Drainless Robot-assisted Minimally Invasive Esophagectomy

Study Overview
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Brief Summary
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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.

Official Title
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Drainless Robot-assisted Minimally Invasive Esophagectomy

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Procedure: Early removal of chest drain
* Procedure: Chest drain


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled multicentric trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - Early removal of chest drain<br> | Procedure: Early removal of chest drain<br>* Chest drains are removed 3 hours after the end of surgery in absence of contraindications in arm A.<br>|
| Other: B - Control<br> | Procedure: Chest drain<br>* The chest drains in arm B are removed during the further postoperative course according to standard algorithm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain according to a numeric rating scale | Day 2 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean postoperative pain | Postoperative pain according to a numeric rating scale | Day 4 after surgery | 
| Additional analgesic drug use | opioids [mg], non-opioids [mg] | Day 4 after surgery | 
| Postoperative mobilization | steps per day as measured with an activity tracker | Day 7 after surgery | 
| Postoperative morbidity | 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 | Through hospital stay, an average of 14 days | 
| Postoperative mortality | The postoperative mortality of all patients is assessed between operation date and date of death of any cause during hospital stay | Through hospital stay, an average of 14 days | 
| Daily postoperative pain | Postoperative pain according to a numeric rating scale measured daily from postoperative day 1-7 | Day 7 after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagectomy, Enhanced Recovery after Surgery (ERAS), Robot-assisted minimally invasive esophagectomy (RAMIE)