Perioperative Early Tiredness (Acute Fatigue) in Patients With Epithelial Ovarian Cancer (PERISCOPE)

Aarne Feldheiser

Status: Completed

Conditions: Perioperative Early Tiredness (Acute Fatigue); Mitochondrial Dysfunction; Biosignals; Nutrition; Electrical Cardiometry

Study type: Observational

Funder types: Other

Identifiers

NCT03131102

PERISCOPE

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 3 patient groups

Patients with epithelial ovarian cancer (EOC)

Description:

Patients undergoing cytoreductive surgery due to epithelial ovarian cancer

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.

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.