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Drainless Robot-assisted Minimally Invasive Esophagectomy (RESPECT)

T

Technische Universität Dresden

Status

Terminated

Conditions

Esophageal Cancer

Treatments

Procedure: Chest drain
Procedure: Early removal of chest drain

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49 participants in 2 patient groups

A - Early removal of chest drain
Experimental group
Treatment:
Procedure: Early removal of chest drain
B - Control
Other group
Treatment:
Procedure: Chest drain

Trial contacts and locations

1

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Central trial contact

Korn, Dr. rer. nat.

Data sourced from clinicaltrials.gov

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