[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hernia-hiatal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hernia-hiatal":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,79],{"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":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100417629","gore-enform-biomaterial-product-study-100417629",false,"NCT04718168","GORE® ENFORM Biomaterial Product Study","GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients","ENF 18-06","Pre-procedure Inclusion Criteria:\n\nThe subject is \u002F has:\n\n1. At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).\n2. An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.\n3. A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.\n4. An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.\n5. Willing to provide informed consent and comply with follow-up requirements.\n\nPre-procedure Exclusion Criteria:\n\nThe subject is \u002F has:\n\n1. Treated in another drug or medical device study within 1 year of study enrollment.\n2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.\n3. Hernia repair expected to be performed as part of a bridged procedure (i.e., expected inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).\n4. A BMI \\>40.\n5. Evidence of a systemic infection.\n6. Cirrhosis or undergoing dialysis.\n7. A wound-healing disorder.\n8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.\n9. Expected to undergo mesh implantation in conjunction with any bariatric procedure and \u002F or panniculectomy procedure.\n10. A stoma.\n11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\n12. Positive pregnancy or lactation status as confirmed by site standard of care.\n13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.\n\nPost-procedure Inclusion Criteria\n\nAt the time of index procedure, the subject is \u002F has:\n\n1. At least 18 years old. Minimum age required by state regulations (as applicable).\n2. Implanted with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture-line reinforcement on or before 365 days prior to site protocol amendment 3 approval date.\n3. Unless there is an Informed Consent waiver issued by the Institutional Review Board (IRB), an Informed Consent Form (ICF) signed by subject.\n\nPost-procedure Exclusion Criteria\n\nAt the time of index procedure, the subject is \u002F has:\n\n1. Treated in another drug or medical device study within 1 year of study enrollment.\n2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.\n3. Hernia repair that was performed as part of a bridged procedure (i.e., inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).\n4. A BMI \\>40.\n5. Evidence of a systemic infection.\n6. Cirrhosis or undergoing dialysis.\n7. A wound-healing disorder.\n8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.\n9. Underwent mesh implantation in conjunction with any bariatric procedure and \u002F or panniculectomy procedure.\n10. A stoma.\n11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\n12. Positive pregnancy or lactation status as confirmed by site standard of care.\n13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.","ALL","18 Years",{"count":20,"type":21},245,"ESTIMATED","INTERVENTIONAL",[24],"NA","A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral \u002F Incisional Hernia Repair and Diaphragmatic \u002F Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and short-term patient experience.",[27,28,29,30],"Hernia, Ventral","Hernia, Hiatal","Hernia, Diaphragmatic","Incisional Hernia",[32,33,34,35,36,37,38,39,40],"hernia","ventral","hiatal","diaphragmatic","incisional","mesh","Gore","W.L. Gore","Enform","RECRUITING","2026-02-17",{"date":44,"type":45},"2026-02-18","ACTUAL",{"date":47,"type":45},"2021-05-17",{"date":49,"type":21},"2026-09",{"name":51,"class":52},"W.L.Gore & Associates","INDUSTRY",9,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100612325","tlsa-versus-tbsa-surgical-approach-for-hiatal-hernia-with-gastroesophageal-reflux-disease-100612325","NCT07252115","TLSA Versus TBSA Surgical Approach for Hiatal Hernia With Gastroesophageal Reflux Disease","Multicenter Randomized Clinical Trial on the Efficacy and Safety of the Total Left-side Surgical Approach (TLSA) Versus the Traditional Bilateral Surgical Approach (TBSA) for Hiatal Hernia With Gastroesophageal Reflux Disease","Inclusion Criteria:\n\n* Patients aged 18 to 85 years.\n* Confirmed diagnosis of hiatal hernia (type I to IV).\n* Diagnosis of refractory GERD, defined as persistent symptoms despite receiving 40 mg daily omeprazole for 8-12 weeks.\n* GERD confirmed by either:\n* Increased esophageal acid exposure time (AET) on 24-hour pH monitoring, and\u002For\n* Endoscopic evidence of esophagitis.\n* Hiatal hernia diagnosis verified by both abdominal CT and gastroscopy.\n\nExclusion Criteria:\n\n* Presence of GERD without a hiatal hernia.\n* Esophageal motility disorder.\n* History of esophageal or other upper abdominal surgery.","85 Years",{"count":63,"type":21},143,[24],"Gastroesophageal reflux disease (GERD), characterized by pathological reflux of gastric contents, affects 10%-20% of the global population with Western predominance and escalating incidence over recent decades. Anatomical and functional abnormalities of the esophagogastric junction (EGJ) such as hiatal hernia (HH) is one of the major pathophysiological mechanisms. GERD elevates risks for Barrett esophagus, esophageal adenocarcinoma and interstitial pulmonary fibrosis, while characteristic symptoms including reflux and heartburn substantially impair quality of life (QoL). Proton pump inhibitors (PPIs) are used to alleviate symptoms and prevent reflux-related esophageal mucosal damage, but may cause long-term adverse effects.\n\nAnti-reflux surgery (ARS) is a well-established therapeutic option for patients with anatomical abnormalities, chronic PPI-refractory symptoms or unwilling to take lifelong PPIs. It provides comparable or potentially superior efficacy to PPIs, especially in reconstructing anatomical structures and addressing EGJ functional deficiencies. Maximize patients' QoL while minimizing side effects is priority for ARS. Despite advancements in surgical techniques, ARS remains invasive and is associated with inherent mechanical complications, including dysphagia and potential vagus nerve injury. A growing consensus recognizes that hepatic vagus nerve injury, occurring in a significant proportion of patients following ARS, potentially contributes to postoperative dysfunctions such as delayed gastric emptying, impaired reflux control, dyspeptic symptoms, cholelithiasis, ultimately diminishing QoL.\n\nAlthough the traditional bilateral surgical approach (TBSA) is widely used, its requisite dissection of the lesser omentum invariably injures or severs the hepatic branch of the vagus nerve. The hepatic branch of the vagus arises from the anterior trunk and predominantly innervates the gastric antrum, pylorus, proximal duodenum and biliary tract. Functionally, it mediates a spectrum of vital physiological process including hepato-gastric reflexes that facilitate gastric motility via osmotic sensing, as well as glucose-sensitive reflexes that inhibit gastric motility and delay gastric emptying. Furthermore, hepatic branch is involved in food intake and metabolic homeostasis, and it exerts parasympathetic control over the coordinated contraction of the gallbladder and sphincter of Oddi. However, the functional preservation of the hepatic branch of the vagus nerve during ARS remains poorly understood, with limited clinical evidence and absent robust guidelines.\n\nBased on our preliminary findings, we initiated a long-term evaluation of the total left-side approach (TLSA), a nerve-sparing strategy that preserves the lesser omentum and hepatogastric ligament to safeguard the hepatic branch of the vagus nerve, with the aim of enhancing postoperative QoL.",[28,67],"GERD (Gastroesophageal Reflux Disease)","2025-11-25",{"date":70,"type":45},"2025-11-26",{"date":72,"type":45},"2024-04-04",{"date":74,"type":21},"2026-12-31",{"name":76,"class":77},"Beijing Friendship Hospital","OTHER",2,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100572730","low-pressure-pneumoperitoneum-using-airseal-for-reduction-in-postoperative-shoulder-pain-following-robot-assisted-hiatal-hernia-repair-100572730","NCT06737068","Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair","Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair: a Prospective Randomized Controlled Trial.","Inclusion Criteria:\n\n* patients undergoing elective robot assisted hiatal hernia repair\n\nExclusion Criteria:\n\n* patients less than 18 years of age\n* conversion to open surgery\n* BMI \\> 40\n* history of abdominoplasty\n* history of chronic pain and\u002For opioid dependence\n* history of COPD and\u002For supplemental oxygen use\n* pregnant patients\n* incarcerated patients\n* patient refusal",{"count":87,"type":21},120,[24],"The goal of this clinical trial is to evaluate the incidence and severity of post-operative shoulder pain following elective robot-assisted hiatal hernia repair in hopes of reducing pain and associated costs as well as clinic and emergency department visits due to this pain. You will undergo standard robot-assisted hiatal hernia repair with the standard postoperative care. The only difference is that you may be selected for the group where lower pressures used to fill your abdomen with carbon dioxide will be used, and you will be asked to fill out logs regarding your pain postoperatively. You will have postoperative appointments that are standard following this procedure.",[28,91,92,93],"Pneumoperitoneum","Postoperative Pain","Shoulder Pain","NOT_YET_RECRUITING","2024-12-11",{"date":97,"type":45},"2024-12-17",{"date":99,"type":21},"2025-01-01",{"date":101,"type":21},"2027-01",{"name":103,"class":77},"Riverside University Health System Medical Center",1]