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
| NCT ID | NCT07426835 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal College of Surgeons, Ireland |
| Condition | Oesphageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-12-19 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-12-19 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The 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. Eligible patients undergoing robotic oesophagectomy for non-metastatic oesophageal cancer at Beaumont Hospital will be randomised in a 1:1 ratio to: Standard hiatal management (no closure or partial closure), or Hiatal closure with omentopexy and thoracic fixation of the left crus. Participants 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. This pilot study will enrol 40 participants (20 per group) to inform feasibility and future multi-centre expansion.
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Diagnosis of oesophageal cancer Planned robotic oesophagectomy with curative intent No clinical or radiological evidence of distant metastases at time of recruitment Able to provide written informed consent Exclusion Criteria: Evidence of distant metastatic disease Not suitable for robotic oesophagectomy Inability to provide informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07426835 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oesphageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07426835 currently recruiting?
Yes, NCT07426835 is actively recruiting participants. Contact the research team at jarbolger@rcsi.com for enrollment information.
Where is the NCT07426835 trial being conducted?
This trial is being conducted at Dublin, Ireland.
Who is sponsoring the NCT07426835 clinical trial?
NCT07426835 is sponsored by Royal College of Surgeons, Ireland. The trial plans to enroll 40 participants.
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