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NCT Number: NCT07426835

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

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.

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Key information

Conditions

Oesphageal Cancer Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Para-conduit Hernia Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beaumont RCSI Cancer Centre

Dublin, Beaumont, D09V2N0, Ireland

Location status: Recruiting

Location contact

Aisling Hegarty, PhD

CONTACT

[email protected]

018093000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Hiatal Management

Procedure

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

Hiatal Closure With Omentopexy and Left Crus Fixation

Procedure

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Prof Jarlath Bolger

CONTACT

[email protected]

+35318093000

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Registry information

Acronym: PHARO

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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