Closing the hiatus with omentopexy and left-crus fixation during robotic oesophagectomy to prevent para-conduit hernia
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
NA · Royal College of Surgeons, Ireland · NCT07426835
This study will test whether routinely closing the hiatus with omentopexy and fixing the left crus during robotic oesophagectomy reduces para-conduit hernia in adults having surgery for non-metastatic oesophageal cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal College of Surgeons, Ireland (other) |
| Locations | 1 site (Dublin, Beaumont) |
| Trial ID | NCT07426835 on ClinicalTrials.gov |
What this trial studies
The PHARO trial is a single-centre, single-blinded, randomised pilot comparing standard hiatal management (no or partial closure) with hiatal closure plus omentopexy and thoracic fixation of the left crus in patients undergoing robotic oesophagectomy at Beaumont RCSI Cancer Centre. Eligible adults with non-metastatic oesophageal cancer are randomised 1:1 and participants are blinded to allocation while surgeons are not. Outcomes include routine clinical follow-up and CT imaging at about 5–6 and 12 months to detect para-conduit hernia, with outcome assessors blinded where feasible. A standardised operative video is used to ensure consistent technique across intervention cases.
Who should consider this trial
Good fit: Adults (≥18 years) with non-metastatic oesophageal cancer planned for curative-intent robotic oesophagectomy who can provide informed consent are the intended participants.
Not a fit: Patients with distant metastatic disease, those not suitable for robotic oesophagectomy, or those unable to give informed consent would not be eligible and are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, routine hiatal closure with omentopexy and left-crus fixation could lower the rate of para-conduit hernias and reduce emergency reoperations after robotic oesophagectomy.
How similar studies have performed: Observational series and surgeon experience suggest hiatal closure may reduce para-conduit hernia, but randomised trial evidence is limited and this specific combined technique is not yet proven in RCTs.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dublin, Beaumont
- Beaumont RCSI Cancer Centre — Dublin, Beaumont, Ireland (RECRUITING)
Study contacts
- Study coordinator: Prof Jarlath Bolger
- Email: jarbolger@rcsi.com
- Phone: +35318093000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oesphageal Cancer, Para-conduit Hernia, Robotic Oesophagectomy, Robot-Assisted Surgery, Hiatal Closure, Omentopexy, Minimally Invasive Oesophagectomy, Upper Gastrointestinal Surgery