[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583125":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":65,"collaborators":69,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":20,"enrollmentInfo":84,"targetDuration":20,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":20,"overallStatus":95,"whyStopped":20,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Institute for Clinical and Experimental Medicine","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"POEM arm","EXPERIMENTAL","Patients, who will undergo peroral endoscopic myotomy for postfundoplication dysphagia",[13],"Procedure: Per Oral Endoscopic Myotomy (POEM)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Per Oral Endoscopic Myotomy (POEM)","All procedures will be performed by an experienced endoscopist, with a sufficient experience in \"third space\" endoscopy (at least 100 POEMs) under general anesthesia (internal preoperative examination is necessary) with a high-definition endoscope, fitted with a plastic distal attachment. Before the procedure, the patients will be administered intravenous antibiotics. Exclusively CO2 will be used for insufflation. POEM will be performed in a similar way as in patients with achalasia - the procedure consists of 4 steps: (1) mucosal incision and tunnel entry, (2) submucosal tunneling, (3) myotomy, and (4) closure of the mucosal entry with endoscopic clips or other closure devices. Perioperative protocol might differ according the usual way of performing POEM in a given center.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Jan Martínek, prof., MD","CONTACT","+420 723 708 839","jan.martinek@fnusa.cz",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Martin Vašátko, MD","+420 739 476 451","martin.vasatko@fnusa.cz",[32,46],{"facility":33,"status":20,"city":34,"state":20,"zip":35,"country":36,"countryCode":20,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"St. Anne's University Hospital Brno, Czech Republic","Brno","60200","Czechia",{"type":38,"coordinates":39},"Point",[40,41],16.60796,49.19522,{"lat":41,"lon":40},[44,45],{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"facility":47,"status":20,"city":48,"state":20,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"University Hospital Trnava","Trnava","91701","Slovakia","SK",{"type":38,"coordinates":53},[54,55],17.58603,48.37773,{"lat":55,"lon":54},[58,62],{"name":59,"role":24,"phone":60,"phoneExt":20,"email":61},"Rastislav Husťak, MD","+421 33\u002F593 81 11","rhustak@gmail.com",{"name":63,"role":24,"phone":60,"phoneExt":20,"email":64},"Ján Ušák, MD","jan.usak@gmail.com",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":33,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Prof. Jan Martinek, MD, PhD, AGAF","Head of Gastroenterology and hepatology department",[70,72],{"name":47,"class":71},"NETWORK",{"name":33,"class":73},"OTHER","100583125","per-oral-endoscopic-myotomy-poem-in-patients-with-postfundplication-dysphagia-100583125",false,"NCT06872255","Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia","A Prospective Pilot Trial of Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia (VADYSMA Trial)","VADYSMA","Inclusion Criteria:\n\n1. Patients after laparoscopic fundoplication procedure by Nissen (total, 360°), Dor (anterior, 180°) or Toupet (posterior, 270°) for gastroesophageal reflux disease no later than 10 years before enrolment.\n2. Refractory (\\> 6 months) and severe dysphagia after fundoplication procedure defined as an Eckardt score ≥3 and Mellow - Pinkas score ≥2 at baseline.\n3. X-ray (contrasted radiographic examination of the esophagus) characterized by both: a.) tapered narrowing of the distal esophagus and GEJ; b.) partial\u002Ftotal stagnation of the contrast solution above the GEJ\n4. Endoluminal planimetry: EGJ-DI \\\u003C 3 mm2\u002FmmHg (with 40ml)\n5. Age above 18 years\n6. Signed informed consent form\n\nExclusion Criteria:\n\n1. No previous attempt with at least one prokinetic drug\n2. Previous esophageal myotomy (open, laparoscopic or endoscopic)\n3. Primary esophageal motility disorder (achalasia etc.)\n4. Active erosive esophagitis\n5. Active peptic ulcer disease\n6. Esophageal stricture (peptic, malignant, other)\n7. Partial or complete supradiaphragmatic migration of the wrap and\u002For stomach (Hinder Type III - IV), Large hiatal hernia more than 5 cm\n8. Known eosinophilic esophagitis\n9. Severe coagulopathy\n10. Esophageal or gastric varices\n11. Advanced liver cirrhosis (Child B or Child C)\n12. Pregnancy or puerperium\n13. Malignant or pre-malignant esophageal diseases (dysplasia): patients with a history of such disease after its cure are eligible for enrolment\n14. Any other condition, which in the opinion of the investigator would interfere with study requirements\n15. Known gastroparesis","ALL","18 Years",{"count":85,"type":86},30,"ESTIMATED","INTERVENTIONAL",[89],"NA","Laparoscopic fundoplication represents the standard antireflux procedure, when conservative measures fail. However, any type of fundoplication may be accompanied by adverse events. Postfundoplication dysphagia (PFD) may hamper results of anti-reflux surgery. Endoscopic pneumatic dilation has been considered as the first line treatment option for persistent PFD. However, studies have not confirmed its effectiveness in this indication. Peroral endoscopic myotomy (POEM) became a standard treatment for the management of esophageal achalasia and moreover has also been assessed in a small cohort of patients with refractory PFD and some patients achieved significant treatment success. We plan to perform a prospective international cohort multicenter study assessing the efficacy of POEM in patients with persistent and severe PFD.",[92,93,94],"Dysphagia","Dysphagia, Esophageal","Healthy","NOT_YET_RECRUITING","2025-03-06",{"date":98,"type":99},"2025-03-12","ACTUAL",{"date":101,"type":86},"2025-04-01",{"date":103,"type":86},"2027-06-01",{"name":5,"class":6},2]