[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"paraesophageal-hernia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:paraesophageal-hernia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,78,98,119,143,166,189,213],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641615","antireflux-surgery-without-preoperative-esophageal-manometry-100641615",false,"NCT07659080","Antireflux Surgery Without Preoperative Esophageal Manometry","Laparoscopic Toupet Fundoplication With or Without Preoperative Esophageal Manometry in Patients With GERD and Hiatal Hernia","NOMA","Inclusion Criteria\n\n1. Age ≥ 18 years\n2. Documented GERD and\u002For hiatal hernia (Type I, II, or small Type III) confirmed on EGD and\u002For imaging (i.e. CT scan or upper GI study) within 12 months\n3. Presence of at least one guideline-based indication for antireflux surgery:\n\n   1. Typical GERD symptoms (heartburn and\u002For regurgitation) refractory to or recurrent after adequate PPI therapy\n   2. PPI-dependent GERD with patient preference for surgical management\n   3. Extra-esophageal GERD symptoms (chronic cough, laryngitis, asthma) with pathologic reflux confirmed on ambulatory pH study\n   4. Symptomatic Type II\u002FIII paraesophageal hernia (postprandial pain, early satiety, dysphagia to solids)\n   5. Objective documentation of pathologic esophageal acid exposure on ambulatory reflux monitoring (24-hour pH-impedance or 48-hour Bravo pH capsule) confirming GERD diagnosis, performed within 12 months of enrollment\n4. Mellow-Pinkas dysphagia score = 0 at baseline (no overt dysphagia)\n5. Eckardt score \\\u003C 1 (achalasia screening)\n6. Ability to provide informed consent and comply with 12-month follow-up.\n\nExclusion Criteria:\n\n1. Overt dysphagia (Mellow-Pinkas ≥ 1 or Eckardt ≥ 1)\n2. Prior esophageal or gastric surgery\n3. Known or clinically suspected achalasia or primary motility disorder\n4. Endoscopic stricture, mass, or luminal obstruction\n5. Giant paraesophageal hernia (Type IV, or Type III with \\>50% of stomach herniated intrathoracically)\n6. Connective tissue disease with esophageal involvement (e.g., scleroderma\u002FCREST)\n7. Active esophageal or gastric malignancy\n8. Pregnancy\n9. BMI \\> 40 kg\u002Fm² (patients with severe obesity who would be candidates for bariatric surgery should be referred for metabolic\u002Fbariatric evaluation, as per the multi-society GERD guideline recommending weight-loss surgery consideration in this population)\n10. Participation in another interventional trial within 30 days\n11. Prior esophageal manometry within 12 months demonstrating a major motility disorder (achalasia, absent contractility, distal esophageal spasm, hypercontractile esophagus); such patients should be managed per standard motility disorder pathways and are not candidates for this trial.","ALL","18 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if people can safely skip a test called esophageal manometry before surgery for acid reflux (gastroesophageal reflux disease, or GERD) or a hiatal hernia. Manometry measures the muscles of the food pipe using a thin tube passed through the nose. The test can be uncomfortable and can delay surgery. The main questions this study aims to answer are whether people can skip manometry and still have good swallowing one year after surgery, and whether skipping the test lowers discomfort, shortens the wait for surgery, and lowers cost. To answer this, researchers will compare two groups. One group will have surgery without manometry. The other group will have manometry first, the way it is usually done. Everyone will get the same operation, a partial wrap called a Toupet fundoplication, so the study tests the value of the test and not the surgery. Participants will be placed by chance into one of the two groups, have the same standard operation, and fill out short questionnaires about their swallowing before surgery and again at 3, 6, and 12 months after surgery. Researchers want to find out if skipping manometry works just as well as the usual approach for people who do not have trouble swallowing before surgery.",[27,28,29,30,31],"GERD","Hiatal Hernia","Heartburn","Paraesophageal Hernia","Gastroesophageal Reflux",[27,33,34,35,30],"hiatal hernia","fundoplication","Gastroesophageal Reflux Disease","NOT_YET_RECRUITING","2026-06-16",{"date":39,"type":40},"2026-06-22","ACTUAL",{"date":42,"type":21},"2026-10-01",{"date":44,"type":21},"2028-04-30",{"name":46,"class":47},"McMaster University","OTHER",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100530958","ovitex-in-paraesophageal-and-large-hiatal-hernia-repair-100530958","NCT06193551","Ovitex in Paraesophageal and Large Hiatal Hernia Repair","Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)","OviPHeR","Inclusion Criteria:\n\n* 18-85 year old with PEH and appropriate surgical indication for repair\n\nExclusion Criteria:\n\n* Under 22 years of age.\n* In need of an emergency procedure.\n* Currently being treated with another investigational drug or device.\n* Have had prior gastric or esophageal surgery.\n* Have had any previous intervention for GERD.\n* Are suspected or confirmed to have esophageal or gastric cancer.\n* Have a Body Mass Index (BMI) greater than 45.\n* Cannot understand trial requirements or are unable to comply with follow-up schedule.\n* Are pregnant, nursing, or plan to become pregnant.\n* Have a mental health disorder that would interfere with your ability to follow study instructions.\n* Have suspected or known allergies to Ovitex\n* Have an illness that may cause you to be unable to meet the protocol requirements or is associated with shortened life expectancy.","85 Years",{"count":59,"type":21},100,[24],"The purpose of the study is to evaluate the success of hiatal hernia repairs in patients with large (\\>5cm) or paraesophageal hernias when Ovitex LPR mesh used during the repair.",[30,63],"Large Hiatal Hernia",[65,66,33],"paraesophageal hiatal hernia","paraesphageal hernia","RECRUITING","2026-02-05",{"date":70,"type":40},"2026-02-09",{"date":72,"type":40},"2024-02-19",{"date":74,"type":21},"2030-06",{"name":76,"class":47},"Foregut Research Foundation",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":77},"100558435","posterior-rectus-sheath-hiatal-augmentation-in-paraesophageal-hernia-repair-100558435","NCT06551077","Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair","Prospective Trial of Posterior Rectus Sheath Hiatal Augmentation (PORSHA) in Paraesophageal Hernia Repair","Inclusion Criteria:\n\n* All patients undergoing PoRSHA. PoRSHA will be offered to all patients with PEH defects measuring greater than 4 cm.\n\nExclusion Criteria:\n\n* Patients that did not have PoRSHA.\n* Patients requiring therapeutic anticoagulation perioperatively or those with bleeding disorders, considering the added risk of bleeding at the donor site with exposed rectus muscle.",{"count":59,"type":21},"OBSERVATIONAL","This study will be a prospective observation study of the use of PoRSHA for repair in patients with challenging paraesophageal hernias.\n\nOne of the most challenging problems facing foregut surgeons is the large and complex paraesophageal hernia (PEH) repair in the older patient. The investigator has demonstrated good outcomes and durability with the initial use of a novel permanent autologous vascularized biologic fascial flap to reconstruct the diaphragmatic hiatus following standard hiatal hernia repair in selected patients. This technique is called a posterior rectus sheath flap hiatal augmentation or PoRSHA, which is performed to enhance the hiatal repair for large (type III and IV) and recurrent PEH. The investigator believes by using the patient's autologous vascularized and peritonealized fascia at the hiatal defect, PoRSHA could increase the strength and restore the hiatal complex properties in ways that synthetic mesh, or a primary repair cannot.\n\nThe hypothesis is that PoRSHA is a unique technique that has the potential to supplant current approaches to primary hiatal closure in select cases. By augmenting the hiatal closure with a vascularized fascial sheath, PoRSHA provides the tensile strength needed for the attenuated defects in large and complex PEHs.",[30],"2026-01-29",{"date":91,"type":40},"2026-02-02",{"date":93,"type":40},"2024-05-15",{"date":95,"type":21},"2029-05",{"name":97,"class":47},"University of Chicago",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":77},"100514148","mesh-vs-pledgets-for-repair-of-paraesophageal-hernia-100514148","NCT05974722","Mesh Vs Pledgets for Repair of Paraesophageal Hernia","A Randomized, Blinded, Parallel-group Trial Evaluating Mesh Versus Pledgeted Sutures in Paraesophageal Hernia Recurrence","Inclusion Criteria:\n\n* 18 years of age or older\n* Willing and able to provide informed consent\n* Willing and able to participate in long-term follow up including study visits and surveys\n* Type II, III, or IV hiatal hernia \\> 5 cm, confirmed via upper GI studies, CT, or MRI 5 cm or greater hernia confirmed intraoperatively\n\nExclusion Criteria:\n\n* Pregnancy\n* BMI \\>45\n* Allergy to any components of mesh\n* Patients undergoing PEHR with a concurrent bariatric procedure or other procedure to reduce stomach volume (sleeve gastrectomy, roux-en-y gastric bypass, duodenal switch, single-anastomosis gastric bypass, and partial or total gastrectomy)\n* Patients who have undergone previous hiatal hernia repair",{"count":106,"type":21},164,[24],"The goal of this clinical trial is to compare whether the use of Ovitex mesh provides superior reduction in 2-year recurrence compared to pledgeted suture closure (no mesh) for patients undergoing paraesophageal hernia repair at the Cleveland Clinic. The main questions it aims to answer are:\n\n* Determine whether there is a difference in 2-year rates of radiographic recurrence with Ovitex versus pledgeted sutures in paraesophageal hernia repair.\n* Assess patient quality of life (QOL) after paraesophageal hernia repair with pledgets and mesh. A two-tailed research hypothesis will be used to determine whether there are differences between the two arms",[30,27],"2025-10-02",{"date":112,"type":40},"2025-10-07",{"date":114,"type":40},"2023-09-11",{"date":116,"type":21},"2028-12",{"name":118,"class":47},"David Krpata",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":125,"enrollmentInfo":126,"targetDuration":128,"studyType":86,"phases":4,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":77},"100608135","effect-of-hernia-sac-excision-on-crural-tension-in-paraesophageal-hernia-repair-100608135","NCT07197619","Effect of Hernia Sac Excision on Crural Tension in Paraesophageal Hernia Repair","Inclusion Criteria:\n\n* All patients age 18-80 undergoing elective or emergent paraesophageal hernia repair for symptomatic paraesophageal hernia will be eligible for enrollment into the study.\n\nExclusion Criteria:\n\n* Patients with previous history of esophageal, gastric, diaphragmatic, or anti-reflux surgery will be excluded.","80 Years",{"count":127,"type":21},42,"30 Days","Paraesophageal hernia can cause significant clinical symptoms, including reflux, chest pain, nausea, regurgitation, and even life threatening conditions such as bowel obstruction, and gastric volvulus. Repair of a paraesophageal hernia is associated with significant recurrence rate, with primary repair often in excess of 50%. Hernia recurrence and revisional surgery significantly increase the likelihood of complications and decreased quality of life.",[30],[132,133],"Paraesophageal","Hernia","2025-09-22",{"date":136,"type":40},"2025-09-29",{"date":138,"type":40},"2021-08-27",{"date":140,"type":21},"2026-06",{"name":142,"class":47},"Corewell Health West",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":77},"100571836","nissen-versus-dor-hiatal-hernia-repair-100571836","NCT06725433","Nissen Versus Dor Hiatal Hernia Repair","NiDor-study: a Randomized Controlled Trial Comparing Nissen and Dor Fundoplication in Hiatal Hernia Repair","NiDor","Inclusion Criteria:\n\n* At least 18 years of age\n* Type II-IV hiatal hernia, confirmed by radiology or endoscopy\n* Scheduled for mini-invasive hiatal hernia repair\n* Emergency mini-invasive surgery for hiatal hernia\n* The informed consent is acquired\n\nExclusion Criteria:\n\n* Recurrent hiatal hernia\n* Need for esophageal lengthening procedure (Collis)\n* Gangrene or need for any resection during (emergency) surgery\n* Need for laparotomy or thoracotomy\u002Fthoracoscopy\n* No written consent",{"count":152,"type":21},150,[24],"Hiatal hernia can present with a wide range of symptoms. An usual surgical repair technique usually includes Nissen fundoplication, while other procedures are less frequently employed. However, recurrence and reoperation rates remain high. This randomized controlled trial aims to compare the efficacy of Nissen and Dor fundoplication in preventing hiatal hernia recurrence and reducing the risk of reoperation\n\nParticipants undergoing minimally invasive hiatal hernia repair will be randomly assigned to either Nissen or Dor fundoplication. Postoperatively at 12 months, anatomical recurrence rates based on computed tomography scans and symptomatic recurrence rates, anti-reflux medication use, GERD-related quality of life, and dysphagia symptoms will be assessed. A subsequent long-term follow-up study will conducted afterwards utilizing national registry data to evaluate reoperation rates and anti-reflux medication use",[28,30,156],"Recurrence","2025-02-17",{"date":159,"type":40},"2025-02-19",{"date":161,"type":40},"2025-02-07",{"date":163,"type":21},"2030-01-30",{"name":165,"class":47},"Kuopio University Hospital",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100524354","gastropexy-in-the-repair-of-patients-with-paraesophageal-hernias-100524354","NCT06107634","Gastropexy in the Repair of Patients with Paraesophageal Hernias","Can Gastropexy Improve the Efficacy of the Crural Repair in Patients with Paraesophageal Hernias? a Double Blind, Randomized, Multicenter Clinical Trial","PEH3","Inclusion Criteria:\n\n\\- Patients diagnosed with a primary paraesophageal hernia (hiatal hernia types II-IV) who are scheduled for elective or emergency surgical repair at participating centers\n\nExclusion Criteria:\n\n* Previous major upper gastrointestinal (GI) surgery, including prior hiatal hernia repair.\n* Diagnosis of achalasia or any other significant esophageal motility disorder.\n* Inability to understand the purpose of the study and\u002For inability or unwillingness to provide informed consent.\n* Severe comorbidities, defined by an American Society of Anesthesiologists (ASA) physical status score of greater than III.",{"count":175,"type":21},124,[24],"Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy.",[30],"2024-12-13",{"date":181,"type":40},"2024-12-18",{"date":183,"type":40},"2023-06-01",{"date":185,"type":21},"2030-08-02",{"name":187,"class":47},"Ersta Diakoni",6,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100523493","gastropexy-as-a-treatment-option-for-paraesophageal-hernia-100523493","NCT06096402","Gastropexy as a Treatment Option for Paraesophageal Hernia","Selective Anterior Gastropexy as a Surgical Treatment Option for Paraesophageal Hernia","Inclusion Criteria:\n\n\\- Both emergent and elective repair of the paraoesophageal hernia\n\nExclusion Criteria:\n\n\\-",{"count":197,"type":21},220,"The present proposal aims to asses which is the optimal treatment strategy in a clinical study in patients with paraoesophageal hernia (PEH), a condition often found in elderly, fragile patients The investigator want to study the optimal approach to a paraoesophageal hernia (PEH) repair. The incidence of PEH increases with age and the older patient typically has additional co-morbidities, reduced physiological fitness, and frailty which makes surgery challenging regarding increased morbidity and mortality. Thus, the decision to offer surgery can be challenging in this cohort of patients. The need of an anti-reflux procedure as part of the repair is one of the main subjects for discussion worldwide. To date no consensus exists and many surgical centres do a routine anti-reflux procedure as part of their standard operation for PEH. But is this procedure redundant? Can the patients be managed with a less complicated procedure; an anterior gastropexy with comparable outcome?",[30],[201,202,34],"paraesophageal hernia","gastropexy","2023-10-20",{"date":205,"type":40},"2023-10-23",{"date":207,"type":21},"2024-06-01",{"date":209,"type":21},"2027-12-31",{"name":211,"class":47},"University Hospital of North Norway",3,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":77},"100454743","sutures-versus-polyglactin-mesh-in-hiatal-hernia-repair-100454743","NCT05201508","Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair","Sutures Only Versus Absorbable Polyglactin (Vicryl®) Mesh in Closure of Hiatal Defect in Laparoscopic Paraesophageal Hernia Repair: Randomized Controlled Trial.","Inclusion Criteria:\n\n* Over 18 years old\n* Type III-IV PEH with either radiologic or endoscopic confirmation\n* Scheduled for laparoscopic PEH repair\n* The informed consent is acquired\n\nExclusion Criteria:\n\n* Need for esophagus lengthening procedure (Collis gastroplasty)\n* Recurrent PEH\n* Emergency surgery\n* No written consent",{"count":221,"type":21},110,[24],"Paraesophageal hernia causes pain, heartburn, regurgitation, anemia and in extreme, life-threatening strangulation. For symptomatic patients, laparoscopic surgery is offered which includes hiatal defect closure and antireflux surgery. However, recurrence rates are high between 12 and 42%. In order to reduce recurrences, mesh has been used with various materials and techniques with conflicting results. Non-absorbable mesh has been linked with adverse events including erosion of esophageal wall. Traditionally used biological mesh materials are expensive and therefore problematic in routine use. Use of polyglactin (Vicryl®) mesh, which degrades in 6-8 week, has been reported in paraesophageal hernia surgery. Previously, no randomized controlled trial comparing sutures only and polyglactin mesh has been performed. In this trial, the aim was to randomize total of 110 patients to receive sutures only or mesh repair. Primary outcome was recurrence of paraesophageal hernia at 6 months after the repair based on computed tomography scan. Secondary outcomes included symptomatic recurrences, reoperation rate, quality of life, reoperations up to 20-years after surgery and use of proton pump inhibitors up to 20-years after surgery.",[30,28,225,156],"Hiatal Hernia, Paraesophageal","2023-03-24",{"date":228,"type":40},"2023-03-27",{"date":230,"type":40},"2022-01-21",{"date":232,"type":21},"2043-01-01",{"name":234,"class":47},"Oulu University Hospital"]