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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Hiatal Management, Hiatal Closure With Omentopexy and Left Crus Fixation.
- Who it may be relevant to
- Registry conditions: Oesphageal Cancer, Para-conduit Hernia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Background
Para-conduit hernia is increasingly recognised following minimally invasive and robotic oesophagectomy. The incidence appears higher than in open surgery and may be associated with extensive mediastinal dissection and widened hiatus. Clinical presentation ranges from asymptomatic radiological detection to incarceration requiring urgent surgical repair.
Robotic-assisted oesophagectomy offers technical advantages, including improved dexterity and visualisation. However, there is no consensus on whether routine hiatal closure reduces postoperative hernia formation.
Study Design
This is a prospective, single-centre, single-blinded, pilot randomised controlled trial conducted at Beaumont Hospital.
Participants will be randomised in a 1:1 ratio to:
Standard hiatal management (control)
Hiatal closure with omentopexy and thoracic fixation (intervention)
Participants will be blinded to allocation. Surgeons cannot be blinded due to the nature of the intraoperative intervention. Outcome assessors and data analysts will be blinded where feasible.
Intervention
Control Arm:
Standard approach of no hiatal closure or partial closure during robotic oesophagectomy.
Intervention Arm:
Hiatal closure followed by omentopexy and thoracic fixation of the left crus. A standardised operative video will be circulated to ensure technique consistency.
Follow-Up
Patients undergo routine postoperative surveillance including CT imaging at approximately 5-6 months and 12 months. The 12-month CT scan will serve as the reference timepoint for primary endpoint analysis.
Sample Size
This pilot study will enrol 40 patients (20 per arm). Findings will inform design and power calculation for a future multi-centre phase II study.
Interventions
- Procedure Standard Hiatal Management
Robotic oesophagectomy performed with no hiatal closure or partial hiatal closure according to standard surgical practice. - Procedure 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.
Primary outcome measures
- Incidence of Para-conduit Hernia [Time frame: Up to 12 months postoperatively (reference time point: 12-month surveillance CT scan)]
Secondary outcome measures (3)
- Dysphagia Severity (Edinburgh Dysphagia Score) [Time frame: Baseline and up to 12 months postoperatively]
- Patient-Reported Outcomes (Quality of Life Measures) [Time frame: Baseline and up to 12 months postoperatively]
- 30-Day Postoperative Morbidity [Time frame: Within 30 days postoperatively]
Eligibility criteria
Inclusion criteria
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 criteria
Evidence of distant metastatic disease
Not suitable for robotic oesophagectomy
Inability to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Ireland · 1 center
- Beaumont RCSI Cancer Centre — Dublin
Identifiers
NCT: NCT07426835 · 25-60