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

Inclusion Criteria5

  • 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 Criteria3

  • Evidence of distant metastatic disease
  • Not suitable for robotic oesophagectomy
  • Inability to provide informed consent

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

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NCT07426835