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Current opinion on large-scale prospective myomectomy databases toward evidence-based preconception and antenatal counselling utilising a standardised myomectomy operation note. 关于大规模前瞻性子宫肌瘤切除术数据库的当前观点,利用标准化子宫肌瘤切除术手术记录,开展循证孕前和产前咨询。
IF 1.7 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2024-03-01 DOI: 10.52054/FVVO.16.4.006
S M Strong, A A McDougall, A M Abdelmohsen, A Maku, A Dehnel, R Mallick, F Odejinmi

Background: No large-scale databases exist of pregnancy outcomes and rate of uterine rupture for women after myomectomy, resulting in inconsistent antenatal counselling and decision-making regarding mode and timing of delivery. Standardising information collected at myomectomy may facilitate data collection, informing prenatal/ antenatal counselling.

Objectives: To determine clinician opinions regarding standardisation of myomectomy operation notes to allow comprehensive data input into a prospective database of pregnancy outcomes, toward an evidence-based approach to decision making regarding timing and mode of delivery in subsequent pregnancies.

Materials and methods: A google forms survey was emailed to all consultant (attending-level) obstetricians and gynaecologists across 25 hospitals in London, Kent, Surrey, and Sussex (UK) between March and May 2022. To enhance response rates, two further email reminders were sent alongside in-person reminders from selected local unit representatives.

Main outcome measures: Senior clinician opinion for characteristics necessary to collect at time of surgery to develop a widescale database of post myomectomy pregnancy outcomes.

Results: 209/475 (44%) responses received; 95% (198/209) agreed with standardising operation notes. Criteria selected for inclusion included cavity breach (98%, 194/198), location (98%, 194/198), number of fibroids removed (93%, 185/198) and number of uterine incisions (96%, 190/198).

Conclusions: Gynaecologists support standardising myomectomy operation notes to inform the development of prospective large-scale databases of pregnancy outcomes after myomectomy.

What is new?: Acquisition of clinician opinions on the development and content of a standardised myomectomy operation note to aid the development of a pregnancy-outcome database for women after myomectomy.

背景:目前还没有关于子宫肌瘤剔除术后妇女妊娠结局和子宫破裂率的大规模数据库,导致产前咨询和分娩方式及时机决策不一致。将子宫肌瘤剔除术时收集的信息标准化可促进数据收集,为产前/产后咨询提供依据:目的:确定临床医生对子宫肌瘤剔除术手术记录标准化的意见,以便将全面的数据输入妊娠结局前瞻性数据库,从而为后续妊娠的分娩时间和方式决策提供循证方法:2022 年 3 月至 5 月期间,通过电子邮件向英国伦敦、肯特、萨里和苏塞克斯 25 家医院的所有妇产科顾问(主治医师)发送了谷歌表格调查。为提高回复率,我们还发送了两封邮件提醒,并由选定的当地单位代表亲自进行提醒:结果:收到 209/475 份回复(44%);95%(198/209)同意标准化手术记录。选择纳入的标准包括子宫腔破损(98%,194/198)、位置(98%,194/198)、肌瘤剔除数量(93%,185/198)和子宫切口数量(96%,190/198):妇科医生支持对子宫肌瘤剔除术手术记录进行标准化,以便为开发子宫肌瘤剔除术后妊娠结局的前瞻性大规模数据库提供信息:就标准化子宫肌瘤剔除术手术记录的开发和内容征求临床医生的意见,以帮助开发子宫肌瘤剔除术后妇女妊娠结局数据库。
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引用次数: 0
The Clinical Significance of Subtle Distal Fallopian Tube Abnormalities: A Multicentre Prospective Observational Study. 输卵管远端微小异常的临床意义:一项多中心前瞻性观察研究。
IF 1.7 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2024-03-01 DOI: 10.52054/FVVO.16.1.007
X Zheng, X Yu, X Xie, G Lyu, J Niu, X Li, H Chen, A Watrelot, J Guan

Background: Subtle distal fallopian tube abnormalities are a group of diseases characterised by small variations in tubal anatomy. The clinical significance of these abnormalities need to be studied.

Objectives: The purpose of this multicentre prospective observational study was to investigate whether subtle distal fallopian tube abnormalities are related to infertility and endometriosis.

Materials and methods: The investigation was carried out in five medical centres in China and France from February to July 2021 and included reproductive-age patients who underwent gynaecological laparoscopy. Subtle abnormalities included Hydatid of Morgagni (HM) , fimbrial agglutination, tubal diverticula, accessory ostium, fimbrial phimosis, and accessory fallopian tube.

Results: 642 patients were enrolled in the study and 257 (40.0%) were diagnosed with subtle tube abnormalities. Hydatid of Morgagni was the most common abnormality (22.7%; n=146), followed by fimbrial agglutination (19.8%; n=127), tubal diverticula (6.9%; n=44), accessory tube (2.0%; n=13), and tubal accessory ostium (1.9%; n=12). Fimbrial phimosis was the least common abnormality (0.3%; n=2). The prevalence of subtle fallopian tube abnormalities was significantly higher among infertile patients (188/375, 50.1%) than those without history of infertility (69/267, 25.8%, ᶍ2=38.332, P=0.000). 209 patients were diagnosed with endometriosis during surgery, and the prevalence of subtle abnormalities was significantly higher in the endometriosis group than in those without endometriosis (61.2%, [128/209] vs. 29.8% [129/433], ᶍ2=58.086, P=0.000).

Conclusions: Higher prevalence of subtle tubal abnormalities suggests that they may contribute to infertility. They are highly related to endometriosis and indicate fimbrial abnormalities of endometriosis.

What is new?: This is the largest multicentre study to investigate the subtle distal fallopian tube abnormalities in infertile women. Compared to previous studies, this study includes the main subtle distal abnormalities and the control group patients without a history of infertility.

背景:输卵管远端微小异常是一组以输卵管解剖结构的微小变化为特征的疾病。需要研究这些异常的临床意义:这项多中心前瞻性观察研究的目的是调查细微的输卵管远端异常是否与不孕症和子宫内膜异位症有关:调查于2021年2月至7月在中国和法国的五个医疗中心进行,包括接受妇科腹腔镜检查的育龄患者。细微异常包括莫加尼水瘤(HM)、绒毛凝集、输卵管憩室、输卵管伞端、绒毛阴道炎和输卵管伞端:研究共登记了 642 名患者,其中 257 人(40.0%)被诊断为输卵管微小异常。莫加尼水瘤是最常见的异常(22.7%;n=146),其次是边缘凝集(19.8%;n=127)、输卵管憩室(6.9%;n=44)、附属输卵管(2.0%;n=13)和输卵管附属孔(1.9%;n=12)。阴茎包皮过长是最不常见的异常(0.3%;n=2)。不孕患者中细微输卵管异常的发生率(188/375,50.1%)明显高于无不孕史者(69/267,25.8%,ᶍ2=38.332,P=0.000)。209名患者在手术过程中被诊断出患有子宫内膜异位症,子宫内膜异位症组的细微异常发生率明显高于无子宫内膜异位症组(61.2% [128/209] vs. 29.8% [129/433],ᶍ2=58.086,P=0.000):结论:隐匿性输卵管异常的发病率较高,这表明它们可能是导致不孕的原因之一。结论:隐匿性输卵管异常的发生率较高,表明它们可能是导致不孕的原因之一,它们与子宫内膜异位症高度相关,表明子宫内膜异位症的输卵管异常:这是调查不孕妇女输卵管远端微小异常的最大规模多中心研究。与之前的研究相比,本研究包括了主要的细微远端异常和无不孕史的对照组患者。
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引用次数: 0
Reproducibility of #Enzian classification by transvaginal ultrasound and its correlation with symptoms. 经阴道超声对 #Enzian 分类的再现性及其与症状的相关性。
IF 1.7 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2024-03-01 DOI: 10.52054/FVVO.16.1.008
C Russo, L Lazzeri, T Siciliano, A Selntigia, D Farsetti, C Chiaramonte, F G Martire, E Zupi, C Exacoustos

Background: The #Enzian classification represents a system to describe endometriotic lesions during surgery. Its use is well established in correlating ultrasound and surgical findings.

Objectives: To describe interobserver reproducibility of ultrasound use and symptom correlation with compartments involved using #Enzian classification.

Materials and methods: Two experienced operators performed transvaginal sonography (TVS) in 52 patients affected by pelvic endometriosis. A rate agreement was determined. A further 200 women with endometriotic TVS signs, with no previous surgery and not taking any hormonal therapy, were staged by one of three different operators according to the #Enzian (compartments A, B, C, O, T, FA, FB, FI, FU, FO). Statistical analysis compared all the compartments, as single or associated, with single or combined symptoms (dysmenorrhea, dyspareunia, heavy menstrual bleeding - HMB, bowel symptoms).

Main outcome measures: Evaluation of the reproducibility of #Enzian classification in assessing pelvic endometriosis among different operators using TVS, and of possible associations between symptoms and specific #Enzian compartments.

Results: Excellent agreement between the two operators in evaluating almost all the compartments (k >0.8) was observed. Dysmenorrhea did not correlate with any specific compartment. We observed a significant association between dyspareunia and B compartment (p=0.02). HMB is associated with FA (p=0.02). Bowel symptoms were associated with B (p=0.02). Combining more symptoms, we observed more significant associations with different compartments.

Conclusions: #ENZIAN classification is reproducible in the evaluation of pelvic endometriosis. Some symptoms are correlated to specific ultrasound signs of the disease.

What is new?: An accurate evaluation of symptoms could guide TVS examination to detect specific endometriotic lesions and establish the best management for the patients.

背景:恩氏分类法是在手术过程中描述子宫内膜异位症病变的系统。其在关联超声和手术结果方面的应用已得到广泛认可:材料与方法:由两名经验丰富的操作者进行经阴道超声检查:材料: 两名经验丰富的操作者对 52 名盆腔子宫内膜异位症患者进行了经阴道超声检查(TVS)。确定了一致率。另外 200 名有子宫内膜异位症 TVS 征兆的妇女,既往未做过手术,也未服用过任何激素治疗,由三名不同操作者之一根据 #Enzian (A、B、C、O、T、FA、FB、FI、FU、FO 区)进行分期。统计分析比较了所有分区的单一或相关症状,以及单一或合并症状(痛经、排便困难、月经大量出血 - HMB、肠道症状):评估不同操作者使用 TVS 评估盆腔子宫内膜异位症时#Enzian 分类的可重复性,以及症状与特定#Enzian 区间可能存在的关联:结果:两位操作者对几乎所有分区的评估都非常一致(k>0.8)。痛经与任何特定分区无关。我们观察到痛经与 B 室有明显的相关性(p=0.02)。HMB与FA相关(P=0.02)。肠道症状与 B 区相关(P=0.02)。结合更多症状,我们观察到不同分区之间存在更显著的关联:结论:在评估盆腔子宫内膜异位症时,#ENZIAN分类法具有可重复性。结论:#ENZIAN分类法在评估盆腔子宫内膜异位症时具有可重复性,某些症状与该疾病的特定超声征象相关:对症状的准确评估可指导 TVS 检查发现特定的子宫内膜异位症病灶,并为患者制定最佳治疗方案。
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引用次数: 0
The first robotic-assisted hysterectomy below the bikini line with the Dexter robotic system™. 首次使用 Dexter 机器人系统™进行比基尼线以下的机器人辅助子宫切除术。
IF 1.7 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2024-03-01 DOI: 10.52054/FVVO.16.1.010
I Alkatout, T Becker, P Nuhn, J Pochhammer, G Peters, K M Donald, L Mettler, J Ackermann

Background: Robotic-assisted hysterectomy (RAH) is a widely accepted minimally invasive approach for uterus removal. However, as RAH is typically performed in the umbilical region, it usually results in scars in cosmetically suboptimal locations. This is the first case of RAH with cervicosacropexy performed below the bikini line, using the new Dexter robotic system™.

Objectives: The aim of this article is to show the surgical steps of the first RAH with cervicosacropexy performed below the bikini line with the new Dexter robotic system™ (Distalmotion), and furthermore assess the feasibility of this approach using this robotic platform.

Materials and methods: A 43-year-old woman with uterine adenomyosis and recurrent uterine prolapse underwent a robotic-assisted subtotal hysterectomy with cervicosacropexy, performed below the bikini line, using the Dexter robotic system™, at the Clinic of Gynecology and Obstetrics at Universitätsklinikum Schleswig-Holstein (UKHS) in Kiel, Germany.

Main outcome measures: Perioperative data, surgical approach specifics, objective, and subjective outcomes of this new approach.

Results: The procedure was performed without intra-operative complications; estimated blood loss was 10 ml. Operative time was 150 minutes, console time 120 minutes, total docking time 6 minutes. Dexter performed as expected; no device-related issues or robotic arm collisions occurred. The patient did not require pain medication and was released on the second postoperative day.

Conclusion: RAH performed below the bikini line using the Dexter robotic system™ is a feasible, safe, and adequate procedure. These initial results should be confirmed and further extensively refurbished with larger patient cohorts, and functional and psychological outcomes need further investigation.

背景:机器人辅助子宫切除术(RAH)是一种广为接受的微创子宫切除术。然而,由于 RAH 通常在脐部区域进行,因此通常会在外观不理想的位置留下疤痕。本文是首例使用新型 Dexter 机器人系统™在比基尼线下进行 RAH 和宫颈骶骨切除术的病例:本文旨在展示首例使用新型 Dexter 机器人系统™(Distalmotion)在比基尼线下进行 RAH 伴颈骶骨切除术的手术步骤,并进一步评估使用该机器人平台进行该手术的可行性:一名患有子宫腺肌病和复发性子宫脱垂的43岁女性在德国基尔市石勒苏益格-荷尔斯泰因大学妇产科诊所(UKHS)接受了机器人辅助子宫次全切除术和宫颈骶骨切除术,手术在比基尼线下进行,使用的是Dexter机器人系统™:主要结果指标:围手术期数据、手术方法的具体细节、这种新方法的客观和主观结果:手术无术中并发症;估计失血量为 10 毫升。手术时间为 150 分钟,控制台时间为 120 分钟,总对接时间为 6 分钟。Dexter 的表现符合预期;没有发生与设备相关的问题或机械臂碰撞。患者无需服用止痛药,术后第二天即可出院:结论:使用 Dexter 机器人系统™ 在比基尼线下进行 RAH 是一种可行、安全且适当的手术。这些初步结果应在更大的患者群体中得到证实和进一步广泛的验证,功能和心理结果也需要进一步调查。
{"title":"The first robotic-assisted hysterectomy below the bikini line with the Dexter robotic system™.","authors":"I Alkatout, T Becker, P Nuhn, J Pochhammer, G Peters, K M Donald, L Mettler, J Ackermann","doi":"10.52054/FVVO.16.1.010","DOIUrl":"10.52054/FVVO.16.1.010","url":null,"abstract":"<p><strong>Background: </strong>Robotic-assisted hysterectomy (RAH) is a widely accepted minimally invasive approach for uterus removal. However, as RAH is typically performed in the umbilical region, it usually results in scars in cosmetically suboptimal locations. This is the first case of RAH with cervicosacropexy performed below the bikini line, using the new Dexter robotic system™.</p><p><strong>Objectives: </strong>The aim of this article is to show the surgical steps of the first RAH with cervicosacropexy performed below the bikini line with the new Dexter robotic system™ (Distalmotion), and furthermore assess the feasibility of this approach using this robotic platform.</p><p><strong>Materials and methods: </strong>A 43-year-old woman with uterine adenomyosis and recurrent uterine prolapse underwent a robotic-assisted subtotal hysterectomy with cervicosacropexy, performed below the bikini line, using the Dexter robotic system™, at the Clinic of Gynecology and Obstetrics at Universitätsklinikum Schleswig-Holstein (UKHS) in Kiel, Germany.</p><p><strong>Main outcome measures: </strong>Perioperative data, surgical approach specifics, objective, and subjective outcomes of this new approach.</p><p><strong>Results: </strong>The procedure was performed without intra-operative complications; estimated blood loss was 10 ml. Operative time was 150 minutes, console time 120 minutes, total docking time 6 minutes. Dexter performed as expected; no device-related issues or robotic arm collisions occurred. The patient did not require pain medication and was released on the second postoperative day.</p><p><strong>Conclusion: </strong>RAH performed below the bikini line using the Dexter robotic system™ is a feasible, safe, and adequate procedure. These initial results should be confirmed and further extensively refurbished with larger patient cohorts, and functional and psychological outcomes need further investigation.</p>","PeriodicalId":46400,"journal":{"name":"Facts Views and Vision in ObGyn","volume":"16 1","pages":"87-91"},"PeriodicalIF":1.7,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11198885/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140319469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Breast cancer screening in women taking hormone replacement therapy needs updating. 需要对接受激素替代疗法的妇女进行乳腺癌筛查。
IF 1.7 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2024-03-01 DOI: 10.52054/FVVO.16.1.001
P R Koninckx, A Ussia, G Page

Breast cancer screening by mammography is widely used. The diagnostic accuracy is limited, with a positive predictive value of 16%. Therefore, a stepwise investigation, with repeat mammography and confirmation by pathology, is usually proposed. Although this stepwise investigation intends to avoid overtreatment, the many false positives result in unnecessary fear and diagnostic surgery in many women. The false negatives are not known since these women have not been investigated. Given the estimated low risk of missing breast cancer and the slow growth, repeating a screening mammography every two years is sufficient. The false positive screening results, increase with breast density, and breast density increases when hormone replacement therapy (HRT) is given. It, therefore, is suggested to use clinical judgment and stop HRT for 3 to 6 months before repeating the mammography instead of starting immediately a stepwise investigation in all women.

乳房 X 射线照相术被广泛应用于乳腺癌筛查。其诊断准确性有限,阳性预测值仅为 16%。因此,通常建议采用分步检查法,即重复乳房 X 光检查和病理确认。虽然这种分步检查的目的是避免过度治疗,但许多假阳性结果会给许多妇女带来不必要的恐惧和诊断性手术。由于没有对这些妇女进行调查,因此无法得知假阴性结果。据估计,乳腺癌漏诊的风险很低,而且生长缓慢,因此每两年重复一次乳房 X 线照相筛查就足够了。假阳性筛查结果会随着乳腺密度的增加而增加,而在使用激素替代疗法(HRT)时,乳腺密度也会增加。因此,建议根据临床判断,停止激素替代疗法 3 至 6 个月后再重复乳房 X 光检查,而不是立即对所有妇女进行逐步检查。
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引用次数: 0
Defining a Uterine Extraction Score based on a Volume/Access Ratio in Total Hysterectomy: a retrospective cohort study. 根据全子宫切除术中的体积/容积比定义子宫切除评分:一项回顾性队列研究。
IF 1.7 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2024-03-01 DOI: 10.52054/FVVO.16.1.009
S Schoenen, L de Landsheere

Background: Regardless of the technique used, extraction of the uterus is a crucial step in hysterectomy. There is currently no scoring system to predict its feasibility.

Objectives: Our main objective was to determine a predictive score of uterine extraction feasibility to optimise surgical planning of total hysterectomy. As secondary objectives, we examined the correlation between uterine volume predicted by preoperative ultrasound and the final weight of the surgical specimen and analysed the impact of the uterine extraction modality on operative and hospitalisation times.

Materials and methods: We defined a Uterine Extraction Score (UES) based on the ratio between uterine sizes and vaginal access. This score was retrospectively applied to a cohort of 178 patients who were hysterectomised for benign conditions between January 2019 and December 2022.

Main outcome measures: The UES allows identification of three groups of decreasing feasibility of vaginal extraction, symbolised by traffic light colours: green - vaginal extraction without morcellation, orange -vaginal extraction with morcellation, red - abdominal morcellation by mini-laparotomy or primary laparotomy.

Results: The results show that the UES--predicted, and the observed routes of extraction concord in 92% of cases. There is a strong correlation between estimated volume and final uterine weight. Uterine morcellation lengthens the operative time and the hospital stay.

Conclusions: The UES seems to be a reliable tool to predict the route of uterine extraction in total hysterectomy.

What is new?: The development of a new scoring system empowers surgeons with decisive information to enhance perioperative outcomes.

背景:无论采用何种技术,摘除子宫都是子宫切除术的关键步骤。目前还没有预测其可行性的评分系统:我们的主要目的是确定子宫摘除术可行性的预测评分,以优化全子宫切除术的手术计划。作为次要目标,我们研究了术前超声预测的子宫体积与手术标本最终重量之间的相关性,并分析了子宫摘除术方式对手术和住院时间的影响:我们根据子宫大小和阴道通路之间的比率定义了子宫摘除评分(UES)。该评分被回顾性地应用于2019年1月至2022年12月期间因良性疾病而切除子宫的178名患者队列中:主要结果测量:通过 UES,可以识别出三组阴道摘除术可行性递减的患者,并用交通灯颜色表示:绿色--不进行阴道摘除术,橙色--进行阴道摘除术,红色--通过小腹膜切口或主腹膜切口进行腹腔摘除术:结果表明,在92%的病例中,预测的UES和观察到的取出途径是一致的。估计体积与最终子宫重量之间有很强的相关性。子宫切除术延长了手术时间和住院时间:UES似乎是预测全子宫切除术中子宫取出路径的可靠工具:新评分系统的开发为外科医生提供了提高围手术期效果的决定性信息。
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引用次数: 0
Innovative Cadaveric Technique: Utilising n-Butyl Cyanoacrylate (n-BCA) for Deep Endometriosis Excision Simulation in Minimal Invasive Surgery Training. 创新的尸体技术:在微创手术培训中利用氰基丙烯酸正丁酯(n-BCA)模拟子宫内膜异位症深部切除术。
IF 1.7 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2024-03-01 DOI: 10.52054/FVVO.16.1.002
M Mabrouk, S Mahgoub, A Vashisht, R Seracchioli

Background: Our study aimed to create a novel technique using n-butyl cyanoacrylate (n-BCA) for minimal access simulation training on cadavers in deep endometriosis excision.

Objectives: A step-by-step video demonstration of using n-BCA in cadavers to simulate deep endometriosis. This technique is integrated into training sessions using cadavers aimed at enhancing surgical proficiency for deep endometriosis procedures.

Material and methods: Video article describing using n-BCA in cadavers as a simulation model.

Result: This technique has been used in a hands-on cadaveric training course, and positive feedback supports the recommendation to incorporate this technique.

Conclusion: Utilizing a human cadaver model proves beneficial for enhancing understanding of deep pelvic innervation. Implementing n-BCA in these cadaver dissections demonstrates both reproducibility and safety. This approach significantly contributes to refining surgical expertise in the excision of deep infiltrating endometriosis.

背景:我们的研究旨在利用氰基丙烯酸正丁酯(n-BCA)创建一种新技术,用于在尸体上进行子宫内膜异位症深部切除术的微创模拟训练:通过视频逐步演示如何在尸体上使用 n-BCA模拟深部子宫内膜异位症。材料与方法:描述在尸体中使用 n-BCA 作为模拟模型的视频文章:结果:这一技术已在尸体实践培训课程中使用,积极的反馈支持将这一技术纳入培训课程的建议:结论:使用人体尸体模型有利于加深对骨盆深层神经支配的理解。在这些尸体解剖中采用 n-BCA 技术证明了其可重复性和安全性。这种方法大大有助于完善切除深部浸润性子宫内膜异位症的手术技巧。
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引用次数: 0
Lessons learnt from the multi-centre LAparoscopic Versus Abdominal hysterectomy (LAVA) randomised controlled trial. 从多中心 LAparoscopic Vus Abdominal hysterectomy(LAVA)随机对照试验中汲取的经验教训。
IF 1.7 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2024-03-01 DOI: 10.52054/FVVO.16.1.003
L Antoun, S Bevan, A Mahmud, L Jones, L Middleton, R Woolley, P Smith, B Z Fatemah Sairally, E Saridogan, K Cooper, T J Clark

Background: The LAparoscopic Versus Abdominal hysterectomy (LAVA) randomised controlled trial comparing laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH) closed prematurely on the grounds of futility. Here we identify the challenges faced and lessons learnt.

Objectives: To explore the views and experiences of clinical/research staff in order to understand how these might act as barriers to trial participation and recruitment.

Materials and methods: Review of the trial progress and collation of the views and experiences of clinical/ research staff on all aspects of the trial. Data were collected from transcribed conversations, email, phone, or video conferencing interactions and analysed descriptively.

Main outcome measures: Site set-up milestones, recruitment rates and reasons provided by clinical/research staff for site's declining to participate. Opinions, preferences and experiences of clinicians/researchers and challenges to participation and recruitment.

Results: The mean time from initial site contact to opening was 253 days and 68 days to randomise their first participant. 265 patients were screened from 13 sites over 13 months, 154 were eligible, and 75 (59%) were randomised. Of the 53 not randomised, 23 (43%) women preferred LH whilst 6 (11%) preferred AH. The main reasons given for failure to recruit or activate set-up in the 21 sites open or in set-up, were lack of research/ clinical capacity imposed by the COVID-19 pandemic and lack of clinician equipoise.

Conclusions: The main reasons for the LAVA trial failure were lack of equipoise amongst surgeons and the adverse impact of the COVID-19 pandemic on clinical/research services.

What is new?: Surgeons' preference for laparoscopic hysterectomy is not shared by most patients. Many patients prefer an open hysterectomy to a laparoscopic one.

背景:腹腔镜与腹腔镜子宫切除术(LAVA)随机对照试验比较了腹腔镜子宫切除术(LH)和腹腔镜子宫切除术(AH),该试验因无效而提前结束。在此,我们指出了面临的挑战和吸取的教训:探讨临床/研究人员的观点和经验,以了解这些观点和经验如何成为试验参与和招募的障碍:回顾试验进展,整理临床/研究人员对试验各方面的看法和经验。通过谈话记录、电子邮件、电话或视频会议互动收集数据,并进行描述性分析:主要结果测量指标:研究机构设立的里程碑、招募率以及临床/研究人员提供的研究机构拒绝参与的原因。临床医生/研究人员的意见、偏好和经验,以及参与和招募所面临的挑战:从最初与研究机构联系到开始研究的平均时间为 253 天,而随机分配第一名参与者的平均时间为 68 天。在 13 个月的时间里,13 个研究机构共筛选出 265 名患者,其中 154 人符合条件,75 人(59%)被随机分配。在 53 名未被随机选中的患者中,23 名(43%)女性选择 LH,6 名(11%)选择 AH。在 21 个开放或正在筹建的医疗点中,未能招募或启动设置的主要原因是 COVID-19 大流行导致研究/临床能力不足,以及临床医生缺乏默契:LAVA试验失败的主要原因是外科医生之间缺乏共识,以及COVID-19大流行对临床/研究服务的不利影响:外科医生对腹腔镜子宫切除术的偏好并不为大多数患者所认同。与腹腔镜子宫切除术相比,许多患者更喜欢开腹子宫切除术。
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引用次数: 0
Perspectives in adhesion prevention in gynaecological surgery. 妇科手术中预防粘连的前景。
IF 2 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2023-12-01 DOI: 10.52054/FVVO.15.4.108
L A Torres-de la Roche, U Catena, T J Clark, R Devassy, N Leyland, R L De Wilde

Adhesions are a frequent, clinically relevant, and often costly complication of surgery that can develop in any body location regardless of the type of surgical procedure. Adhesions result from surgical trauma inducing inflammatory and coagulation processes and to date cannot be entirely prevented. However, the extent of adhesion formation can be reduced by using good surgical technique and the use of anti-inflammatory drugs, haemostats, and barrier agents. Strategies are needed in the short-, medium- and longer-term to improve the prevention of adhesions. In the short-term, efforts are needed to increase the awareness amongst surgeons and patients about the potential risks and burden of surgically induced adhesions. To aid this in the medium- term, a risk score to identify patients at high risk of adhesion formation is being developed and validated. Furthermore, available potentially preventive measures need to be highlighted. Both clinical and health economic evaluations need to be undertaken to support the broad adoption of such measures. In the longer- term, a greater understanding of the pathogenic processes leading to the formation of adhesions is needed to help identify effective, future treatments to reliably prevent adhesions from forming and lyse existing ones.

粘连是一种常见的临床相关并发症,而且往往代价高昂,无论手术类型如何,粘连都可能发生在身体的任何部位。粘连是由手术创伤引起的炎症和凝血过程造成的,至今无法完全避免。不过,通过使用良好的手术技术和使用消炎药、止血剂和屏障剂,可以减少粘连形成的程度。需要采取短期、中期和长期策略来改善粘连的预防。在短期内,需要努力提高外科医生和患者对手术引起粘连的潜在风险和负担的认识。中期而言,为帮助实现这一目标,目前正在开发和验证一种风险评分方法,用于识别有粘连形成高风险的患者。此外,还需要强调现有的潜在预防措施。需要进行临床和卫生经济评估,以支持广泛采用此类措施。从长远来看,需要进一步了解导致粘连形成的致病过程,以帮助确定有效的未来治疗方法,从而可靠地防止粘连形成并溶解现有粘连。
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引用次数: 0
Postoperative Peritoneal Granulomatous Inflammation After the Application of Potato Starch-Based Anti-Adhesive Agent in Laparoscopic Endometriosis Surgery. 腹腔镜子宫内膜异位症手术中应用马铃薯淀粉类抗粘剂后的腹膜肉芽肿性炎症
IF 2 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2023-12-01 DOI: 10.52054/FVVO.15.4.105
H Krentel, A Naem, A Tannapfel, R Devassy, A S Constantin, R L De Wilde

Background: Endometriosis is a chronic inflammatory oestrogen-dependent disease. It is characterised by elevated inflammatory markers in the peritoneal milieu with subsequent adhesiogenesis. Nowadays, excisional, and ablative surgeries are considered the main treatment of endometriosis, and adhesiolysis is being performed almost routinely during these procedures. Postoperative adhesion formation is a significant concern for many surgeons, especially as endometriosis patients are assumed to be predisposed to adhesiogenesis. In order to minimise adhesiogenesis after endometriosis surgery, the usage of different barrier methods have been discussed in the literature. Recent studies aim to investigate the effect of potato starch preparations on adhesion formation in endometriosis patients.

Objectives: We aim to describe the findings of a second-look laparoscopy on patients who received a starch-based anti-adhesive agent.

Materials and methods: We present a retrospective case series that included the medical, surgical, and histopathologic data of three patients.

Main outcome measures: Intraperitoneal adhesion formation and peritoneal inflammation.

Results: All three patients had de-novo adhesions during the second-look laparoscopy. Pathological examination revealed noncaseating granulomatosis of the peritoneum in all patients.

Conclusion: The use of potato starch-based agents as a peritoneal adhesion prophylaxis in laparoscopic endometriosis surgery could lead to granulomatous peritoneal inflammation. Correct application by avoiding powder remnants through complete rinsing and transformation to gel seems to be an important factor to avoid this adverse effect.

What is new?: We aim to highlight that potato starch-based anti-adhesive agents similar to the one used in this study could be a cause of adhesiogenesis and peritoneal inflammation.

背景:子宫内膜异位症是一种依赖雌激素的慢性炎症性疾病:子宫内膜异位症是一种依赖雌激素的慢性炎症性疾病。其特点是腹膜环境中的炎症标志物升高,继而产生粘连。目前,切除和消融手术被认为是治疗子宫内膜异位症的主要方法,而粘连溶解几乎是这些手术的常规操作。术后粘连的形成是许多外科医生非常关注的问题,尤其是子宫内膜异位症患者被认为容易发生粘连。为了尽量减少子宫内膜异位症术后粘连的发生,文献中讨论了使用不同的屏障方法。最近的研究旨在探讨马铃薯淀粉制剂对子宫内膜异位症患者粘连形成的影响:我们旨在描述接受过淀粉类抗粘连剂治疗的患者的二次腹腔镜检查结果:主要结果指标:腹腔内粘连形成和腹膜炎症:结果:三位患者在二次腹腔镜检查时均出现了新的粘连。病理检查显示所有患者的腹膜均有非酪氨酸肉芽肿:结论:在腹腔镜子宫内膜异位症手术中使用马铃薯淀粉制剂作为腹膜粘连预防剂可能会导致肉芽肿性腹膜炎。通过完全冲洗避免粉末残留并转化为凝胶来正确使用似乎是避免这种不良影响的一个重要因素:我们旨在强调,与本研究中使用的马铃薯淀粉类抗粘连剂类似的抗粘连剂可能会导致粘连生成和腹膜炎症。
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引用次数: 0
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Facts Views and Vision in ObGyn
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