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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Standard Hiatal Management
  Robotic oesophagectomy performed with no hiatal closure or partial hiatal closure according to standard surgical practice.
• Процедура Hiatal 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.

Первичные конечные точки

• Incidence of Para-conduit Hernia [Срок оценки: Up to 12 months postoperatively (reference time point: 12-month surveillance CT scan)]

Вторичные конечные точки (3)

• Dysphagia Severity (Edinburgh Dysphagia Score) [Срок оценки: Baseline and up to 12 months postoperatively]
• Patient-Reported Outcomes (Quality of Life Measures) [Срок оценки: Baseline and up to 12 months postoperatively]
• 30-Day Postoperative Morbidity [Срок оценки: Within 30 days postoperatively]

Критерии участия

Критерии включения

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

Критерии исключения

Evidence of distant metastatic disease

Not suitable for robotic oesophagectomy

Inability to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Ирландия · 1 центр

• Beaumont RCSI Cancer Centre — Dublin

Идентификаторы

NCT: NCT07426835 · 25-60

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗