Journal of minimally invasive gynecology最新文献_第8页

Minimally Invasive Single-Port Laparoscopic Treatment of a Serous Borderline Ovarian Cyst During Pregnancy. 单孔腹腔镜微创治疗妊娠期浆液性边界卵巢囊肿

IF 3.5 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Journal of minimally invasive gynecology

Pub Date : 2024-11-07 DOI: 10.1016/j.jmig.2024.11.001

Fabio Barra, Giovanni De Vito, Angela Iasci, Stefano Bogliolo

引用次数: 0

Spontaneous Uterine Rupture in Pregnancy After Treatment of Asherman Syndrome. 阿舍曼综合征治疗后的妊娠自发性子宫破裂。

IF 3.5 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Journal of minimally invasive gynecology

Pub Date : 2024-11-07 DOI: 10.1016/j.jmig.2024.11.003

Anouk M Bos, Karlijn C Vollebregt, Miriam F Hanstede

Study objective: Women with Asherman syndrome are at high risk of recurrent adhesions and pregnancy complications. Spontaneous uterine rupture is a rare but life-threatening complication, associated with severe maternal and fetal morbidity and mortality. Uterine ruptures can occur after extended induction of labor or a history of cesarean section, whereas spontaneous uterine rupture in an unscarred uterus is rare. Aim of this study is to evaluate the incidence of spontaneous uterine rupture among women with Asherman syndrome treated by hysteroscopy and without a history of cesarean section.

Design: Prospective cohort study.

Setting: Asherman Expertise Center of the Spaarne Gasthuis, The Netherlands.

Patients: Women were defined by as patients with Asherman syndrome when they had one or more clinical features and the presence of hysteroscopically confirmed intrauterine adhesions.

Interventions: Hysteroscopic adhesiolysis and a second-look hysteroscopy two months after the initial procedure.

Measurements and results: Data on the severity of adhesions and ongoing pregnancy after treatment were collected prospectively. A total of 428 women with Asherman syndrome were included, 4 women (0.9%) experienced spontaneous uterine rupture. The timing varied, none of the affected women were in active labor and the occurrence of uterine rupture was not related to the severity of adhesions. Ruptures were all found in the fundus. One woman had a history of perforation of the uterine wall located in the fundus. Neonatal outcomes were poor, two cases had intrauterine neonatal death and two cases had long-term lifelong disability. One woman had a second uterine rupture.

Conclusion: Women with Asherman syndrome are at risk of uterine rupture, a pregnancy complication with significant consequences that is challenging to predict and may also be associated with history of uterine perforation. Clinicians should be aware of this risk in women treated with hysteroscopic adhesiolysis and consider counseling these patients accordingly prior to treatment.

研究目的患有阿什曼综合征的妇女极易反复发生粘连和妊娠并发症。自发性子宫破裂是一种罕见但危及生命的并发症，与产妇和胎儿的严重发病率和死亡率相关。子宫破裂可能发生在引产时间过长或有过剖宫产史的情况下，而无瘢痕子宫的自发性子宫破裂则很少见。本研究旨在评估经宫腔镜治疗且无剖宫产史的阿瑟曼综合征妇女自发性子宫破裂的发生率：前瞻性队列研究：地点：荷兰Spaarne Gasthuis阿瑟曼专家中心：干预措施：宫腔镜粘连分解术和剖宫产术：干预措施：宫腔镜粘连溶解术和首次手术两个月后的第二次宫腔镜检查：前瞻性地收集了有关粘连严重程度和治疗后持续妊娠的数据。共纳入了 428 名患有阿什曼综合征的妇女，其中 4 名妇女（0.9%）发生了自发性子宫破裂。子宫破裂发生的时间各不相同，没有一名产妇处于临产状态，子宫破裂的发生与粘连的严重程度无关。子宫破裂均发生在宫底。一名产妇的子宫底曾发生过子宫壁穿孔。新生儿预后较差，两例新生儿宫内死亡，两例新生儿终身残疾。结论：患有阿瑟曼综合征的妇女很容易发生子宫破裂：结论：患有阿什曼综合征的妇女有子宫破裂的风险，这是一种具有严重后果的妊娠并发症，很难预测，也可能与子宫穿孔病史有关。临床医生应了解宫腔镜粘连分解术治疗妇女的这一风险，并考虑在治疗前对这些患者进行相应的咨询。

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引用次数: 0

Endoscopic Closure of Rectosigmoid Injury with OTS Clip After Laparoscopic Surgery for Extensive Endometriosis. 腹腔镜手术治疗广泛性子宫内膜异位症后使用 OTS 夹在内镜下闭合直肠乙状结肠损伤。

IF 3.5 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Journal of minimally invasive gynecology

Pub Date : 2024-11-05 DOI: 10.1016/j.jmig.2024.10.029

Sami Shihada, Michael Oelckers, Gaby Moawad, Rüdiger Klapdor

引用次数: 0

Wound Infiltration with Local Anesthetics Versus Transversus Abdominis Plane Block for Postoperative Pain Management in Gynecological Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. 妇科手术中伤口浸润局麻药与腹横肌平面阻滞治疗术后疼痛的比较：随机对照试验的系统回顾和元分析》。

IF 3.5 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Journal of minimally invasive gynecology

Pub Date : 2024-11-05 DOI: 10.1016/j.jmig.2024.10.030

Filippo Alberto Ferrari, Beatrice Crestani, Lorena Torroni, Matteo Pavone, Federico Ferrari, Nicolas Bourdel, Massimo Franchi, Stefano Uccella

Objective: Postoperative pain management significantly influences recovery speed, hospital stay duration, and healthcare costs. In light of inconsistencies in clinical trial outcomes, we conducted a systematic review and meta-analysis to assess the efficacy of the Transversus Abdominis Plane (TAP) block compared to local anesthetic wound infiltration (WI) for postoperative pain management in gynecological surgery.

Data sources: Systematic searches were conducted across PubMed/MEDLINE, ScienceDirect, the Cochrane Library, and Web of Science databases to identify all randomized controlled trials comparing TAP block and WI in adult patients undergoing gynecological surgical procedures. Additionally, the reference lists of the identified studies were manually reviewed. Only studies published in English were eligible for inclusion in the analysis.

Methods of study selection: The Population, Intervention, Comparison, and Outcome framework for the review included: (1) adult patients who underwent gynecological surgical procedures; (2) postoperative TAP block as the intervention; (3) comparison with local anesthetic WI; (4) primary outcome: postoperative pain at 1, 4, 12, and 24 hours; secondary outcomes: postoperative opioid consumption, opioid-related side effects, and patient satisfaction. STATA software, version 18 (Stata Corp, College Station, TX, USA), was used for the analysis.

Tabulation, integration, and results: A total of 213 papers were initially identified. Of these, 10 randomized controlled trials encompassing a total of 604 patients met the inclusion criteria. The meta-analysis studying minimally invasive surgery showed that TAP block was associated with lower pain scores at rest and 1, 4, 12, and 24 hours compared to the WI group. Furthermore, the TAP block resulted in a reduction in opioid consumption at 24 hours, although there was no significant difference in opioid-related adverse effects. Two studies presented data on patient-reported satisfaction, and a pooled analysis was not feasible due to heterogeneity.

Conclusion: TAP block seems to provide better postoperative pain control after laparoscopic gynecologic procedures and reduces opioid use compared to WI in gynecologic surgery.

目的：术后疼痛管理对恢复速度、住院时间和医疗成本有很大影响。鉴于临床试验结果的不一致性，我们进行了一项系统性回顾和荟萃分析，以评估腹横肌平面（TAP）阻滞与局麻药伤口浸润（WI）相比在妇科手术术后疼痛管理方面的疗效：我们在 PubMed/MEDLINE、ScienceDirect、Cochrane Library 和 Web of Science 数据库中进行了系统检索，以确定在接受妇科手术的成年患者中比较 TAP 阻滞和 WI 的所有随机对照试验 (RCT)。此外，还对已确定研究的参考文献目录进行了人工审核。只有用英语发表的研究才有资格纳入分析：综述的人群、干预、比较和结果（PICO）框架包括(1)接受妇科手术的成年患者；(2)以术后 TAP 阻滞为干预措施；(3)与局部麻醉药伤口浸润进行比较；(4)主要结果：术后 1、4、12 和 24 小时的疼痛；次要结果：术后阿片类药物消耗量、阿片类药物相关副作用和患者满意度。分析使用 STATA 软件 18 版（Stata Corp，College Station，Texas，USA）：最初共确定了 213 篇论文。制表、整合和结果：最初共找到 213 篇论文，其中有 10 篇 RCT 符合纳入标准，共涉及 604 名患者。荟萃分析表明，在微创手术中，与 WI 组相比，TAP 阻滞可降低静息和 1、4、12 和 24 小时时的疼痛评分。此外，TAP阻滞可减少 24 小时内阿片类药物的用量，但与阿片类药物相关的不良反应并无显著差异。有两项研究提供了患者报告的满意度数据，由于存在异质性，因此无法进行汇总分析：结论：与妇科手术中的WI相比，TAP阻滞似乎能更好地控制腹腔镜妇科手术后的疼痛，并减少阿片类药物的使用。

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引用次数: 0

Does Size Matter? Investigating the Association Between Endometrioma on Pre-Operative Imaging and AAGL Endometriosis Stage 大小重要吗？调查术前造影显示的子宫内膜异位症与 AAGL 子宫内膜异位症分期之间的关系

IF 3.5 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Journal of minimally invasive gynecology

Pub Date : 2024-11-01 DOI: 10.1016/j.jmig.2024.09.073

EE Spurlin , EC Bardawil , D Wang , CM Mulligan , K de Souza , W Ross

Study Objective

To investigate the association between the size of endometriomas on pre-operative imaging and the stage and extent of endometriosis based on laparoscopic findings according to the AAGL 2021 Endometriosis Classification.

Design

Retrospective cohort study.

Setting

High-volume academic gynecologic surgical practice.

Patients or Participants

Sixty-nine patients with endometriomas on pre-operative imaging undergoing surgical management of endometriosis from June 2022 to April 2024.

Interventions

Preoperative assessment of endometrioma size and laterality on ultrasound and/or MRI.

Measurements and Main Results

Sixty-nine patients met the inclusion criteria. The median of days elapsed from imaging date to the date of surgery was 81 [40, 136] days. The mean age of patients was 34±7.3 years. The majority of patients self-reported as Black (17.4%) or White (75.4%) and the mean BMI was 27.8±6.8 kg/m². The most commonly reported symptom was dysmenorrhea (95.7%) while dyschezia (37.7%) and infertility (20.3%) were less common. On pelvic exam, 39.1% had myofascial tenderness, 21.7% had uterosacral nodularity or thickening, and 5.8% had reduced uterine mobility.

Pre-operative imaging showed median endometrioma size of 49 [30, 62] mm on ultrasound (N=42) and 50 [23, 54] mm on MRI (N=27). Surgical AAGL endometriosis staging found that no patients had stage 1 disease while 79.7% had stage 4 disease. Patients who had endometriomas ≥ 40 mm often had higher surgical complexity as compared to those with smaller endometriomas, including more frequent cul-de-sac obliteration (71.4% vs 48.1%), rectovaginal septum disease (35.7% vs 18.5%), and appendiceal involvement (38.1% vs 11.1%).

Conclusion

In this sample, endometriomas on pre-operative imaging, regardless of size, were most frequently connected to stage III or IV endometriosis. For endometriomas ≥40 mm, a higher degree of surgical complexity was frequently encountered. Gynecologic surgeons operating on patients with endometriomas should be prepared to treat complex endometriosis. Understanding this relationship may aid clinicians considering referral to a gynecologic surgical specialists.

研究目的根据AAGL 2021年子宫内膜异位症分类，研究术前成像显示的子宫内膜异位症大小与腹腔镜检查结果显示的子宫内膜异位症分期和范围之间的关联。干预措施术前通过超声和/或磁共振成像评估子宫内膜异位症的大小和侧位.测量和主要结果69例患者符合纳入标准。从造影日期到手术日期的中位天数为 81 [40, 136] 天。患者的平均年龄为（34±7.3）岁。大多数患者自称是黑人（17.4%）或白人（75.4%），平均体重指数（BMI）为 27.8±6.8 kg/m2。最常报告的症状是痛经（95.7%），而月经失调（37.7%）和不孕（20.3%）较少见。在盆腔检查中，39.1%的患者有肌筋膜触痛，21.7%的患者有子宫骶骨结节或增厚，5.8%的患者子宫活动度降低。术前影像学检查显示，子宫内膜异位症的中位大小为：超声检查 49 [30, 62] mm（42 例），核磁共振成像检查 50 [23, 54] mm（27 例）。AAGL 子宫内膜异位症手术分期发现，没有患者属于 1 期疾病，79.7% 的患者属于 4 期疾病。与较小的子宫内膜异位症患者相比，子宫内膜异位症≥40 mm的患者通常手术复杂性更高，包括更常见的暗道闭塞（71.4% vs 48.1%）、直肠阴道隔疾病（35.7% vs 18.5%）和阑尾受累（38.1% vs 11.1%）。对于≥40 毫米的子宫内膜异位症，手术复杂程度更高。为子宫内膜异位症患者进行手术的妇科外科医生应做好治疗复杂子宫内膜异位症的准备。了解这种关系有助于临床医生考虑将患者转诊给妇科外科专家。

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引用次数: 0

Ureter Reimplantation for Deep Infiltrative Endometriosis 输尿管再植治疗深部浸润性子宫内膜异位症

IF 3.5 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Journal of minimally invasive gynecology

Pub Date : 2024-11-01 DOI: 10.1016/j.jmig.2024.09.137

MK Cantave , A Kosmacki , E Vargo , S Biest , E Kim , W Ross

Study Objective

The objective of this video is to demonstrate the surgical technique for ureter re-implantation involving a deep infiltrating endometriotic lesion impinging on the bladder and causing left ureteral obstruction.

Design

Surgical video recording of steps to perform left ureter re-implantation after excision of deep infiltrating endometriotic lesion.

Setting

Operating Room.

Patients or Participants

This is a 37 year old G3P2 female with history of severe dysmenorrhea who presents with left flank pain and found to have moderately severe left hydroureteronephrosis secondary to endometriotic nodule compressing the left ureter.

Interventions

Robotic assisted total laparoscopic hysterectomy with bilateral salpingo-ophrectomy and left ureteral re-implantation.

Measurements and Main Results

There are a variety of techniques to repair and reimplant the ureter involved in extrinsic ureteral endometriosis. Surgical management of ureteral re-implantation in extrinsic ureteral endometriosis varies depending on location and depth of lesion. Complete excision of endometriotic lesion in this patient required intentional iatrogenic ureteral injury with reimplantation. This video will demonstrate ureter re-implantation with creation of ureteroneocystotomy and bladder hitch.

Conclusion

Ureteral re-implantation with ureteroneocystostomy and bladder hitch is an effective surgical management of deep infiltrating extrinsic ureteral endometriosis.

研究目的本视频旨在展示输尿管再植术的手术技巧，该手术涉及深部浸润性子宫内膜异位症病灶对膀胱的冲击并导致左侧输尿管梗阻。设计手术视频记录了切除深部浸润性子宫内膜异位症病灶后进行左侧输尿管再植术的步骤。患者或参与者这是一名 37 岁的 G3P2 女性，有严重痛经病史，因左侧腹痛而就诊，发现有中度严重的左侧输尿管积水，继发于压迫左侧输尿管的子宫内膜异位结节。干预措施机器人辅助全腹腔镜子宫切除术，双侧输卵管切除术和左侧输尿管再植术。测量和主要结果目前有多种技术用于修复和再植输尿管外子宫内膜异位症所涉及的输尿管。输尿管外子宫内膜异位症输尿管再植的手术治疗方法因病变的位置和深度而异。该患者的子宫内膜异位症病灶完全切除后，需要进行有意的输尿管损伤再植。本视频将演示输尿管再植，同时进行输尿管膀胱造口术和膀胱搭桥术。结论输尿管再植，同时进行输尿管膀胱造口术和膀胱搭桥术是治疗深部浸润性输尿管外子宫内膜异位症的有效手术方法。

{"title":"Ureter Reimplantation for Deep Infiltrative Endometriosis","authors":"MK Cantave , A Kosmacki , E Vargo , S Biest , E Kim , W Ross","doi":"10.1016/j.jmig.2024.09.137","DOIUrl":"10.1016/j.jmig.2024.09.137","url":null,"abstract":"<div><h3>Study Objective</h3><div>The objective of this video is to demonstrate the surgical technique for ureter re-implantation involving a deep infiltrating endometriotic lesion impinging on the bladder and causing left ureteral obstruction.</div></div><div><h3>Design</h3><div>Surgical video recording of steps to perform left ureter re-implantation after excision of deep infiltrating endometriotic lesion.</div></div><div><h3>Setting</h3><div>Operating Room.</div></div><div><h3>Patients or Participants</h3><div>This is a 37 year old G3P2 female with history of severe dysmenorrhea who presents with left flank pain and found to have moderately severe left hydroureteronephrosis secondary to endometriotic nodule compressing the left ureter.</div></div><div><h3>Interventions</h3><div>Robotic assisted total laparoscopic hysterectomy with bilateral salpingo-ophrectomy and left ureteral re-implantation.</div></div><div><h3>Measurements and Main Results</h3><div>There are a variety of techniques to repair and reimplant the ureter involved in extrinsic ureteral endometriosis. Surgical management of ureteral re-implantation in extrinsic ureteral endometriosis varies depending on location and depth of lesion. Complete excision of endometriotic lesion in this patient required intentional iatrogenic ureteral injury with reimplantation. This video will demonstrate ureter re-implantation with creation of ureteroneocystotomy and bladder hitch.</div></div><div><h3>Conclusion</h3><div>Ureteral re-implantation with ureteroneocystostomy and bladder hitch is an effective surgical management of deep infiltrating extrinsic ureteral endometriosis.</div></div>","PeriodicalId":16397,"journal":{"name":"Journal of minimally invasive gynecology","volume":"31 11","pages":"Page S35"},"PeriodicalIF":3.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142658147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Case of an Accessory Cavitated Uterine Malformation (ACUM) 附属腔隙子宫畸形（ACUM）病例

IF 3.5 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Journal of minimally invasive gynecology

Pub Date : 2024-11-01 DOI: 10.1016/j.jmig.2024.09.116

M Ramaswamy , Y Youssef , O Azar , P Bral

Study Objective

The purpose of this video is to present a case of an Accessory Cavitated Uterine Malformation.

Design

Video footage illustrating the surgical removal of a uterine accessory cavity.

Setting

Tertiary referral center.

Patients or Participants

A 19 yo gravida 0 who presented with pelvic pain for several years, worse with menses. A pre-operative pelvic ultrasound suggested a degenerating myoma measuring 2.8cm as the cause of her pelvic pain. Pathology confirmed presence of endometrial glands within muscle cells.

Interventions

Robotic assisted laparoscopic removal of accessory cavity. This involved injecting diluted vasopressin to the base of the accessory mass for vasoconstriction prior to incision and dissection, and suture of defect.

Measurements and Main Results

Resolution of pelvic pain in the patient 2 months post-operative

Conclusion

Accessory Cavitated Uterine Malformation is an unclassified Mullerian anomaly of unknown true incidence. Surgical Excision can provide resolution of symptoms of pelvic pain.

研究目的本视频旨在介绍一例子宫附件空腔畸形病例。设计视频展示了子宫附件空腔的手术切除过程。设置三级转诊中心。患者或参与者一名 19 岁的 0 型孕妇，数年来一直感到盆腔疼痛，经期时疼痛加剧。术前盆腔超声检查显示，她的盆腔疼痛是由一个2.8厘米的退化肌瘤引起的。病理证实，在肌细胞内存在子宫内膜腺体。干预措施机器人辅助腹腔镜切除附件腔。测量和主要结果患者术后 2 个月盆腔疼痛缓解结论附件空腔子宫畸形是一种未分类的穆勒氏畸形，真实发病率未知。手术切除可缓解盆腔疼痛症状。

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引用次数: 0

International Societies 国际社团

IF 3.5 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Journal of minimally invasive gynecology

Pub Date : 2024-11-01 DOI: 10.1016/S1553-4650(24)00780-5

引用次数: 0

Bladder Endometriosis Fluorescence-Guided Surgery - A Case Report 膀胱子宫内膜异位症荧光引导手术--病例报告

IF 3.5 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Journal of minimally invasive gynecology

Pub Date : 2024-11-01 DOI: 10.1016/j.jmig.2024.09.136

Teixeira BA Castelo Branco, K Mori, A Nicola, F Ohara, P Ayroza, H Salomão

Study Objective

Describe a complex case of a patient with a large bladder endometriosis nodule with surgical excision guided by indocyanine green (ICG).

Design

Narrated surgical video discussing the surgical technique to excise a large bladder endometriosis nodule using indocyanine green to guide the dissection. This video highlights indocyanine green as a useful tool in a complex case of endometriosis as well as, identification of important anatomical landmarks for this type of procedure

Setting

Tertiary academic center. The patient was positioned in semi-gynecological position for the procedure. A 10 mm port was placed on the umbilicus, and 3 auxiliary ports were placed following the triangulation technique.

Patients or Participants

32-years-old woman with dismenorrhea for 5 years, and occasional dysuria, with no improvemnt with LNG-IUD. On physical examination, she had a 2-cm palpable nodule on the retrocervical area. Her transvaginal ultrassound showed, bladder nodule with infiltration into the submucosa, as well as her RMI showed a perivesical peritoneal lesion with infiltration of the detrusor muscle, and anterior myometrium. The urodynamic study demonstrated reduced bladder complacency.

Interventions

The patient underwent cystoscopy with ureteral catheterization with indocynine green injection. A laparoscopy was performed for the excision of the endometriosis with removal of the bladder nodule after vesico-uterine space dissection, guided by ICG. Adjacent myometrium was removed to decrease the risks of recurrence. The bladder was then sutured.

Measurements and Main Results

The procedure was completed without any complications. Endometriosis were confirmed through the pathology report. The patient reported a complete improvement of her symptoms after 6-month of follow up.

Conclusion

The technique performed in the video demonstrates the benefit of using ICG, identifying anatomical landmarks and limits, ensuring complete resection of bladder endometriosis, as well as reducing postoperative complications.

研究目的描述一例复杂的膀胱子宫内膜异位症大结节患者在吲哚菁绿（ICG）引导下进行手术切除的病例。设计叙述性手术视频，讨论使用吲哚菁绿引导解剖切除膀胱子宫内膜异位症大结节的手术技巧。该视频重点介绍了吲哚菁绿作为子宫内膜异位症复杂病例中的有用工具，以及识别此类手术的重要解剖标志。患者取半妇科体位进行手术。患者或参与者 32 岁女性，痛经 5 年，偶尔排尿困难，使用 LNG-IUD 无改善。体格检查时，她的宫颈后区有一个 2 厘米的可触及结节。经阴道超声检查显示，膀胱结节浸润到粘膜下层，RMI显示腹膜周围病变，并浸润到排尿肌和子宫前部。患者接受了膀胱镜检查和输尿管导管检查，并注射了吲哚炔宁绿。患者接受了膀胱镜检查和输尿管导管检查，并注射了吲哚炔诺酮绿，在 ICG 的引导下进行了腹腔镜手术，切除了子宫内膜异位症，并在膀胱子宫间隙剥离后切除了膀胱结节。为降低复发风险，还切除了邻近的子宫肌层。测量和主要结果手术顺利完成，未出现任何并发症。病理报告证实了子宫内膜异位症。结论视频中的技术展示了使用 ICG 的益处，可识别解剖标志和界限，确保完整切除膀胱子宫内膜异位症，并减少术后并发症。

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引用次数: 0

Treatment of Severe and Moderate Intrauterine Adhesions: Results of PREG2 International RCT on the Effectiveness of Womed Leaf Barrier Film 治疗重度和中度宫内粘连：关于沃麦德叶片屏障膜疗效的 PREG2 国际临床试验结果

IF 3.5 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Journal of minimally invasive gynecology

Pub Date : 2024-11-01 DOI: 10.1016/j.jmig.2024.09.095

H Fernandez , L Miquel , J Sroussi , S Weyers , M Munmany , X Luo , P Kovar , Y Wang , A Sardo Di Spiezio , A Surbonne , V Delporte , E Moratalla , M Sauvan , G Perrini , L Sui , M Mara

Study Objective

Recurrence rate after hysteroscopic adhesiolysis can be as high as 60%. This RCT aimed to assess the effectiveness of a new intrauterine mechanical barrier film in the management of IUA.

Design

PREG2 is a double-blind randomized, controlled, stratified study.

Setting

16 sites in Europe and China.

Patients or Participants

Patients scheduled for hysteroscopic adhesiolysis because of symptomatic severe or moderate adhesions (AFS score ≥ 5).

Interventions

Following adhesiolysis, patients were randomized to either have a Womed Leaf film inserted or not. Womed Leaf (Womed SAS, France) is a degradable polymer film that expands to fill the entire cavity and acts as a mechanical barrier between the uterine walls. After about a week, it degrades and is discharged naturally. Hormonal treatment was authorized in both groups. Patients were scheduled for second-look hysteroscopy (SLH) after 4 to 8 weeks.

Measurements and Main Results

The effectiveness endpoints were: Change in AFS score between baseline and SLH, responder rate (i.e. patients who improved of at least two clinical categories, e.g. from severe to mild or from moderate to no IUA) and absence of IUA at SLH. The patient and the SLH evaluator were blind. 160 women were randomized. The reduction in AFS score at SLH was significantly higher in the intervention compared to the control group (5.2 ± 2.8 vs. 4.2 ± 3.2; p=0.0153). The responder rate was significantly higher in the intervention group (51% vs 29% OR 2.7 [1.4–5.5]; p=0.0052). The absence of adhesions at SLH was significantly higher in the intervention group (41% vs 24% OR 2.44 [CI 1.161 - 5.116]; p=0.0189). None of the reported adverse events were serious or considered related to the device.

Conclusion

This large RCT of patients with severe or moderate IUA demonstrated the effectiveness of Womed Leaf. It is the first adhesion barrier to show any clinically meaningful improvement in this challenging indication.

研究目的宫腔镜粘连分解术后的复发率可高达60%。这项研究旨在评估一种新型宫腔内机械屏障膜在治疗 IUA 方面的有效性。设计PREG2 是一项双盲随机对照分层研究。患者或参与者因无症状的重度或中度粘连（AFS 评分≥ 5 分）而计划接受宫腔镜粘连溶解术的患者。干预措施粘连溶解术后，患者被随机分配是否植入 Womed Leaf 膜。Womed Leaf（Womed SAS，法国）是一种可降解的聚合物薄膜，可膨胀以填充整个宫腔，在子宫壁之间起到机械屏障的作用。大约一周后，它就会降解并自然排出。两组患者都接受了激素治疗。患者将在 4 至 8 周后接受宫腔镜二次检查（SLH）：疗效终点为：基线与 SLH 之间 AFS 评分的变化、应答率（即至少两个临床类别得到改善的患者，如从重度到轻度或从中度到无 IUA）以及 SLH 时无 IUA。患者和 SLH 评估人员均为盲人。160 名妇女被随机选中。与对照组相比，干预组在SLH时的AFS评分降低幅度明显更高（5.2 ± 2.8 vs. 4.2 ± 3.2；P=0.0153）。干预组的应答率明显更高（51% vs 29% OR 2.7 [1.4-5.5]; p=0.0052）。干预组腹腔镜下无粘连率明显更高（41% vs 24% OR 2.44 [CI 1.161 - 5.116]；P=0.0189）。结论这项针对重度或中度 IUA 患者的大型 RCT 证明了 Womed Leaf 的有效性。它是首个在这一具有挑战性的适应症中显示出有临床意义的改善的粘连屏障。

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引用次数: 0