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NCT05553795 | Recruiting | Esophageal Cancer

Drainless Robot-assisted Minimally Invasive Esophagectomy
Sponsor:

Technical University Dresden

Brief Summary:

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.

Condition or disease

Esophageal Cancer

Intervention/treatment

Early removal of chest drain

Chest drain

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 72 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Drainless Robot-assisted Minimally Invasive Esophagectomy
Actual Study Start Date : April 19, 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : December 2024
Arm Intervention/treatment

Experimental: A - Early removal of chest drain

Procedure: Early removal of chest drain

Other: B - Control

Procedure: Chest drain
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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
Drainless Robot-assisted Minimally Invasive Esophagectomy

Location Details

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Drainless Robot-assisted Minimally Invasive Esophagectomy

How to Participate

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Locations

Recruiting

Germany, Saxony

Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden

Dresden, Saxony, Germany, 01307