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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of Para-conduit Hernia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Evidence of distant metastatic disease
- •Not suitable for robotic oesophagectomy
- •Inability to provide informed consent
研究组 & 干预措施
Standard Hiatal Management
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.
干预措施: Standard Hiatal Management (Procedure)
Hiatal Closure With Omentopexy and Left Crus Fixation
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.
干预措施: Hiatal Closure With Omentopexy and Left Crus Fixation (Procedure)
结局指标
主要结局
Incidence of Para-conduit Hernia
时间窗: 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.
次要结局
- Dysphagia Severity (Edinburgh Dysphagia Score)(Baseline and up to 12 months postoperatively)
- Patient-Reported Outcomes (Quality of Life Measures)(Baseline and up to 12 months postoperatively)
- 30-Day Postoperative Morbidity(Within 30 days postoperatively)