[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiatal-hernia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiatal-hernia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,81,114,141,164,186,207,232],{"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":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100613507","image-guided-herniorrhaphy-study-100613507","NCT07267494","Image-Guided Herniorrhaphy Study","Image-guided Herniorrhaphy Safety and Efficacy Pilot","Inclusion Criteria:\n\n* English-speaking adult with reducible hernia(s) or diastasis smaller than approximately 8 cm seeking treatment for their hernia but not able or willing to undergo traditional surgery (open, laparoscopic, or robotic)\n* Patient must be willing to undergo a novel 30- to 60-minute image-guided needle-based procedure\n\nExclusion Criteria:\n\n* Children, prisoners, and pregnant women (possibly requiring a pregnancy test on the day of the procedure)\n* Patients with a known reaction to local anesthetic or sedation medications or the suture material to be used\n* Patients with irreducible hernias\n* Patients with herniation not visible by ultrasound or CT\n* Patients that do not fit the diameter of a CT gantry or the weight limit of the procedural CT table\n* Patients without insurance or not willing to pay out-of-pocket for the study procedure",{"count":57,"type":21},30,[24],"This pilot clinical study will evaluate the safety and effectiveness of a new image-guided, needle-based approach for repairing abdominal or groin hernias in adults who are unable or unwilling to undergo traditional open or laparoscopic surgery. The technique uses ultrasound and, when needed, CT imaging to guide a hollow needle preloaded with barbed suture through the skin to close the hernia defect without large incisions or general anesthesia. Each participant will undergo one image-guided procedure and will be followed for eight months to assess complications and changes in hernia-related quality of life. Approximately thirty participants will be enrolled. The study aims to determine whether this minimally invasive approach is safe, feasible, and capable of improving hernia symptoms enough to justify a larger clinical trial",[61,62,63,64,28,65],"Hernia","Hernia Abdominal Wall","Ventral Hernia","Inguinal Hernia","Diastasis Recti",[67,68,69,70,71],"Image-guided herniorrhaphy","hernia","pilot study","quality of life","safety and feasability","2026-06-12",{"date":37,"type":40},{"date":75,"type":21},"2026-12-01",{"date":77,"type":21},"2029-05-01",{"name":79,"class":47},"University of California, Davis",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":80},"100077248","esophageal-cancer-risk-registry-100077248","NCT00260585","Esophageal Cancer Risk Registry","Inclusion Criteria:\n\n* Known or suspected esophageal or gastroesophageal junction malignancy\n* Known Barrett's metaplasia\n* Clinical management of symptomatic gastroesophageal reflux disease (GERD)\n* Achalasia\n* Hiatal hernia\n\nExclusion Criteria:\n\n* Elevated pre-operative bloodwork will not have the additional biopsies taken.\n* Platelet count less than 150,000, partial thromboplastin time (PTT) of 50 or above, and\u002For International Normalized Ratio (INR) of 1.8 or above will not have the additional biopsies taken.",{"count":88,"type":21},7000,"OBSERVATIONAL","The purpose of this study is to identify markers in the blood and tissue that could indicate risk factors for the development and progression of esophagus cancer. This research aims to collect medical history, blood, and tissue samples from patients who present with an esophageal disorder. Identifying genetic and behavioral risk factors involved in the development of esophageal cancer might allow for early detection and prevention. Survival and an opportunity for a cure with esophageal cancer will depend greatly on the stage of diagnosis. Tumors can develop changes in their genetic (hereditary) make-up, and these changes can sometimes be seen in normal tissues before the development of cancer. These genetic (hereditary) changes can serve as tumor markers and can be detected using methods that study changes in genetic material like DNA and RNA. The analysis of proteins can provide additional information. By identifying changes in these molecules that are different or altered in cancer, the investigators can use methods and tests for the detection of these changes.",[92,93,94,28,95],"Esophageal Cancer","Gastroesophageal Reflux Disease (GERD)","Esophageal Diseases","Esophageal Achalasia",[97,27,33,98,99,100,101,102,103],"gastroesophageal reflux disease","achalasia","Barrett's metaplasia","Anti-Reflux Surgery","Known\u002Fsuspected esophageal\u002Fgastroesophageal junction tumor","Esophageal disorders such as Barrett's metaplasia","Symptomatic gastroesophageal reflux disease","RECRUITING","2026-04-09",{"date":107,"type":40},"2026-04-14",{"date":109,"type":40},"1999-06",{"date":111,"type":21},"2050-12",{"name":113,"class":47},"University of Pittsburgh",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":122,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":48},"100598332","evaluating-clinical-hiatal-hernia-outcomes-using-ovitex-100598332","NCT07070115","Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®","A Prospective Study Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® Reinforced Tissue Matrix","ECH2O2","Inclusion Criteria:\n\n1. Patient is a candidate for an elective robotic or laparoscopic primary hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable.\n2. Patient is willing and able to voluntarily sign the IRB-approved Informed Consent Form for the study.\n3. Patient is at least 22 years old at the time of surgery.\n4. Patient is not pregnant and not planning to become pregnant during the duration of the study (5 years).\n5. Patient is able and willing to comply with the study requirements including completion of patient questionnaires and clinic evaluations.\n\nExclusion Criteria (Baseline):\n\n1. Patient has a Body Mass Index (BMI) of ≥ 35.\n2. Patient meets the Centers for Disease Control (CDC) Surgical Site Infection (SSI) Wound Classification Class IV (Dirty-Infected) criteria.\n3. Patient has a Type I hiatal hernia (defined as only the esophagogastric junction is above the diaphragm).\n4. Patient has a life expectancy of less than five years making it unlikely that the subject will successfully achieve five-year follow-up.\n5. Patient is a current nicotine user (including smokeless, vaporized, etc.)\n6. Patient has a history of illicit drug or alcohol abuse (in the last three years).\n7. Patient has an allergy to ovine-derived products or a known sensitivity to polyglycolic acid (PGA).\n8. Patient has an allergy to barium.\n9. Patient's surgery will include the use of an anti-reflux implantable device (LINX, etc.).\n10. Patient's surgery requires the use of an additional mesh device or a pledget for reinforcement.\n11. Patient has participated in another gastrointestinal (GI) clinical study within the past 30 days or is currently involved in another clinical study excluding observational and registry studies.\n12. Patient had previous surgery at the gastroesophageal junction.\n13. Patient had a prior hiatal hernia repair.\n14. Patient has an incarcerated hernia that requires emergent intervention.\n15. Patient is a prisoner.\n\nExclusion Criteria (Intra-operative):\n\n1. Patient is unable to receive OviTex Core Resorbable or OviTex 1S Resorbable at time of surgery.\n2. Surgery requires the use of an additional mesh device or a pledget for reinforcement.\n3. Surgery includes the use of an anti-reflux implantable device (LINX, etc.).\n4. Surgery performed as an open procedure.\n5. Patient has a condition, which in the Investigator's opinion, may put the patient at increased risk, confound study data, or interfere significantly with the patient's participation in the study.","22 Years",{"count":124,"type":21},173,[24],"This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.",[28],[129,68,130],"hiatal","reinforced tissue matrix","2026-02-05",{"date":133,"type":40},"2026-02-09",{"date":135,"type":40},"2025-07-25",{"date":137,"type":21},"2032-07-31",{"name":139,"class":140},"Tela Bio Inc","INDUSTRY",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":163},"100550228","impact-of-biosynthetic-mesh-on-paraesophageal-hernia-repair-100550228","NCT06444347","Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair","The Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair in Robotic Anti-Reflux Surgery: A Multi-Institutional Randomized Trial","Inclusion Criteria:\n\n* Documented diagnosis of gastroesophageal reflux disease\n* Adults aged 18 years or older\n* English speaking\n* Subject is planned to undergo surgery for reflux disease\n\nExclusion Criteria:\n\n* Physician deems the subject is unable to complete the study due to documented dementia.\n* Subject is undergoing emergent surgery.\n* Pregnancy\n* Patient has known allergy to tetracycline hydrochloride or kanamycin sulfate",true,{"count":150,"type":21},200,[24],"The aim of this study is to find out if using a certain kind of mesh can reduce the chances of hiatal hernias coming back after anti-reflux surgery. Participants undergoing antireflux surgery will be assigned to one of two groups, a group that has surgery with mesh, or a group that has surgery without mesh.",[28],"2025-11-17",{"date":156,"type":40},"2025-11-18",{"date":158,"type":40},"2024-06-10",{"date":160,"type":21},"2030-07",{"name":162,"class":47},"Weill Medical College of Cornell University",6,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":80},"100580322","comparative-3-year-study-of-nissen-sleeve-vs-sleeve-plus-cruroplasty-in-obese-patients-with-hiatal-hernia-100580322","NCT06835790","Comparative 3-year Study of Nissen-sleeve vs. Sleeve Plus Cruroplasty in Obese Patients With Hiatal Hernia","HH-N Sleeve","Inclusion Criteria:\n\n* Adult patient,\n* Patient with severe obesity (BMI \\>35) with comorbidity or morbidity (BMI \\>40),\n* Patient awaiting a sleeve gastrectomy,\n* Patient with a hiatal hernia \\\u003Cor= 4 cm,\n* Patient having undergone a gastroscopy,\n* Patient having undergone an esophagogastroduodenal transit (OGDT),\n* Patient having been informed and having given their free, informed and written consent,\n* Patient affiliated with or beneficiary of a social security scheme.\n\nExclusion Criteria:\n\n* Patient with poorly controlled diabetes,\n* Patient with major esophageal motility disorders,\n* Patient with a Hiatal Hernia \\> 4cm,\n* History of bariatric surgery, history of ring,\n* Patient refusing pH-metry examination,\n* Refusal to participate in the study,\n* Patient under legal protection,\n* Patient not benefiting from health protection,\n* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.",{"count":172,"type":21},150,[24],"The success of laparoscopic sleeve gastrectomy (LSG) is not only due to its proven efficacy in the treatment of obesity and associated to comorbidities in the short and long term, but also because it is considered as less technically complicated compared to other malabsorptive procedures. Unfortunately, the main long-term side effect of LSG appears to be the development of severe gastroesophageal reflux (GERD). This problem is aggravated by the concomitant presence of a hiatal hernia at the time of surgery. Indeed, by causing laxity of the lower esophageal sphincter (LES), the hiatal hernia reduces the barrier functions of the esophageal-gastric junction against the reflux of gastric contents.\n\nThe classic combination of sleeve and hiatal hernia treatment by cruroplasty gives contradictory results and several surgeons prefer to perform only the sleeve without addressing the hiatal hernia especially if it is small (\\\u003C4 cm). For this reason a modification of the usual surgical technique of LSG has been proposed by adding a Nissen fundoplication-Nissen Sleeve (NS). The intentions of this technique were to minimize the rate of postoperative GERD especially for patients with hiatal hernia, to protect the staple line of the angle of His, and finally to provide a safe and effective alternative for patients with a contraindication to LRYGB due to GERD. Although the first results of the technique are encouraging, the realization of the Nissen valve remains a sensitive technical point that can transform a relatively simple procedure like LSG into a more complex procedure like NS. The only test able to directly identify and classify gastric reflux is pH-metry with or without esophageal manometry. Unfortunately, especially due to the difficulty of access to the examination, there are no studies with solid scientific bases that identify the correct conduct to adopt in the case of an obese patient with a hiatal hernia (with or without preoperative reflux).\n\nThe main objective of this study is to evaluate the occurence or worsening of GERD at 3 years following a Nissen-sleeve vs. sleeve plus cruroplasty intervention in patients with obesity and hiatal hernia.",[176,28],"Obesity","2025-02-18",{"date":179,"type":40},"2025-02-19",{"date":181,"type":21},"2025-03-02",{"date":183,"type":21},"2031-11-02",{"name":185,"class":47},"Elsan",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":80},"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":172,"type":21},[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",[28,30,198],"Recurrence","2025-02-17",{"date":179,"type":40},{"date":202,"type":40},"2025-02-07",{"date":204,"type":21},"2030-01-30",{"name":206,"class":47},"Kuopio University Hospital",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":216,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":4},"100407932","a-prospective-randomised-multi---center-trial-on-the-repair-of-large-hiatal-hernias-absorbable-mesh-vs-pledgeted-sutures-vs-sutures-only-100407932","NCT04591860","A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only","A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh","Inclusion Criteria:\n\n* Patients with a large hiatal hernia - admitted for surgery (laparoscopic \u002F robot-assisted)\n* Written informed consent\n* ≥ 18 years of age\n* Hiatal hernia documented by barium x-ray and\u002For gastroscopy and\u002For manometry by one or more of the following criteria:\n\n  * \\> 5cm hiatal hernia\n  * 1\u002F3 of the stomach in the thorax\n\nExclusion Criteria:\n\n* Lack of patient consent for study participation\n* Lack of consent to study due to linguistic or mental incomprehension\n* Patients in poor general condition (lack of anesthesia ability)\n* Pregnancy\n* Prior surgery on the stomach or gastroesophageal junction\n* Simultaneous surgery because of another illness",{"count":215,"type":21},165,[24],"A prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable mesh\n\nThe primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh).\n\nThe duration of the study is not limited and depends on the number of cases planned. After enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.",[28],[33,220,221,222],"pledgets","mesh","hernia recurrence","2024-04-01",{"date":225,"type":40},"2024-04-02",{"date":227,"type":21},"2024-05-01",{"date":229,"type":21},"2027-05-01",{"name":231,"class":47},"Paracelsus Medical University",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":80},"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":240,"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.",[30,28,244,198],"Hiatal Hernia, Paraesophageal","2023-03-24",{"date":247,"type":40},"2023-03-27",{"date":249,"type":40},"2022-01-21",{"date":251,"type":21},"2043-01-01",{"name":253,"class":47},"Oulu University Hospital"]