total of 75 patients completed the study. Baseline characteristics were similar between the groups. Overall OT (156 vs 138 min; p < 0.05; treatment reduction of 11.5%) and LVR mesh fixation time (29 vs 16 min; p < 0.05; treatment reduction of 44%), resulted in significantly lower in Group B. No differences were found in terms of anatomic failure, vaginal mesh erosion or intra- or post-operative complications. PGI-I, FSDS and Wexner questionnaires resulted significantly improved after surgery, without statistical differences between the studied surgical procedures.
Laparoscopic continuous locked 0 absorbable suture for LVR mesh fixation guaranteed a faster and effective alternative to multiple interrupted sutures. The significant OT reduction linked to this technique should be considered even more helpful when performing a highly complex surgery such as LVR.
NCT05254860 (13/02/2017).
腹腔镜腹直肌固定术（LVR）联合骶骨阴道固定术（LSC）是一种高复杂性的外科手术。本研究的目的是评估一种在LVR期间使用连续锁定缝合进行直肠网片固定的新方法。
这是一项前瞻性随机双盲临床试验，从2016年11月至2021年1月招募了80例患有严重盆腔器官脱垂（POP）和排便障碍综合征（ODS）的患者。患者接受了“双网片”LSC加LVR手术，并在直肠网片固定方面随机分为A组（体外间断0号延迟可吸收缝线）和B组（“U形”连续锁定0号延迟可吸收缝线）。我们的主要终点是手术时间（OT）；次要终点是解剖学失败、阴道网片侵蚀和手术并发症的发生率。
共有75例患者完成了研究。两组之间的基线特征相似。总体OT（156分钟对138分钟；p＜0.05；治疗时间减少11.5%）和LVR网片固定时间（29分钟对16分钟；p＜0.05；治疗时间减少44%），B组明显更低。在解剖学失败、阴道网片侵蚀或手术中或术后并发症方面未发现差异。PGI-I、FSDS和Wexner问卷结果显示手术后有显著改善，所研究的手术方法之间无统计学差异。
用于LVR网片固定的腹腔镜连续锁定0号可吸收缝线保证了一种比多次间断缝合更快且有效的替代方法。当进行诸如LVR这样的高复杂性手术时，与该技术相关的显著OT减少应被认为更有帮助。
NCT05254860（2017年2月13日）。
