C15.5 C16.0
Conditions
Interventions
Group 1: Transabdominal chest drainage after Iwor-Lewis in prospective recruited patients
Group 2: Intercostal chest drainage after Iwor-Lewis from a historical cohort
Sponsors
Universitätsklinikum Ulm, Klinik für Allgemein- und Viszeralchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • elective RAMIE 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
Exclusion criteria: emergency surgery, ASA IV, ECOG > II, chronic pain syndromes requiring routine analgesic therapy, participation in an interventional trial that affects the outcome, and impaired mental state that precludes admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of postoperative pain according to NRS at postoperative day three | — |
Secondary
| Measure | Time frame |
|---|---|
| • Postoperative intervention rate (CT/ultrasound-guided punctures of an intra-abdominal collections • Reoperation rate • Surgery – specific morbidity (within the hospital stay and 30 days postoperatively) o Postoperative complications classified according to the Clavien-Dindo classification. • Mortality (within the hospital stay and 30 days postoperatively) • Length of IMC/ICU stay. • Length of hospital stay. • Additional interventional therapies required (e.g. endoscopic procedures, insertion of a gastric tube or a feeding tube | — |
Countries
Germany
Contacts
Public ContactBenjamin Müssle
Universitätsklinikum Ulm, Klinik für Allgemein- und Viszeralchirurgie
Outcome results
None listed