RESPECT: Drainless Robot-assisted Minimally Invasive Esophagectomy
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A - Early removal of chest drain
|
Procedure: Early removal of chest drain
Chest drains are removed 3 hours after the end of surgery in absence of contraindications in arm A.
|
| Other: B - Control
|
Procedure: Chest drain
The chest drains in arm B are removed during the further postoperative course according to standard algorithm.
|
Outcome Measures
Primary Outcome Measures
- Postoperative pain [Day 2 after surgery]
Postoperative pain according to a numeric rating scale
Secondary Outcome Measures
- Mean postoperative pain [Day 4 after surgery]
Postoperative pain according to a numeric rating scale
- Additional analgesic drug use [Day 4 after surgery]
opioids [mg], non-opioids [mg]
- Postoperative mobilization [Day 7 after surgery]
steps per day as measured with an activity tracker
- Postoperative morbidity [Through hospital stay, an average of 14 days]
The postoperative morbidity of all patients is assessed with the comprehensive complication index based on Clavien Dindo classification from postoperative day 1 until day of discharge
- Postoperative mortality [Through hospital stay, an average of 14 days]
The postoperative mortality of all patients is assessed between operation date and date of death of any cause during hospital stay
- Daily postoperative pain [Day 7 after surgery]
Postoperative pain according to a numeric rating scale measured daily from postoperative day 1-7
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients scheduled for elective RAMIE for esophageal cancer with intrathoracic esophagogastrostomy (Ivor-Lewis)
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American Society of Anesthesiologists (ASA) score ≤ III
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Eastern Cooperative of Oncology Group (ECOG) status ≤ II
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Patient suitable for both surgical techniques
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Ability of subject to understand character and individual consequences of the clinical trial
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Written informed consent
Exclusion Criteria:
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Open esophagectomy (either abdominal or during the thoracic part)
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Emergency operations
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ASA IV
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ECOG > II
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Chronic pain syndromes requiring routine analgesics
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Simultaneous lung resection
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Presence of contraindications to the use of epidural anesthesia (e.g. coagulopathies, anticoagulation or allergies)
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Participation in an interventional trial, which interferes with the outcome
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Impaired mental state
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden | Dresden | Saxony | Germany | 01307 |
Sponsors and Collaborators
- Technische Universität Dresden
- German Cancer Research Center
Investigators
- Principal Investigator: Johanna Kirchberg, Dr. med., Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VTG-11