Oesphageal CancerPHARONCT07426835
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
A study testing Standard Hiatal Management and Hiatal Closure With Omentopexy and Left Crus Fixation in people with Oesphageal Cancer and Para-conduit Hernia, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesphageal Cancer, Para-conduit Hernia
- What is being tested?
- Standard Hiatal Management and Hiatal Closure With Omentopexy and Left Crus Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 19 Dec 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Evidence of distant metastatic disease
- Not suitable for robotic oesophagectomy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Beaumont RCSI Cancer Centre
Dublin, Beaumont, D09V2N0
Aisling Hegarty, PhD, 018093000, Aislinghegarty@rcsi.ie
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Oesphageal Cancer, Para-conduit Hernia
- Being tested
- Standard Hiatal Management, Hiatal Closure With Omentopexy and Left Crus Fixation
- Keywords
- Robotic Oesophagectomy, Robot-Assisted Surgery, Hiatal Closure, Omentopexy, Para-conduit Hernia, Minimally Invasive Oesophagectomy, Upper Gastrointestinal Surgery, Dysphagia, Edinburgh Dysphagia Score
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Hiatal ManagementProcedure or surgery
Robotic oesophagectomy performed with no hiatal closure or partial hiatal closure according to standard surgical practice.
Hiatal Closure With Omentopexy and Left Crus FixationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Standard Hiatal Management | Active comparator | 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. Receives: Procedure: Standard Hiatal Management |
| Hiatal Closure With Omentopexy and Left Crus Fixation | Experimental | 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. Receives: Procedure: Hiatal Closure With Omentopexy and Left Crus Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Para-conduit Hernia
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.
Measured: Up to 12 months postoperatively (reference time point: 12-month surveillance CT scan)
Secondary outcomes (3)
Dysphagia Severity (Edinburgh Dysphagia Score)
Dysphagia severity measured using the Edinburgh Dysphagia Score (EDS) during scheduled postoperative follow-up visits.
Measured: Baseline and up to 12 months postoperatively
Patient-Reported Outcomes (Quality of Life Measures)
Change in patient-reported quality-of-life measures assessing physical, psychosocial, and functional well-being using validated questionnaires administered during follow-up.
Measured: Baseline and up to 12 months postoperatively
30-Day Postoperative Morbidity
Incidence of clinically relevant postoperative complications occurring within 30 days of surgery, including bleeding, intensive care unit readmission, lower respiratory tract infection, and reoperation.
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start19 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesphageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-centre, prospective, single-blinded, pilot randomised controlled trial. Eligible patients undergoing robotic oesophagectomy for non-metastatic oesophageal cancer will be randomised in a 1:1 ratio to either standard hiatal management (no closure or partial closure) or hiatal closure with omentopexy and thoracic fixation of the left crus. Randomisation will be performed using an online randomisation system with sequential study numbers assigned. Participants will be blinded to allocation. Follow-up will include routine clinical and radiological surveillance up to 12 months postoperatively.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426835
- Sponsor's protocol ID
- 25-60
- Acronym
- PHARO
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07426835
- Acronym / sponsor ID
- PHARO / 25-60
- Conditions
- Oesphageal Cancer, Para-conduit Hernia
- Keywords
- Robotic Oesophagectomy, Robot-Assisted Surgery, Hiatal Closure, Omentopexy, Para-conduit Hernia, Minimally Invasive Oesophagectomy, Upper Gastrointestinal Surgery, Dysphagia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a single-centre, prospective, single-blinded, pilot randomised controlled trial. Eligible patients undergoing robotic oesophagectomy for non-metastatic oesophageal cancer will be randomised in a 1:1 ratio to either standard hiatal management (no closure or partial closure) or hiatal closure with omentopexy and thoracic fixation of the left crus. Randomisation will be performed using an online randomisation system with sequential study numbers assigned. Participants will be blinded to allocation. Follow-up will include routine clinical and radiological surveillance up to 12 months postoperatively.
| Arm | Type | Receives |
|---|---|---|
| Standard Hiatal Management | Active comparator | Procedure: Standard Hiatal ManagementParticipants 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. |
| Hiatal Closure With Omentopexy and Left Crus Fixation | Experimental | Procedure: Hiatal Closure With Omentopexy and Left Crus FixationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Evidence of distant metastatic disease
- Not suitable for robotic oesophagectomy
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Hiatal ManagementRobotic oesophagectomy performed with no hiatal closure or partial hiatal closure according to standard surgical practice. | Procedure or surgery | Standard Hiatal Management |
| Hiatal Closure With Omentopexy and Left Crus FixationRobotic 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. | Procedure or surgery | Hiatal Closure With Omentopexy and Left Crus Fixation |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Oesphageal Cancer
Recruiting
MCT Enteral Feeding to Reduce Chyle Leak After Oesophagectomy
Oesphageal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Hiatal Management and Hiatal Closure With Omentopexy and Left Crus Fixation in people with Oesphageal Cancer and Para-conduit Hernia, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof Jarlath Bolger (+35318093000, jarbolger@rcsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Para-conduit Hernia (time frame: Up to 12 months postoperatively (reference time point: 12-month surveillance CT scan)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.