Goh Yi Man, Lim Shu Hui, Chua Hong Liang, Han How Chuan, Lee Jill C
Department of Urogynaecology, KK Women's and Children's Hospital, Singapore, SGP.
Department of Obstetrics and Gynaecology, KK Women's and Children's Hospital, Singapore, SGP.
Cureus. 2024 Jun 30;16(6):e63513. doi: 10.7759/cureus.63513. eCollection 2024 Jun.
Objective The objective of this study was to evaluate the efficacy and long-term outcomes of the use of Restorelle® Direct Fix (Coloplast, Humlebæk, Denmark) anterior mesh for transvaginal surgical management of anterior compartment prolapse. Methods A retrospective case series review was conducted for 123 patients who underwent surgery for Baden-Walker Grade three and four anterior compartment prolapse with the Restorelle Direct Fix anterior mesh between July 1, 2017 and September 30, 2018 in a single center. Follow-up was conducted at one, six, 12, 24, and 36 months after treatment. A standardized questionnaire and pelvic examination were conducted at each visit to assess operative complications and subjective and objective cure rates. Results Sixty patients were included in the analysis with a three-year follow-up rate of 70.0%. At three years post-operatively, subjective and objective cure rates were 97.7% and 95.3% respectively. Seven (11.7%) patients complained of de novo stress urinary incontinence, four (6.7%) complained of de novo urge urinary incontinence and one (1.7%) complained of symptomatic recurrence. Significantly, six (10.0%) patients had transvaginal mesh exposure over the three-year follow-up, mostly presenting within the first year. One (2.4%) patient developed new asymptomatic mesh erosion at the 36-month visit and one patient required mesh loosening one month post-surgery. Conclusions Management of anterior compartment prolapse with transvaginal surgery using the Restorelle® Direct Fix anterior mesh was associated with good subjective and objective cure rates. However, significant rates of post-operative mesh exposure were noted within three years post-surgery, which hinders the recommendation of this device for augmentation of repair for anterior compartment prolapse.
目的 本研究的目的是评估使用Restorelle® Direct Fix（康乐保公司，丹麦胡姆勒拜克）前路补片经阴道手术治疗前盆腔脏器脱垂的疗效和长期预后。方法 对2017年7月1日至2018年9月30日在单中心接受手术治疗Baden-Walker Ⅲ度和Ⅳ度前盆腔脏器脱垂并使用Restorelle Direct Fix前路补片的123例患者进行回顾性病例系列研究。治疗后1、6、12、24和36个月进行随访。每次随访时进行标准化问卷调查和盆腔检查，以评估手术并发症以及主观和客观治愈率。结果 60例患者纳入分析，三年随访率为70.0%。术后三年，主观和客观治愈率分别为97.7%和95.3%。7例（11.7%）患者出现新发压力性尿失禁，4例（6.7%）出现新发急迫性尿失禁，1例（1.7%）出现症状复发。值得注意的是，6例（10.0%）患者在三年随访期间出现经阴道补片暴露，大多在第一年内出现。1例（2.4%）患者在36个月随访时出现新的无症状补片侵蚀，1例患者术后1个月需要补片松解。结论 使用Restorelle® Direct Fix前路补片经阴道手术治疗前盆腔脏器脱垂的主观和客观治愈率良好。然而，术后三年内补片暴露率较高，这妨碍了推荐使用该装置加强前盆腔脏器脱垂修补术。
