RecruitingNot ApplicableNCT07426835

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

Royal College of Surgeons, Ireland

Enrollment

40 participants

Start Date

Dec 19, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (the PHARO Trial) is testing whether closing the opening in the diaphragm (the hiatus) during robotic oesophageal cancer surgery reduces the risk of a hernia forming next to the stomach tube after the operation. It is a randomised pilot trial comparing the standard surgical approach to closure of this gap. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with oesophageal (gullet) cancer - You are scheduled for robotic surgery to remove part of your oesophagus with the aim of a cure - There is no evidence of cancer spread to distant parts of your body - You are able to give written informed consent **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You are not a suitable candidate for robotic oesophageal surgery - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREStandard Hiatal Management

Robotic oesophagectomy performed with no hiatal closure or partial hiatal closure according to standard surgical practice.

PROCEDUREHiatal Closure With Omentopexy and Left Crus Fixation

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.


Locations(1)

Beaumont RCSI Cancer Centre

Dublin, Beaumont, Ireland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07426835