Oesphageal Cancer, Para-conduit Hernia
Conditions
Keywords
Robotic Oesophagectomy, Robot-Assisted Surgery, Hiatal Closure, Omentopexy, Para-conduit Hernia, Minimally Invasive Oesophagectomy, Upper Gastrointestinal Surgery, Dysphagia, Edinburgh Dysphagia Score
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.
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.
Interventions
PROCEDUREStandard Hiatal Management
Robotic oesophagectomy performed with no hiatal closure or partial hiatal closure according to standard surgical practice.
PROCEDUREHiatal Closure With Omentopexy and Left Crus Fixation
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.
Sponsors
Royal College of Surgeons, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to treatment allocation. Surgeons cannot be blinded due to the intraoperative nature of the intervention. Data analysts and those assessing questionnaire outcomes will be blinded to allocation during analysis where feasible.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Para-conduit Hernia | 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
| Measure | Time frame | Description |
|---|---|---|
| Dysphagia Severity (Edinburgh Dysphagia Score) | Baseline and up to 12 months postoperatively | Dysphagia severity measured using the Edinburgh Dysphagia Score (EDS) during scheduled postoperative follow-up visits. |
| Patient-Reported Outcomes (Quality of Life Measures) | 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. |
| 30-Day Postoperative Morbidity | 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. |
Countries
Ireland
Contacts
CONTACTProf Jarlath Bolger
Outcome results
None listed