Clinical trial · Observational
Perioperative Early Tiredness (Acute Fatigue) in Patients With Epithelial Ovarian Cancer
Association of Perioperative Early Tiredness (Acute Fatigue) With Hemodynamic, Immunologic, Endothelial, Metabolic, Gastrointestinal Measures and Complications in Patients With Epithelial Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In surgical patients early risk prediction of postoperative complications and organ dysfunctions is still an important clinical challenge whereas appropriate risk predictors are still missing. In this regard, fatigue is a complex phenomenon, is affected by many factors and has been shown to be associated with delayed return to normal activity after surgery. The investigators hypothesize that early tiredness (acute fatigue) assessed shortly after surgery is associated to postoperative complications and organ dysfunctions and might be used for risk stratification. Therefore, in this prospective, observational study the investigators introduce and evaluate a newly developed score to assess early fatigue during the perioperative period ("Acute Fatigue Score", AFS). The AFS and the Identity-Consequence Fatigue Scala will be used to assess early fatigue and perioperative time courses and inter-rater-variability will be evaluated. The rating of these two fatigue scores will be evaluated regarding the association with hemodynamic, immunologic, endothelial, metabolic, gastrointestinal measures as well as organ dysfunction and complications after surgery. Furthermore, hemodynamic, immunologic, endothelial, metabolic and gastrointestinal measures are investigated with respect to the intraoperative course and postoperative organ dysfunction and complications. In a subgroup of patients, patients will undergo specialized metabolic measures to investigate mitochondrial dysfunction during the perioperative period.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biosignals | — | UNRESOLVED | — |
| Electrical Cardiometry | — | UNRESOLVED | — |
| Mitochondrial Dysfunction | — | UNRESOLVED | — |
| Nutrition | — | UNRESOLVED | — |
| Perioperative Early Tiredness (Acute Fatigue) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Patients with epithelial ovarian cancer (EOC)
- description
- Patients undergoing cytoreductive surgery due to epithelial ovarian cancer
- label
- Subgroup - Metabolomics in EOC patients without ascites
- description
- In a subgroup (n=10), patients without preoperative ascites will undergo extended metabolic measures to investigate mitochondrial dysfunction during the preoperative period.
- label
- Subgroup - Metabolomics in EOC patients with ascites >500ml
- description
- In a subgroup (n=10), patients with preoperative ascites \>500ml will undergo extended metabolic measures to investigate mitochondrial dysfunction during the preoperative period.
Primary outcomes (1)
- measure
- Acute Fatigue Score (AFS)
- timeFrame
- 1 hour after the end of anaesthesia
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with epithelial ovarian cancer scheduled for cytoreductive surgery at the Department of Gynecology at Campus Virchow - Klinikum, Charité - University Berlin * Offered patient information and written informed consent Exclusion Criteria: * Patients aged less than 18 years * Persons without the capacity to consent * Inability of German language use * Lacking willingness to save and hand out data within the study * Accommodation in an institution due to an official or judicial order * (Unclear) history of alcohol or substances disabuse * Coworker of the Charité * Known Myopathy * Neurological or psychiatric disease at the beginning of hospitalization * CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospitalization * American Society of Anesthesiologists (ASA) classification greater than IV * Renal insufficiency (dependency of haemodialysis) at the beginning of hospitalization * Pulmonary oedema in thorax x-ray at the beginning of hospitalization * History of intracranial hemorrhage within one year before participation in the study * Conditions following venous thrombosis within the last three years before study inclusion * Known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions * Diabetes mellitus with signs of severe neuropathy * Known atrial fibrillation * Participation in an interventional clinical trial during the study period; exception: assignment to adjuvant therapy study during this study is allowed.
References
Publications (0)
Data not yet available