Actively Recruiting
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
Led by Royal College of Surgeons, Ireland · Updated on 2026-02-23
40
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of oesophageal cancer
- Planned robotic oesophagectomy with curative intent
- No clinical or radiological evidence of distant metastases at recruitment
- Able to provide written informed consent
You will not qualify if you...
- Evidence of distant metastatic disease
- Not suitable for robotic oesophagectomy
- Unable to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beaumont RCSI Cancer Centre
Dublin, Beaumont, Ireland, D09V2N0
Actively Recruiting
Research Team
P
Prof Jarlath Bolger
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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