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 (PHARO)

February 16, 2026 updated by: Royal College of Surgeons, Ireland

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ireland
    • Beaumont
      • Dublin, Beaumont, Ireland, D09V2N0
        • Recruiting
        • Beaumont RCSI Cancer Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Hiatal Management
Participants randomised to this group will undergo robotic oesophagectomy with standard hiatal management, consisting of no hiatal closure or partial hiatal closure according to current institutional practice. All other aspects of perioperative care and postoperative surveillance will follow standard clinical protocols.
Procedure: Standard Hiatal Management
Robotic oesophagectomy performed with no hiatal closure or partial hiatal closure according to standard surgical practice.
Experimental: Hiatal Closure With Omentopexy and Left Crus Fixation
Participants randomised to this group will undergo robotic oesophagectomy with complete hiatal closure followed by omentopexy and thoracic fixation of the left crus. A standardised operative technique will be used to ensure consistency across cases. Postoperative care and surveillance will follow standard clinical protocols.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Para-conduit Hernia
Time Frame: 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.
Up to 12 months postoperatively (reference time point: 12-month surveillance CT scan)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysphagia Severity (Edinburgh Dysphagia Score)
Time Frame: Baseline and up to 12 months postoperatively
Dysphagia severity measured using the Edinburgh Dysphagia Score (EDS) during scheduled postoperative follow-up visits.
Baseline and up to 12 months postoperatively
Patient-Reported Outcomes (Quality of Life Measures)
Time Frame: Baseline and up to 12 months postoperatively
Change in patient-reported quality-of-life measures assessing physical, psychosocial, and functional well-being using validated questionnaires administered during follow-up.
Baseline and up to 12 months postoperatively
30-Day Postoperative Morbidity
Time Frame: Within 30 days postoperatively
Incidence of clinically relevant postoperative complications occurring within 30 days of surgery, including bleeding, intensive care unit readmission, lower respiratory tract infection, and reoperation.
Within 30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-60

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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