[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625761":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":55,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Royal College of Surgeons, Ireland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Hiatal Management","ACTIVE_COMPARATOR","Participants randomised to this group will undergo robotic oesophagectomy with standard hiatal management, consisting of no hiatal closure or partial hiatal closure according to current institutional practice. All other aspects of perioperative care and postoperative surveillance will follow standard clinical protocols.",[13],"Procedure: Standard Hiatal Management",{"label":15,"type":16,"description":17,"interventionNames":18},"Hiatal Closure With Omentopexy and Left Crus Fixation","EXPERIMENTAL","Participants randomised to this group will undergo robotic oesophagectomy with complete hiatal closure followed by omentopexy and thoracic fixation of the left crus. A standardised operative technique will be used to ensure consistency across cases. Postoperative care and surveillance will follow standard clinical protocols.",[19],"Procedure: Hiatal Closure With Omentopexy and Left Crus Fixation",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Robotic oesophagectomy performed with no hiatal closure or partial hiatal closure according to standard surgical practice.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Robotic oesophagectomy including complete hiatal closure of the diaphragmatic hiatus, omentopexy of the gastric conduit, and thoracic fixation of the left crus using a standardised operative technique.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Prof Jarlath Bolger","CONTACT","+35318093000","jarbolger@rcsi.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Beaumont RCSI Cancer Centre","RECRUITING","Dublin","Beaumont","D09V2N0","Ireland","IE",{"type":45,"coordinates":46},"Point",[47,48],-6.24889,53.33306,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":53,"phoneExt":25,"email":54},"Aisling Hegarty, PhD","018093000","Aislinghegarty@rcsi.ie",{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100625761","the-pharo-trial-the-incidence-of-para-conduit-hernia-with-closure-of-hiatus-versus-the-standard-approach-in-robotic-oesophagectomy---a-randomised-controlled-pilot-trial-100625761",false,"NCT07426835","The PHARO Trial: The Incidence of Para-conduit Hernia With Closure of Hiatus Versus the Standard Approach in Robotic Oesophagectomy - A Randomised Controlled Pilot Trial","PHARO","Inclusion Criteria:\n\nAge ≥ 18 years\n\nDiagnosis of oesophageal cancer\n\nPlanned robotic oesophagectomy with curative intent\n\nNo clinical or radiological evidence of distant metastases at time of recruitment\n\nAble to provide written informed consent\n\nExclusion Criteria:\n\nEvidence of distant metastatic disease\n\nNot suitable for robotic oesophagectomy\n\nInability to provide informed consent","ALL","18 Years",{"count":67,"type":68},40,"ESTIMATED","INTERVENTIONAL",[71],"NA","Para-conduit hernia is a recognised complication following minimally invasive and robotic oesophagectomy. It may present as an incidental radiological finding or as a symptomatic hernia requiring urgent surgical intervention. There is currently no standardised approach to hiatal management during robotic oesophagectomy.\n\nThe PHARO trial is a single-centre, randomised controlled pilot study evaluating whether routine hiatal closure with omentopexy and thoracic fixation of the left crus reduces the incidence of para-conduit hernia compared to the standard approach of no closure or partial closure.\n\nEligible patients undergoing robotic oesophagectomy for non-metastatic oesophageal cancer at Beaumont Hospital will be randomised in a 1:1 ratio to:\n\nStandard hiatal management (no closure or partial closure), or Hiatal closure with omentopexy and thoracic fixation of the left crus.\n\nParticipants will undergo routine postoperative clinical and radiological surveillance. The primary outcome is the incidence of para-conduit hernia within one year following surgery. Secondary outcomes include dysphagia scores, patient-reported outcomes, and 30-day postoperative morbidity.\n\nThis pilot study will enrol 40 participants (20 per group) to inform feasibility and future multi-centre expansion.",[74,75],"Oesphageal Cancer","Para-conduit Hernia",[77,78,79,80,75,81,82,83,84],"Robotic Oesophagectomy","Robot-Assisted Surgery","Hiatal Closure","Omentopexy","Minimally Invasive Oesophagectomy","Upper Gastrointestinal Surgery","Dysphagia","Edinburgh Dysphagia Score","2026-02-16",{"date":87,"type":88},"2026-02-23","ACTUAL",{"date":90,"type":88},"2025-12-19",{"date":92,"type":68},"2029-12-31",{"name":5,"class":6},1]