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Drainless Robot-assisted Minimally Invasive Esophagectomy

Recruiting
18 years of age
Both
Phase N/A

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Overview

The aim of this study is the evaluation of two different chest drain management strategies in patients undergoing robot-assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer with regard to perioperative complications until discharge.The primary objective of the study is to investigate whether the intensity of postoperative pain can be significantly reduced by avoiding thoracic drains after RAMIE. We assume that this will influence secondary endpoints such as early recovery and length of hospital stay.

Eligibility

Inclusion Criteria:

  • Patients scheduled for elective RAMIE for esophageal cancer with intrathoracic esophagogastrostomy (Ivor-Lewis)
  • American Society of Anesthesiologists (ASA) score ≤ III
  • Eastern Cooperative of Oncology Group (ECOG) status ≤ II
  • Patient suitable for both surgical techniques
  • Ability of subject to understand character and individual consequences of the clinical trial
  • Written informed consent

Exclusion Criteria:

  • Open esophagectomy (either abdominal or during the thoracic part)
  • Emergency operations
  • ASA IV
  • ECOG > II
  • Chronic pain syndromes requiring routine analgesics
  • Simultaneous lung resection
  • Presence of contraindications to the use of epidural anesthesia (e.g. coagulopathies, anticoagulation or allergies)
  • Participation in an interventional trial, which interferes with the outcome
  • Impaired mental state

Study details

Esophageal Cancer

NCT05553795

Technische Universität Dresden

26 January 2024

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