Esophageal Cancer
Conditions
Keywords
Esophagectomy, Enhanced Recovery after Surgery (ERAS), Robot-assisted minimally invasive esophagectomy (RAMIE)
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.
Interventions
PROCEDUREEarly removal of chest drain
Chest drains are removed 3 hours after the end of surgery in absence of contraindications in arm A.
PROCEDUREChest drain
The chest drains in arm B are removed during the further postoperative course according to standard algorithm.
Sponsors
German Cancer Research Center
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled multicentric trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | Day 2 after surgery | Postoperative pain according to a numeric rating scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Mean postoperative pain | Day 4 after surgery | Postoperative pain according to a numeric rating scale |
| 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 |
| 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 |
Countries
Germany
Outcome results
None listed