Sacrospinous ligament fixation

骶棘韧带固定术
  • 文章类型: Journal Article
    目的:骶棘韧带固定术(SSLF)是治疗根尖脱垂的一种常用外科技术。缝线捕获装置(SCD)的使用,或者最近推出的基于锚的设备(ABD),对于后路是有用的,但对于前路是必不可少的。我们研究的目的是评估ABD的安全性,最近被介绍给我们单位,与传统使用的SCD相比。
    方法:这是一项针对40例SSLF患者的试点病例对照研究,其中20个代表在ABD的帮助下进行手术的所有患者和在大约相同的持续时间内使用SCD进行手术的20个患者。这项初步研究的主要安全性终点是患者报告的术后疼痛评分和围手术期并发症发生率。
    结果:人群特征相似。平均术后疼痛评分仅在术后第1天显着差异,有利于缝合捕获装置(3.40[2.60]vs1.60[1.64],p=0.013)。两组的平均最高疼痛评分相似。围手术期并发症发生率较低,两组之间具有可比性。根据POPQ,在6周随访时,ABD组的中位数Ba点更高,并且这种差异是显着的(-3.00[-3.00;-2.25]vs.-2.00[-3.00;-1.50];p=0.03)。
    结论:基于锚钉的骶脊髓韧带固定装置似乎具有与传统使用的缝线捕获装置相当的安全性。
    OBJECTIVE: Sacrospinous ligament fixation (SSLF) is a popular surgical technique for treating apical prolapse. The use of suture-capturing devices (SCD), or the more recently introduced anchor-based device (ABD), is useful for a posterior approach but essential for an anterior one. The aim of our study was to assess the safety of the ABD, which was recently introduced to our unit, compared to the traditionally used SCD.
    METHODS: This was a pilot case-control study of 40 patients who had a SSLF, 20 of these represented all the patients who had the procedure with the aid of the ABD and 20 patients who had the procedure using the SCD over approximately the same duration. The main safety endpoints of this pilot study were patient reported postoperative pain scores and perioperative complications rate.
    RESULTS: The population characteristics were similar. The mean postoperative pain scores differed significantly only on postoperative day 1 in favor of the suture capturing device (3.40 [2.60] vs 1.60 [1.64], p = 0.013). The mean highest pain score was similar in both groups. Peri-operative complications rates were low and comparable between both groups. According to POPQ at 6 weeks follow-up the median Ba point was higher in the ABD group and this difference was significant (-3.00 [-3.00; -2.25] vs. -2.00 [-3.00; -1.50]; p = 0.03).
    CONCLUSIONS: The anchor-based device for sacrospinal ligament fixation seems to have comparable safety profile to the traditionally used suture capturing devices.
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  • 文章类型: Journal Article
    目的:比较骶棘韧带固定术(SSLF)用于通过PVDF网片(腹腔镜胸膜固定术,LP)在治愈率和术后并发症发生率方面。
    方法:这项前瞻性研究包括160例根据POP-Q系统诊断为盆腔器官脱垂II-IV期的患者。82例(51.25%)接受了阴道骶棘韧带固定术,78例(48.75%)接受了腹腔镜胸膜固定术。
    结果:两组治愈率均较高,SSLF组95.12%的患者(82个中的78个)和LP组93.59%的患者(78个中的73个)术后治愈,导致160名患者中151名的整体治愈率。所有患者中有5.00%出现盆腔疼痛,但SSLF组(7,8.54%)明显高于LP组(1,1.28%)。所有患者中有4.37%出现了性交困难,SSLF组(6,7.32%)比LP组(1,1.28%)略高,但没有显著差异。
    结论:腹腔镜胸膜固定术与传统骶棘韧带固定术相比,随访结果相当。SSLF和LP均可有效治疗盆腔器官脱垂,具有良好的解剖学和主观结果,治愈率高,术后严重并发症发生率低。
    OBJECTIVE: To compare the follow-up results of a sacrospinous ligament fixation (SSLF) technique for laparoscopic bilateral fixation of the vagina to the iliopectineal ligament via a PVDF-mesh (laparoscopic pectopexy technique, LP) in terms of cure rate and postoperative complications rate.
    METHODS: This prospective study included 160 patients diagnosed with pelvic organ prolapse stage II-IV according to the POP-Q system. Eighty-two patients (51.25%) underwent vaginal sacrospinous ligament fixation and seventy-eight patients (48.75%) underwent the laparoscopic pectopexy procedure.
    RESULTS: The cure rate was high in both groups, 95.12% of the patients (78 out of 82) in the SSLF group and 93.59% of the patients (73 out of 78) in the LP group were cured post surgery, leading to an overall cure rate of 151 out of 160 patients. Pelvic pain was present in 5.00% of all patients, but was notably more frequent in the SSLF group (7, 8.54%) than in the LP group (1, 1.28%). Dyspareunia occurred in 4.37% of all patients, slightly more frequently in the SSLF group (6, 7.32%) than the LP group (1, 1.28%), but without significant difference.
    CONCLUSIONS: The laparoscopic pectopexy procedure has comparably positive follow-up results with the conventional sacrospinous ligament fixation procedure. Both SSLF and LP are effective in the treatment of pelvic organ prolapse, with favorable anatomical and subjective results, a high cure rate and low rates of serious postoperative complications.
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  • 文章类型: Journal Article
    目的:EnPlace®装置是一种新颖的微创工具,可用于经阴道骶棘韧带(SSL)固定骨盆顶端器官脱垂(POP)。该研究旨在调查EnPlace®SSL固定用于显著根尖POP修复的安全性和短期疗效。
    方法:一项回顾性队列研究,对123例III期或IV期心尖POP患者(平均年龄64.4±11.1岁)进行了EnPlace®装置SSL固定。分析并比较了91例(74%)子宫脱垂患者与32例(26%)阴道穹窿脱垂患者的安全性和6个月预后结果。
    结果:没有术中或术后早期并发症。手术的平均时间(±标准偏差)为30±6.9分钟,平均失血量为30.5±18.5mL。术前和术后6个月POP定量测量C点的平均位置为4.5±2.8cm和-3.1±3.3cm,分别。91例术前子宫脱垂,8例(8.8%)患者在术后6个月内出现复发性子宫脱垂。32例术前穹窿脱垂,两名患者(6.3%)复发性穹窿脱垂。
    结论:EnPlace®SSL固定的短期结果结果表明,它是一种安全有效的经阴道微创手术,用于显著的根尖POP修复。
    OBJECTIVE: The EnPlace® device is a novel minimally invasive tool allowing transvaginal sacrospinous ligament (SSL) fixation of apical pelvic organ prolapse (POP). The study aimed to investigate the safety and short-term efficacy of the EnPlace® SSL fixation for significant apical POP repair.
    METHODS: A retrospective cohort study of 123 consecutive patients (mean age 64.4 ± 11.1 years) with stage III or IV apical POP who underwent SSL fixation by the EnPlace® device. Safety and 6-month outcome results were analyzed and compared between 91 (74%) patients with uterine prolapse versus 32 (26%) patients with vaginal vault prolapse.
    RESULTS: There were no intraoperative or early postoperative complications. The mean (± standard deviation) duration of surgery was 30 ± 6.9 min and mean blood loss was 30.5 ± 18.5 mL. The average position of point C by POP-Quantification measurements before surgery and at 6 months postoperatively was 4.5 ± 2.8 cm and -3.1 ± 3.3 cm, respectively. Of 91 patients with preoperative uterine prolapse, eight (8.8%) patients developed a recurrent uterine prolapse within 6 months postoperatively. Of 32 patients with preoperative vault prolapse, two patients (6.3%) had recurrent vault prolapse.
    CONCLUSIONS: Short-term outcome results of EnPlace® SSL fixation suggest that it is a safe and effective minimally invasive transvaginal procedure for significant apical POP repair.
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  • 文章类型: Case Reports
    骶棘韧带固定术(SSLF)是治疗根尖脱垂的微创有效方法。因为术中暴露骶棘韧带很困难,SSLF很难。本文的目的是确定单孔腹膜外腹腔镜SSLF治疗根尖脱垂的安全性和可行性。
    这个单中心,单外科医生病例系列研究包括9例盆腔器官脱垂定量(POP-Q)III或IV型根尖脱垂患者,他们接受了单孔腹腔镜SSLF。此外,2例患者行经闭式无张力阴道穿刺(TVT-O),1例患者行骨盆前网片重建。
    手术时间从75到105(平均,88.9±10.2)min,失血范围从25到100(平均,43.3±22.6)ml。无严重手术并发症,输血,内脏损伤,或报告了这些患者的术后臀痛.经过2-4个月的随访,没有POP复发,臀痛,尿潴留/尿失禁,或观察到其他并发症。
    经阴道单口SSLF是一种安全的,有效,和易于掌握的根尖脱垂操作。
    UNASSIGNED: Sacrospinous ligament fixation (SSLF) is a minimally invasive and effective procedure for the treatment of apical prolapse. Because intraoperative exposure of the sacrospinous ligament is difficult, SSLF is difficult. The aim of our article is to determine the safety and feasibility of single-port extraperitoneal laparoscopic SSLF for apical prolapse.
    UNASSIGNED: This single-center, single-surgeon case series study included 9 patients with pelvic organ prolapse quantification (POP-Q) III or IV apical prolapse who underwent single-port laparoscopic SSLF. Additionally, transobturator tension-free vaginal tap (TVT-O) was performed in 2 patients, and anterior pelvic mesh reconstruction was performed in 1 patient.
    UNASSIGNED: The operative time ranged from 75 to 105 (mean, 88.9 ± 10.2) min, and blood loss ranged from 25 to 100 (mean, 43.3 ± 22.6) ml. No serious operative complications, blood transfusions, visceral injuries, or postoperative gluteal pain were reported for these patients. After 2-4 months of follow-up, no recurrence of POP, gluteal pain, urinary retention/incontinence, or other complications was observed.
    UNASSIGNED: Transvaginal single-port SSLF is a safe, effective, and easy-to-master operation for apical prolapse.
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  • 文章类型: Randomized Controlled Trial
    目标:在晚期脱垂的女性中,随着时间的推移,阴道顶点锚定部位的差异可能会影响手术结局.主要目的是比较子宫骶韧带悬吊术(ULS)与骶棘韧带固定术(SSLF)在晚期(III-IV期)脱垂女性中的5年手术效果。
    方法:对一组晚期脱垂女性进行了一项多中心随机试验,比较了ULS与SSLF及其延长随访,使用可公开访问的去识别数据集。主要结果是失败的时间,定义为(1)根尖下降>1/3进入阴道腔或处女膜外的前/后室中的任何一种,(2)令人烦恼的阴道隆起症状,或(3)再治疗。次要结果包括通过盆腔器官脱垂窘迫量表(POPDI)测量的症状严重程度和不良事件。
    结果:在285名女性中,ULS中的90/147(61.2%)和SSLF中的88/138(63.8%)患有晚期脱垂。除了中位阴道分娩外,两组之间的基线特征没有差异(3.0[2.0,5.0]对3.0[2.0,4.0],p<0.01)。中位失败时间为1.7年ULS和2.0年SSLF(p=0.42)。两组的手术失败均随时间增加而增加,组间无差异;到第5年,估计失败率为67.7%ULS对71.5%SSLF(校正后差异-3.8;95CI[-21.9,14.2])。在单个故障组件中没有发现差异(p>0.05)。POPDI评分在5年内改善,无组间差异(ULS-68.0±61.1与SSLF-69.9±60.3,调整后差异-0.1[-20.0,19.9])。观察到不良事件无差异(p>0.05)。
    结论:在晚期脱垂的女性中,手术失败,症状严重程度,在5年内,ULS和SSLF之间的不良事件没有差异。
    In women with advanced prolapse, differences in vaginal apex anchoring sites may impact surgical outcomes over time. The primary aim was to compare 5-year surgical outcomes of uterosacral ligament suspension (ULS) versus sacrospinous ligament fixation (SSLF) in women with advanced (stage III-IV) prolapse.
    A secondary analysis was conducted in a subset of women with advanced prolapse from a multicenter randomized trial comparing ULS versus SSLF and its extended follow-up, using publicly accessible de-identified datasets. The primary outcome was time to failure, defined as any one of (1) apical descent > 1/3 into the vaginal canal or anterior/posterior compartment beyond the hymen, (2) bothersome vaginal bulge symptoms, or (3) re-treatment. Secondary outcomes include symptom severity measured by the Pelvic Organ Prolapse Distress Inventory (POPDI) and adverse events.
    Of 285 women, 90/147 (61.2%) in ULS and 88/138 (63.8%) in SSLF had advanced prolapse. Baseline characteristics did not differ between groups except for median-vaginal deliveries (3.0 [2.0, 5.0] versus 3.0 [2.0, 4.0], p < 0.01). The median time to failure was 1.7 years ULS versus 2.0 years SSLF (p = 0.42). Surgical failure increased over time in both groups with no intergroup difference; by year 5, the estimated failure rate was 67.7% ULS versus 71.5% SSLF (adjusted difference -3.8; 95%CI [-21.9, 14.2]). No differences were noted in individual failure components (p > 0.05). POPDI scores improved over 5 years without intergroup difference (ULS -68.0 ± 61.1 versus SSLF -69.9 ± 60.3, adjusted difference -0.1 [-20.0, 19.9]). No difference in adverse events were observed (p > 0.05).
    In women with advanced prolapse, surgical failure, symptom severity, and adverse events did not differ between ULS and SSLF over 5 years.
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  • 文章类型: Case Reports
    臀部皮肤阴道瘘是一种罕见但重要的术后并发症,可能在骶棘韧带固定术(SSLF)手术后数年出现。SSLF后皮肤阴道瘘的处理数据有限。
    本病例报告描述了一名77岁的患者,在SSLF治疗20年后出现皮肤臀侧阴道脓肿和瘘管。她成功地通过CT引导下经皮臀位脓肿引流和放置引导皮肤阴道导管进行了治疗。腹腔镜盆壁解剖与评价,经阴道定位和切除受感染的永久性缝线。
    SSLF后慢性瘘管状态的治疗应考虑多学科方法,包括介入放射学,泌尿妇科,和微创妇科手术。
    UNASSIGNED: Cutaneous gluteal vaginal fistula is a rare but significant postoperative complication which may present years after sacrospinous ligament fixation (SSLF) surgery There is limited data on the management of cutaneous vaginal fistula following SSLF.
    UNASSIGNED: This case report describes a 77-year-old who presents twenty years after SSLF with cutaneous gluteal vaginal abscess and fistula. She underwent successful management with CT-guided percutaneous drainage of gluteal abscess and placement of guiding cutaneous vaginal catheter, laparoscopic pelvic wall dissection and evaluation, and transvaginal localization and removal of the infected permanent suture.
    UNASSIGNED: Multi-disciplinary approach should be considered in the treatment of chronic fistula status post SSLF, including interventional radiology, urogynecology, and minimally invasive gynecologic surgery.
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  • 文章类型: Journal Article
    目的:评估术后12个月使用永久性和可吸收缝合材料固定骶棘韧带(SSLF)的成功和安全性。
    方法:在IRB批准后,我们对2012年11月至2021年9月在一所大学附属医疗中心妇科接受SSLF治疗的女性的电子病历进行了回顾性分析.SSLF使用Capio®和Digitex™进行,使用可吸收(polyglactin-910或聚二恶烷酮)缝线(第1组),或永久性(聚丙烯)缝线(第2组),术前和术后评估包括使用盆腔器官脱垂量化系统进行脱垂分期和经过验证的生活质量问卷(盆底窘迫量表和盆腔器官脱垂/尿失禁性问卷-12)。最终分析包括术后12个月时客观和主观结果的患者。解剖学成功定义为术后12个月POP分期<2。为了进行统计分析,Mann-Whitney检验用于连续变量,费舍尔对二分变量的精确检验,>2类变量的独立性和卡方检验。
    结果:在研究期间,234名女性接受了SSLF。在12个月的随访中,有142例患者(60.7%)返回,并纳入最终分析。72例(50.7%)患者使用可吸收缝线,70例(49.3%)患者使用永久性缝线。第1组[100(50-150)cc比50(50-100)cc的估计失血量明显较高,p=.016]。第2组POD-1的中度至重度疼痛明显增高[VAS:2.00(0.00-4.00)vs4.00(3.00-5.75),p=.001]。解剖学上的成功,定义为12个月时的POP≤阶段2,组间相似:第1组为69%,第2组为67%(p=0.77)。两组之间的主观治愈相似,第一组为97.2%,第二组为94.3%(p=0.44)。在12个月的随访中,没有患者出现臀痛。两组之间的新性交困难发生率相似:可吸收缝线组4名女性(5.9%)与永久性缝线组2名女性(3.3%)(p=.49)。
    结论:我们的研究结果表明,可吸收或永久性缝合材料不会影响SSLF的预后。永久性缝合可能与术后即刻疼痛增加有关。
    OBJECTIVE: To evaluate success and safety of sacrospinous ligament fixation (SSLF) using permanent versus absorbable suture materials 12 months following surgery.
    METHODS: Following IRB approval, the electronic medical records of women who underwent SSLF in the gynecology department of a university-affiliated medical center from November 2012 to September 2021 were retrospectively reviewed. SSLF was carried out using Capio®and Digitex™, with either absorbable (polyglactin-910 or polydioxanone) sutures (group 1), or permanent (polypropylene) sutures (group 2), Pre-operative and post-operative assessment included prolapse staging using the pelvic organ prolapse quantification system and validated quality of life questionnaires (Pelvic Floor Distress Inventory and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12). Patients with postoperative information on objective and subjective outcome at 12 months were included in final analysis. Anatomical success was defined as POP stage < 2 at 12-months following surgery. For statistical analysis, the Mann-Whitney test was used for continuous variables, Fisher\'s exact test for dichotomous variables, and Chi-squared test of independence for variables with>2 categories.
    RESULTS: During the study period, 234 women underwent SSLF. One-hundred and forty-two patients (60.7 %) returned at the 12-month follow-up and were included in final analysis. Seventy-two (50.7 %) patients had absorbable suture and 70 patients (49.3 %) had permanent suture. Estimated blood loss was significantly higher in group 1 [100 (50-150) cc vs 50 (50-100) cc respectively, p =.016]. Moderate to severe pain on POD-1 was significantly higher in group 2 [VAS: 2.00 (0.00-4.00) vs 4.00 (3.00-5.75) respectively, p =.001]. Anatomical success, defined as POP ≤ stage 2 at 12 months, was similar between groups: 69 % in group 1 vs 67 % in group 2 (p =.77). Subjective cure was similar between groups, 97.2 % in group 1 vs 94.3 % in group 2 (p =.44). At the 12-month follow-up, none of the patients had gluteal pain. The rate of de-novo dyspareunia was similar between groups: 4 women (5.9 %) in the absorbable suture group versus 2 women (3.3 %) in the permanent suture group (p =.49).
    CONCLUSIONS: Our findings suggest that absorbable or permanent suture material does not affect outcome of SSLF. Permanent sutures may be related to increased immediate postoperative pain.
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  • 文章类型: Journal Article
    背景:为了客观评估安全性,可行性,优势,经阴道自然腔道内镜手术(vNOTES)与传统阴道(CV)手术用于骶棘韧带固定术(SSLF)的缺点。
    方法:我们回顾性分析了2019年4月至2020年4月在我院因根尖室脱垂而通过vNOTES或CV手术进行SSLF子宫切除术的患者资料。根据手术方式,将患者分为vNOTES组(n=31)和CV手术组(n=51),并比较其一般特征和围手术期结果。
    结果:两组具有相似的一般特征。vNOTES组的解剖成功率和双侧输卵管卵巢切除术率高于CV手术组,而vNOTES术后住院时间短于CV手术组。所有差异均有统计学意义。然而,手术时间组间差异无统计学意义,双侧输卵管切除率,检查率,术后视觉模拟量表评分,估计失血量,术后72h血红蛋白下降,术后72h最高体温,并发症发生率,臀部疼痛,术后1年的盆底冲击问卷-7和盆底窘迫问卷-20评分。
    结论:用于SSLF的VNOTES是安全可行的,并且与用于SSLF的CV手术相比,具有优越的客观和主观结果。这些发现表明vNOTES可以替代SSLF的CV手术。
    BACKGROUND: To objectively assess the safety, feasibility, advantages, and disadvantages of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) versus conventional vaginal (CV) surgery for sacrospinous ligament fixation (SSLF).
    METHODS: We retrospectively analyzed the data of patients who underwent hysterectomy for SSLF via vNOTES or CV surgery due to apical compartment prolapse between April 2019 and April 2020 at our hospital. The patients were classified into the vNOTES group (n = 31) and CV surgery group (n = 51) based on surgical approach and their general characteristics and perioperative outcomes compared.
    RESULTS: The two groups had similar general characteristics. The anatomical success and bilateral salpingo-oophorectomy rates were higher in the vNOTES than CV surgery group, while the postoperative stay was shorter in the vNOTES than CV surgery group. All differences were statistically significant. However, there were no statistically significant intergroup differences in operation time, bilateral salpingectomy rate, colporrhaphy rate, postoperative visual analog scale score, estimated blood loss, hemoglobin decrease at 72 h postoperative, maximum body temperature at 72 h postoperative, complication rate, buttock pain, or Pelvic Floor Impact Questionnaire-7 and Pelvic Floor Distress Inventory Questionnaire-20 scores at 1 year postoperative.
    CONCLUSIONS: VNOTES for SSLF was safe and feasible and resulted in superior objective and subjective outcomes versus CV surgery for SSLF. These findings suggest that vNOTES could be an alternative to CV surgery for SSLF.
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  • 文章类型: Journal Article
    目的:探讨骶棘韧带固定术(SSLF)治疗盆腔尖部脏器脱垂的严重并发症及再手术的发生率。方法:这是一项国家注册辅助队列比较研究。VIGI-MESH注册表包括2017年5月至2021年9月期间前瞻性收集的24个法国卫生中心的数据。使用Kaplan-Meier曲线和Log-rank检验探讨了严重并发症或生殖器脱垂复发的再手术时间。治疗加权的逆概率,根据倾向得分,用于调整组间差异。结果:共纳入1359名妇女,并分析了四个手术组:带网片的前SSLF(n=566),带有天然组织的前SSLF(n=331),带网格的后验SSLF(n=57),和具有天然组织的后SSLF(n=405)。Clavien-DindoIII级并发症或更高的病例有34例(2.5%),组间无统计学差异。据报告,44名(3.2%)女性盆腔器官脱垂复发需要再次手术,与前SSLF相比,后SSLF的发生率更高(p=0.0034)。结论:根据本次大数据库辅助研究,骶棘韧带固定术是治疗根尖脱垂安全有效的手术方法。不同的手术入路(前/后和带/不带网片)具有相当的安全性。然而,与后路入路和使用天然组织相比,前路入路和使用网片的再手术风险较低。分别。
    Objective: To evaluate the rates of serious complications and reoperation for recurrence following sacrospinous ligament fixation (SSLF) for apical pelvic organ prolapse. Methods: This was a national registry ancillary cohort comparative study. The VIGI-MESH registry includes data from 24 French health centers prospectively collected between May 2017 and September 2021. Time to occurrence of a serious complication or reoperation for genital prolapse recurrence was explored using the Kaplan-Meier curve and Log-rank test. The inverse probability of treatment weighting, based on propensity scores, was used to adjust for between-group differences. Results: A total of 1359 women were included and four surgical groups were analyzed: Anterior SSLF with mesh (n = 566), Anterior SSLF with native tissue (n = 331), Posterior SSLF with mesh (n = 57), and Posterior SSLF with native tissue (n = 405). Clavien-Dindo Grade III complications or higher were reported in 34 (2.5%) cases, with no statistically significant differences between the groups. Pelvic organ prolapse recurrence requiring re-operation was reported in 44 (3.2%) women, this was higher following posterior compared with anterior SSLF (p = 0.0034). Conclusions: According to this large database ancillary study, sacrospinous ligament fixation is an effective and safe surgical treatment for apical prolapse. The different surgical approaches (anterior/posterior and with/without mesh) have comparable safety profiles. However, the anterior approach and the use of mesh were associated with a lower risk of reoperation for recurrence compared with the posterior approach and the use of native tissue, respectively.
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  • 文章类型: Observational Study
    目的:骶棘韧带(SSL)固定术是一种有效且广泛使用的矫正根尖脱垂的阴道手术。藏红花固定系统(ColoplastCorp.,明尼阿波利斯,MN,美国)是一种新的锚定装置,旨在促进耐用,easy,SSL固定的简短程序,目的是最大程度地减少手术并发症。目的是证明使用藏红花固定系统进行骨盆器官脱垂修复的锚钉部署和缝线固定的有效性和安全性。
    方法:进行了一项观察性人体尸体研究,以测量锚点位置与骨盆解剖标志之间的距离,和固定锚的保持力。通过不同的植入器将锚放置在四个人类尸体中。测量这些锚的拔出力以评估功效(三个尸体由三个植入者),并且测量锚与原始血管和神经之间的距离以评估安全性(一个尸体由一个植入者)。
    结果:根据非植入外科医生的独立评估判断,20个锚钉中的19个(95%)正确放置。锚与周围神经和血管之间的距离超过10mm。平均(SD)拔出力为17.9(5.6)N。
    结论:开发的创新锚固装置似乎能够在SSL中实现精确和牢固的锚固放置。需要未来的临床研究来探索与可用的缝合和锚固装置相比,该装置的理论优势是否转化为改善的临床结果。
    Sacrospinous ligament (SSL) fixation is an effective and widely used vaginal procedure for correcting apical prolapse. The Saffron Fixation System (Coloplast Corp., Minneapolis, MN, USA) is a new anchoring device aimed at facilitating a durable, easy, and short procedure for SSL fixation with the goal of minimizing operative complications. The objective was to demonstrate the efficacy and safety of anchor deployment and suture fixation for pelvic organ prolapse repair using the Saffron Fixation System.
    An observational human cadaver study was conducted to measure the distance between anchor location and anatomical landmarks in the pelvis, and the holding force of the fixated anchors. Anchors were placed in four human cadavers by different implanters. The pull-out force of these anchors was measured to assess efficacy (three cadavers by three implanters) and the distance between anchors and primal vessels and nerves was measured to assess safety (one cadaver by one implanter).
    Nineteen out of 20 anchors (95%) were correctly placed as judged by independent assessment performed by non-implanting surgeons. Distance between anchors and surrounding nerves and vessels exceeded 10 mm. Mean (SD) pull out-force was 17.9 (5.6) N.
    The innovative anchoring device that was developed appeared to enable precise and solid anchor placement in the SSL. Future clinical studies are needed to explore if the theoretical advantages of this device translate to improved clinical outcomes in comparison with available suturing and anchoring devices.
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