Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:32 PM
Study NCT ID:
NCT07426835
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be blinded to treatment allocation. Surgeons cannot be blinded due to the intraoperative nature of the intervention. Data analysts and those assessing questionnaire outcomes will be blinded to allocation during analysis where feasible.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a single-centre, prospective, single-blinded, pilot randomised controlled trial. Eligible patients undergoing robotic oesophagectomy for non-metastatic oesophageal cancer will be randomised in a 1:1 ratio to either standard hiatal management (no closure or partial closure) or hiatal closure with omentopexy and thoracic fixation of the left crus. Randomisation will be performed using an online randomisation system with sequential study numbers assigned. Participants will be blinded to allocation. Follow-up will include routine clinical and radiological surveillance up to 12 months postoperatively.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Para-conduit Hernia', 'timeFrame': 'Up to 12 months postoperatively (reference time point: 12-month surveillance CT scan)', 'description': 'Proportion of participants diagnosed with para-conduit hernia following robotic oesophagectomy. Para-conduit hernia is defined as either:\n\n* Symptomatic hernia requiring operative intervention (clinical diagnosis), or\n* Radiological evidence of hernia identified on surveillance computed tomography (CT) imaging.\n\nFor primary endpoint analysis, the 12-month postoperative surveillance CT scan will serve as the reference time point. Radiological evidence identified on earlier surveillance scans (approximately 5-6 months) will be recorded descriptively but will not be included in the primary endpoint analysis.'}], 'secondaryOutcomes': [{'measure': 'Dysphagia Severity (Edinburgh Dysphagia Score)', 'timeFrame': 'Baseline and up to 12 months postoperatively', 'description': 'Dysphagia severity measured using the Edinburgh Dysphagia Score (EDS) during scheduled postoperative follow-up visits.'}, {'measure': 'Patient-Reported Outcomes (Quality of Life Measures)', 'timeFrame': 'Baseline and up to 12 months postoperatively', 'description': 'Change in patient-reported quality-of-life measures assessing physical, psychosocial, and functional well-being using validated questionnaires administered during follow-up.'}, {'measure': '30-Day Postoperative Morbidity', 'timeFrame': 'Within 30 days postoperatively', 'description': 'Incidence of clinically relevant postoperative complications occurring within 30 days of surgery, including bleeding, intensive care unit readmission, lower respiratory tract infection, and reoperation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Robotic Oesophagectomy', 'Robot-Assisted Surgery', 'Hiatal Closure', 'Omentopexy', 'Para-conduit Hernia', 'Minimally Invasive Oesophagectomy', 'Upper Gastrointestinal Surgery', 'Dysphagia', 'Edinburgh Dysphagia Score'], 'conditions': ['Oesphageal Cancer', 'Para-conduit Hernia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Background\n\nPara-conduit hernia is increasingly recognised following minimally invasive and robotic oesophagectomy. The incidence appears higher than in open surgery and may be associated with extensive mediastinal dissection and widened hiatus. Clinical presentation ranges from asymptomatic radiological detection to incarceration requiring urgent surgical repair.\n\nRobotic-assisted oesophagectomy offers technical advantages, including improved dexterity and visualisation. However, there is no consensus on whether routine hiatal closure reduces postoperative hernia formation.\n\nStudy Design\n\nThis is a prospective, single-centre, single-blinded, pilot randomised controlled trial conducted at Beaumont Hospital.\n\nParticipants will be randomised in a 1:1 ratio to:\n\nStandard hiatal management (control)\n\nHiatal closure with omentopexy and thoracic fixation (intervention)\n\nParticipants will be blinded to allocation. Surgeons cannot be blinded due to the nature of the intraoperative intervention. Outcome assessors and data analysts will be blinded where feasible.\n\nIntervention\n\nControl Arm:\n\nStandard approach of no hiatal closure or partial closure during robotic oesophagectomy.\n\nIntervention Arm:\n\nHiatal closure followed by omentopexy and thoracic fixation of the left crus. A standardised operative video will be circulated to ensure technique consistency.\n\nFollow-Up\n\nPatients undergo routine postoperative surveillance including CT imaging at approximately 5-6 months and 12 months. The 12-month CT scan will serve as the reference timepoint for primary endpoint analysis.\n\nSample Size\n\nThis pilot study will enrol 40 patients (20 per arm). Findings will inform design and power calculation for a future multi-centre phase II study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07426835', 'acronym': 'PHARO', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Royal College of Surgeons, Ireland'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '25-60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Hiatal Management', 'description': '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.', 'interventionNames': ['Procedure: Standard Hiatal Management']}, {'type': 'EXPERIMENTAL', 'label': 'Hiatal Closure With Omentopexy and Left Crus Fixation', 'description': '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.', 'interventionNames': ['Procedure: Hiatal Closure With Omentopexy and Left Crus Fixation']}], 'interventions': [{'name': 'Standard Hiatal Management', 'type': 'PROCEDURE', 'description': 'Robotic oesophagectomy performed with no hiatal closure or partial hiatal closure according to standard surgical practice.', 'armGroupLabels': ['Standard Hiatal Management']}, {'name': 'Hiatal Closure With Omentopexy and Left Crus Fixation', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Hiatal Closure With Omentopexy and Left Crus Fixation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D09V2N0', 'city': 'Dublin', 'state': 'Beaumont', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Aisling Hegarty, PhD', 'role': 'CONTACT', 'email': 'Aislinghegarty@rcsi.ie', 'phone': '018093000'}], 'facility': 'Beaumont RCSI Cancer Centre', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'centralContacts': [{'name': 'Prof Jarlath Bolger', 'role': 'CONTACT', 'email': 'jarbolger@rcsi.com', 'phone': '+35318093000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal College of Surgeons, Ireland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}