[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572730":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":33,"locations":34,"responsibleParty":58,"collaborators":33,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":33,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":33,"enrollmentInfo":69,"targetDuration":33,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":33,"overallStatus":81,"whyStopped":33,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Riverside University Health System Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low Pressure Pneumoperitoneum (8-10 mmHg)","EXPERIMENTAL","Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 8-10 mmHg throughout the case",[13],"Procedure: Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device",{"label":15,"type":6,"description":16,"interventionNames":17},"Standard Pressure Pneumoperitoneum (13-15 mmHg)","Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 13-15 mmHg throughout the case",[18],"Procedure: Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device","Elective robot assisted hiatal hernia repair with low pressure pneumoperitoneum (8-10mmHg) with AirSeal device",[9],[26],"low pressure",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device","Elective robot assisted hiatal hernia repair with standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device",[15],[32],"standard pressure",null,[35],{"facility":36,"status":33,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Riverside University Health System","Moreno Valley","California","92555","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-117.23059,33.93752,{"lat":46,"lon":45},[49,54,56],{"name":50,"role":51,"phone":52,"phoneExt":33,"email":53},"Institutional Review Board Manager","CONTACT","951-486-4452","G.Moulton@RUHealth.org",{"name":55,"role":51,"phone":33,"phoneExt":33,"email":33},"Marcos Michelotti, MD",{"name":57,"role":51,"phone":33,"phoneExt":33,"email":33},"Lan-Anh A Nguyen, MD",{"type":59,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100572730","low-pressure-pneumoperitoneum-using-airseal-for-reduction-in-postoperative-shoulder-pain-following-robot-assisted-hiatal-hernia-repair-100572730",false,"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","ALL","18 Years",{"count":70,"type":71},120,"ESTIMATED","INTERVENTIONAL",[74],"NA","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.",[77,78,79,80],"Hernia, Hiatal","Pneumoperitoneum","Postoperative Pain","Shoulder Pain","NOT_YET_RECRUITING","2024-12-11",{"date":84,"type":85},"2024-12-17","ACTUAL",{"date":87,"type":71},"2025-01-01",{"date":89,"type":71},"2027-01",{"name":5,"class":6},1]