Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oesphageal Cancer | — | UNRESOLVED | — |
| Para-conduit Hernia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hiatal Closure With Omentopexy and Left Crus Fixation | Procedure | — | UNRESOLVED |
| Standard Hiatal Management | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Hiatal Management
- description
- 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.
- interventionNames
- Procedure: Standard Hiatal Management
- type
- EXPERIMENTAL
- label
- Hiatal Closure With Omentopexy and Left Crus Fixation
- description
- 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.
- interventionNames
- Procedure: Hiatal Closure With Omentopexy and Left Crus Fixation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available