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Table 1 Summary of TIME trial

From: A mixed methods case study investigating how randomised controlled trials (RCTs) are reported, understood and interpreted in practice

DomainDescription
Population• Patients with surgically resectable (cT1–3, N0–1, M0) squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic oesophagus or Siewert type 1 oesophago-gastric junction tumours
• Underwent neoadjuvant therapy
• Age ≥ 18 years and ≤ 75 years
• European Clinical Oncology Group performance status 0–2
Intervention• Minimally Invasive Oesophagectomy (MIO): supine laparoscopic gastric mobilisation and prone thoracoscopic procedure with either cervical or intra-thoracic anastomosis
Comparator• Open two- or three-phase oesophagectomy with cervical or intra-thoracic anastomosis
Outcome• 2-week and in-hospital pulmonary infection rates
Results• 59 patients had MIO and 56 patients underwent open surgery
• 9% vs 34% pulmonary infection rate (relative risk 0.30, 95% confidence interval 0.12–0.76, p = 0.005)
Conclusion• This ‘first randomised trial’ comparing MIO and open approach provided ‘evidence for the short-term benefits of minimally invasive oesophagectomy for patients with resectable oesophageal cancer’.
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