Page Ann-Sophie, Cattani Laura, Pacquée Stefaan, Claerhout Filip, Callewaert Geertje, Housmans Susanne, Van der Aa Frank, D'Hoore André, Deprest Jan
Department Obstetrics & Gynecology and the Department Urology, Pelvic Floor Unit, and the Department Abdominal Surgery, University Hospitals KU Leuven, Academic Department Development and Regeneration, Cluster Urogenital Surgery, and Academic Department Oncology, KU Leuven, Leuven, the Department Obstetrics & Gynecology, General Hospital Saint-Lucas, Bruges, and the Department Obstetrics & Gynecology, General Hospital Diest, Diest, Belgium; and the Department of Obstetrics & Gynecology, Sydney Medical School Nepean, University of Sydney, Kingswood, New South Wales, Australia.
Obstet Gynecol. 2023 Jan 1;141(1):189-198. doi: 10.1097/AOG.0000000000005021. Epub 2022 Nov 30.
To estimate the long-term incidence and characteristics of graft-related complications, rate of reintervention for graft-related complications and prolapse, and subjective and anatomical outcomes after laparoscopic sacrocolpopexy with heavier-weight (more than 44 g/m2) compared with lightweight (28 g/m2) polypropylene mesh, the latter with resorbable poliglecaprone component.
We conducted a single-center study that compared two consecutive prospective cohorts of patients who were undergoing laparoscopic sacrocolpopexy for symptomatic stage 2 or greater cervical or vault prolapse, by using either heavier-weight polypropylene mesh or lightweight polypropylene mesh at a similar duration of follow-up. The primary outcome was the occurrence of graft-related complications and their nature. Secondary outcomes included reinterventions for graft-related complications, recurrent apical prolapse, a subjective outcome (PGIC [Patient Global Impression of Change] score 4 or higher), and an anatomical outcome (point C -1 cm or greater).
We identified consecutive patients: 101 were implanted with heavier-weight polypropylene, and 238 were implanted with lightweight polypropylene; all were audited at comparable follow-up times (heavier-weight mesh: 97 months [interquartile range 16 months]; lightweight mesh: 92.5 months [interquartile range 58 months]). Graft-related complications were more frequent in patients with heavier-weight than lightweight mesh (22.8% [23/101] vs 7.3% [13/178]; hazard ratio [HR] 3.3, 95% CI 1.6-7.1), more frequently symptomatic (heavier-weight mesh: 16.8% [17/101] vs lightweight mesh: 2.8% [5/178]; HR 6.0, 95% CI 2.5-14.3), and more frequently lead to reintervention for graft-related complications (heavier-weight mesh: 18.8% [19/101] vs lightweight mesh: 2.1% [5/238]; HR 4.6, 95% CI 1.9-11.2). The vast majority of patients improved (PGIC score 4 or higher), without difference between groups (heavier-weight mesh: 71/84 [84.9%]; lightweight mesh: 154/178 [86.5%]; HR 0.8, 95% CI 0.6-1.1); neither was there a difference in anatomical failure rate (heavier-weight mesh: 1/60 [1.7%] vs lightweight mesh: 8/131 [6.1%]; HR 0.3, 95% CI 0.1-1.4). Reoperations for recurrent vault prolapse were scarce (0.0% in heavier-weight mesh, vs 0.4% in lightweight mesh).
In two consecutive cohorts, the number of graft-related complications, symptomatic graft-related complications, and reinterventions for graft-related complications were higher in patients implanted with heavier-weight polypropylene than when lightweight polypropylene was used. There were no differences in subjective, objective outcomes, and reoperation rates for prolapse.
ClinicalTrials.gov, NCT04378400.
To assist in this audit, the University Hospitals Leuven received support from Ethicon Endosurgery.
评估与移植物相关并发症的长期发生率及特征、因移植物相关并发症和脱垂而再次干预的发生率，以及与使用重量更重（超过44 g/m2）聚丙烯网片的腹腔镜骶骨阴道固定术相比，使用重量较轻（28 g/m2）且含可吸收聚乙醇酸成分的聚丙烯网片进行腹腔镜骶骨阴道固定术后的主观和解剖学结局。
我们进行了一项单中心研究，比较了两个连续的前瞻性队列，这些队列中的患者因有症状的2期或更严重的宫颈或穹窿脱垂而接受腹腔镜骶骨阴道固定术，在相似的随访期内分别使用重量更重的聚丙烯网片或重量较轻的聚丙烯网片。主要结局是与移植物相关并发症的发生及其性质。次要结局包括因移植物相关并发症进行的再次干预、复发性顶端脱垂、主观结局（患者整体改善印象[PGIC]评分为4或更高）和解剖学结局（C点下降1 cm或更多）。
我们纳入了连续的患者：101例植入了重量更重的聚丙烯网片，238例植入了重量较轻的聚丙烯网片；所有患者均在可比的随访时间进行了审核（重量更重的网片：97个月[四分位间距16个月]；重量较轻的网片：92.5个月[四分位间距58个月]）。与移植物相关并发症在使用重量更重网片的患者中比使用重量较轻网片的患者更常见（22.8%[23/101]对7.3%[13/178]；风险比[HR]3.3，95%置信区间1.6 - 7.1），更常出现症状（重量更重的网片：16.8%[17/101]对重量较轻的网片：2.8%[5/178]；HR 6.0，95%置信区间2.5 - 14.3），并且更常导致因移植物相关并发症而进行再次干预（重量更重的网片：18.8%[19/101]对重量较轻的网片：2.1%[5/238]；HR 4.6，95%置信区间1.9 - 11.2）。绝大多数患者病情改善（PGIC评分为4或更高），两组之间无差异（重量更重的网片：71/84[84.9%]；重量较轻的网片：154/178[86.5%]；HR 0.8，95%置信区间0.6 - 1.1）；解剖学失败率也无差异（重量更重的网片：1/60[1.7%]对重量较轻的网片：8/131[6.1%]；HR 0.3，95%置信区间0.1 - 1.4）。因复发性穹窿脱垂进行的再次手术很少（重量更重的网片中为0.0%，重量较轻的网片中为0.4%）。
在两个连续队列中，与使用重量较轻的聚丙烯网片相比，植入重量更重的聚丙烯网片的患者中与移植物相关并发症、有症状的与移植物相关并发症以及因移植物相关并发症进行再次干预的数量更多。在主观、客观结局以及脱垂再次手术率方面没有差异。
ClinicalTrials.gov，NCT04378400。
为协助此次审核，鲁汶大学医院获得了爱惜康内镜外科公司的支持。
