Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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