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

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard Hiatal Management: Robotic oesophagectomy performed with no hiatal closure or partial hiatal closure according to standard surgical practice.

Hiatal 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.

Study 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

Primary outcome measure(s)

• Incidence of Para-conduit Hernia — Up to 12 months postoperatively (reference time point: 12-month surveillance CT scan)
  Proportion of participants diagnosed with para-conduit hernia following robotic oesophagectomy. Para-conduit hernia is defined as either: * Symptomatic hernia requiring operative intervention (clinical diagnosis), or * Radiological evidence of hernia identified on surveillance computed tomography (CT) imaging. For primary endpoint analysis, the 12-month postoperative surveillance CT scan will serve as the reference time point. Radiological evidence identified on earlier surveillance scans (approximately 5-6 months) will be recorded descriptively but will not be included in the primary endpoint analysis.

Trial sites (1)

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