Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:32 PM
Study NCT ID:
NCT07426835
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Royal College of Surgeons, Ireland
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHARO
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: