confirmed or suspected gastrointestinal malignancies
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Major abdominal surgery for confirmed or suspected gastrointestinal malignancies • Age equal or greater than 18 years • Written informed consent
Exclusion criteria
Exclusion criteria: • American Society of Anesthesiologist (ASA) classification = 4 • Planned re-operation within 30 days after index operation • Mental impairment that prevents an understanding of nature, type and scope of the research project • Allergies to used oils (rosemary oil, citrus oil, solum oil, melissa oil), ingredients of them or hypersensitivity to skincare products • Acute skin disorders at the abdomen or legs • Emergency Operations • Pregnancy or breastfeeding • Participation in another interventional trial with interference on intervention and/or outcome of this trial • Expected lack of compliance • Insufficient German language skills
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Time to functional recovery (TFR) Time (days) to functional recovery until discharge, defined as all of the following: • Independent mobility or mobility at the preoperative level (Postoperative Mobility Scale) • Sufficient pain control with oral analgesia only (Numeric Rating Scale = 3) • Tolerance of solid food • No intravenous fluid administration and • No signs of infection A patient is deemed to have recovered total functionally when all of the aforementioned criteria are met. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Clinical Outcomes: Postoperative Milestones (free oral fluids, removal of indwelling urinary catheter, first flatus, first stool), intensity of analgesic treatment, length of hospital stay, postoperative complications, surgical revision, invasive re-intervention (radiological/ endoscopic), hospital readmission, collected up to POD 90 • Patient-Reported Outcomes: Quality of recovery (QoR-15), quality of life (EORTC QLQ-C30), evaluation of integrative nursing interventions (mod. ZUF-8), satisfaction with the hospital stay (NRS), use of and interest in complementary and integrative medicine, collected at inclusion, partly at POD 3, 5, 7, at discharge, and up to POD 90 • Integrative Nursing Intervention: Implementation, adherence, and any adverse reactions, recorded after each session | — |
Countries
Germany
Contacts
Universitätsklinikum Ulm, Klinik für Allgemein- und Viszeralchirurgie, Fachbereich Integrative Medizin