Center for Urogynecology & Reconstructive Surgery, Subspecialty Care for Women's Health, Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA.
, Cleveland, USA.
Int Urogynecol J. 2021 Jun;32(6):1565-1570. doi: 10.1007/s00192-020-04657-y. Epub 2021 Jan 20.
To compare prolapse recurrence and the incidence of mesh exposure between Restorelle® Y mesh and dual flat mesh.
A randomized trial of women undergoing laparoscopic (LSC) or robotic (RSC) sacrocolpopexy for post-hysterectomy vaginal prolapse. Subjects were randomized to either Y mesh or dual flat mesh. Subjects underwent a pelvic examination with POP-Q and evaluation of any mesh exposure, and the PFDI-20 was administered at 6, 12 and 24 months postoperatively. Subjective recurrence was defined by symptomatic vaginal bulge. All subjects underwent pelvic examination with POP-Q at 6, 12 and 24 months. Objective recurrence was defined by descent of the apex > 1/3 into the vaginal canal, anterior or posterior vaginal descent beyond the hymen, or retreatment for prolapse.
Sixty-two patients were enrolled, and 59 patients were implanted with mesh: 30 Y mesh (17 LSC, 13 RSC) and 29 flat mesh (18 LSC, 11 RSC). There were no differences in patient characteristics between the groups. At 24 months, data were available for 44 (74.5%) patients. There were no mesh exposures for all subjects. PFDI-20 scores improved significantly for all subjects with no differences in mean improvement by mesh configuration. There were no differences in subjective and objective recurrence rates between the groups. Four patients (9.1%) complained of subjective vaginal bulge symptoms while nine (20.5%) patients had an objective recurrence (77.8% [7] examination only and 22.2% [2] reoperation). There were no apical recurrences. Of those patients who had a recurrence on examination only (n = 7), 85.7% (6) were asymptomatic.
At 24 months, there were no differences in subjective outcomes and prolapse recurrence in patients who underwent sacrocolpopexy with the Restorelle® Y mesh versus dual flat mesh. One in five patients experienced an objective recurrence; however, there were no apical recurrences and the majority were asymptomatic.
比较 Restorelle®Y 网片与双平面网片在脱垂复发和网片暴露方面的差异。
这是一项针对因子宫切除术后阴道脱垂而行腹腔镜（LSC）或机器人辅助腹腔镜（RSC）骶骨阴道固定术的女性患者的随机试验。受试者被随机分为 Y 网片组或双平面网片组。受试者均接受盆腔检查，包括 POP-Q 评估和任何网片暴露情况的评估，并在术后 6、12 和 24 个月时进行 PFDI-20 问卷调查。症状性阴道膨出定义为主观复发。所有受试者均在术后 6、12 和 24 个月时接受盆腔检查和 POP-Q 评估。顶点下降超过阴道 1/3、前或后阴道下降超过处女膜或因脱垂再次治疗定义为客观复发。
共纳入 62 例患者，59 例患者植入了网片：30 例 Y 网片（17 例 LSC，13 例 RSC）和 29 例双平面网片（18 例 LSC，11 例 RSC）。两组患者的特征无差异。24 个月时，44 例（74.5%）患者可获得数据。所有患者均无网片暴露。所有患者的 PFDI-20 评分均显著改善，网片类型对平均改善程度无影响。两组患者的主观和客观复发率无差异。4 例（9.1%）患者诉主观阴道膨出症状，9 例（20.5%）患者出现客观复发（77.8%[7]仅检查，22.2%[2]再次手术）。无顶点复发。在仅检查发现复发的 7 例患者中（n=7），85.7%（6 例）无症状。
在 24 个月时，与双平面网片相比，Restorelle®Y 网片用于骶骨阴道固定术的患者在主观结局和脱垂复发方面无差异。五分之一的患者出现客观复发；然而，无顶点复发，且大多数患者无症状。
