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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

Domain

Description

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’.