Zdenka Lisa, Adela Richtarova, Kristyna Hlinecka, Barbora Boudova, David Kuzel, Michael Fanta, Michal Mara
{"title":"4DryField 与 hyalobarrier 凝胶在预防宫腔内粘连复发方面的对比--一项试点研究。","authors":"Zdenka Lisa, Adela Richtarova, Kristyna Hlinecka, Barbora Boudova, David Kuzel, Michael Fanta, Michal Mara","doi":"10.1080/13645706.2024.2351829","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>This was a single-center pilot study that sought to describe an innovative use of 4DryField® PH (premix) for preventing the recurrence of intrauterine adhesions (IUAs) after hysteroscopic adhesiolysis in patients with Asherman's syndrome (AS).</p><p><strong>Material and methods: </strong>Twenty-three patients with AS were enrolled and 20 were randomized (1:1 ratio) to intrauterine application of 4DryField® PH (<i>n</i> = 10) or Hyalobarrier<sup>®</sup> gel (<i>n</i> = 10) in a single-blind manner. We evaluated IUAs (American Fertility Society [AFS] score) during initial hysteroscopy and second-look hysteroscopy one month later. Patients completed a follow-up symptoms questionnaire three and reproductive outcomes questionnaire six months later.</p><p><strong>Results: </strong>The demographic and clinical characteristics, as well as severity of IUAs, were comparable in both groups. The mean initial AFS score was 9 and 8.5 in the 4DryField<sup>®</sup> PH and Hyalobarrier<sup>®</sup> gel groups, respectively (<i>p</i> = .476). There were no between-group differences in AFS progress (5.9 vs. 5.6, <i>p</i> = .675), need for secondary adhesiolysis (7 vs. 7 patients, <i>p</i> = 1), and the follow-up outcomes.</p><p><strong>Conclusion: </strong>4DryField<sup>®</sup> PH could be a promising antiadhesive agent for preventing the recurrence of IUAs, showing similar effectiveness and safety to Hyalobarrier<sup>®</sup> gel. Our findings warrant prospective validation in a larger clinical trial.</p><p><strong>Clinical trial registry number: </strong>ISRCTN15630617.</p>","PeriodicalId":18537,"journal":{"name":"Minimally Invasive Therapy & Allied Technologies","volume":" ","pages":"1-7"},"PeriodicalIF":1.7000,"publicationDate":"2024-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"4DryField vs. hyalobarrier gel for preventing the recurrence of intrauterine adhesions - a pilot study.\",\"authors\":\"Zdenka Lisa, Adela Richtarova, Kristyna Hlinecka, Barbora Boudova, David Kuzel, Michael Fanta, Michal Mara\",\"doi\":\"10.1080/13645706.2024.2351829\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>This was a single-center pilot study that sought to describe an innovative use of 4DryField® PH (premix) for preventing the recurrence of intrauterine adhesions (IUAs) after hysteroscopic adhesiolysis in patients with Asherman's syndrome (AS).</p><p><strong>Material and methods: </strong>Twenty-three patients with AS were enrolled and 20 were randomized (1:1 ratio) to intrauterine application of 4DryField® PH (<i>n</i> = 10) or Hyalobarrier<sup>®</sup> gel (<i>n</i> = 10) in a single-blind manner. We evaluated IUAs (American Fertility Society [AFS] score) during initial hysteroscopy and second-look hysteroscopy one month later. Patients completed a follow-up symptoms questionnaire three and reproductive outcomes questionnaire six months later.</p><p><strong>Results: </strong>The demographic and clinical characteristics, as well as severity of IUAs, were comparable in both groups. The mean initial AFS score was 9 and 8.5 in the 4DryField<sup>®</sup> PH and Hyalobarrier<sup>®</sup> gel groups, respectively (<i>p</i> = .476). There were no between-group differences in AFS progress (5.9 vs. 5.6, <i>p</i> = .675), need for secondary adhesiolysis (7 vs. 7 patients, <i>p</i> = 1), and the follow-up outcomes.</p><p><strong>Conclusion: </strong>4DryField<sup>®</sup> PH could be a promising antiadhesive agent for preventing the recurrence of IUAs, showing similar effectiveness and safety to Hyalobarrier<sup>®</sup> gel. Our findings warrant prospective validation in a larger clinical trial.</p><p><strong>Clinical trial registry number: </strong>ISRCTN15630617.</p>\",\"PeriodicalId\":18537,\"journal\":{\"name\":\"Minimally Invasive Therapy & Allied Technologies\",\"volume\":\" \",\"pages\":\"1-7\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2024-05-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Minimally Invasive Therapy & Allied Technologies\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/13645706.2024.2351829\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Minimally Invasive Therapy & Allied Technologies","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/13645706.2024.2351829","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}
4DryField vs. hyalobarrier gel for preventing the recurrence of intrauterine adhesions - a pilot study.
Introduction: This was a single-center pilot study that sought to describe an innovative use of 4DryField® PH (premix) for preventing the recurrence of intrauterine adhesions (IUAs) after hysteroscopic adhesiolysis in patients with Asherman's syndrome (AS).
Material and methods: Twenty-three patients with AS were enrolled and 20 were randomized (1:1 ratio) to intrauterine application of 4DryField® PH (n = 10) or Hyalobarrier® gel (n = 10) in a single-blind manner. We evaluated IUAs (American Fertility Society [AFS] score) during initial hysteroscopy and second-look hysteroscopy one month later. Patients completed a follow-up symptoms questionnaire three and reproductive outcomes questionnaire six months later.
Results: The demographic and clinical characteristics, as well as severity of IUAs, were comparable in both groups. The mean initial AFS score was 9 and 8.5 in the 4DryField® PH and Hyalobarrier® gel groups, respectively (p = .476). There were no between-group differences in AFS progress (5.9 vs. 5.6, p = .675), need for secondary adhesiolysis (7 vs. 7 patients, p = 1), and the follow-up outcomes.
Conclusion: 4DryField® PH could be a promising antiadhesive agent for preventing the recurrence of IUAs, showing similar effectiveness and safety to Hyalobarrier® gel. Our findings warrant prospective validation in a larger clinical trial.
期刊介绍：
Minimally Invasive Therapy and Allied Technologies (MITAT) is an international forum for endoscopic surgeons, interventional radiologists and industrial instrument manufacturers. It is the official journal of the Society for Medical Innovation and Technology (SMIT) whose membership includes representatives from a broad spectrum of medical specialities, instrument manufacturing and research. The journal brings the latest developments and innovations in minimally invasive therapy to its readers. What makes Minimally Invasive Therapy and Allied Technologies unique is that we publish one or two special issues each year, which are devoted to a specific theme. Key topics covered by the journal include: interventional radiology, endoscopic surgery, imaging technology, manipulators and robotics for surgery and education and training for MIS.
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