Perioperative Assessment of Right Ventricular Function and Venous Return in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery (Gyn Right) - Pilot Study

Study Overview
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Brief Summary
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In this prospective, observational study the investigators assess the perioperative course of right ventricular function in combination with the venous return in patients undergoing major non-cardiac surgery. The study aims to investigate if patients undergoing major non-cardiac surgery develop an impairment of right ventricular function and/or venous return. Furthermore, the study evaluates if an impairment of right ventricular function and/or venous return is associated to left ventricular function, arterial side of the circulation and to postoperative clinical outcome.

Official Title
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Perioperative Assessment of Right Ventricular Function and Venous Return in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery (GynRight) - Pilot Study

Conditions
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Right Ventricular Function and Venous Return

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Offered patient information and written informed consent Female patients aged greater than or equal to 18 years for cytoreductive surgery of a primary epithelial ovarian tumour Patient Group 1: Female patients with > 500 ml ascites in the preoperative sonographic examination Patient group 2: Female patients aged > 70 years and at least one of the following secondary diagnoses: Status Post stent placement due to coronary heart disease respectively Status Post-myocardial infarction existing arterial Hypertension for more than 5 years chronic heart failure (New York Heart Association (NYHA) class II-III) peripheral arterial disease 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 Advanced disease of the oesophagus or upper respiratory tract at the beginning of hospitalization Operation in the area of the oesophagus or nasopharynx within the last two months before participation in the study 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female cancer patients with ascites<br>Primary epithelial ovarian female cancer patients with ascites (> 500 ml ascites in the preoperative sonographic examination) | |
| Female cancer patients aged > 70 years<br>Primary epithelial ovarian female cancer patients aged > 70 years with at least one of the following secondary diagnoses: Status Post stent placement due to coronary heart disease respectively Status Post-myocardial infarction existing arterial Hypertension for more than 5 years chronic heart failure (New York Heart Association (NYHA) class II-III) peripheral arterial disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricular function | Right ventricular function will be measured perioperatively by a combination of right ventricular stroke volume, tricuspid annular plane systolic excursion (TAPSE), hepatic venous blood flow, variations in diameter of vena cavae, and right ventricle/left ventricle-ratio. | Up to the first postoperative day | 
| Venous return | Venous return will be assessed perioperatively by venous return pressure gradient (dVR) | Up to the first postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variables of transthoracic and transesophageal echocardiography | Perioperative course of variables of transthoracic and transesophageal echocardiography | Up to the first postoperative day | 
| Venous return variables according to Guyton concept | Perioperative course of variables according to Guyton concept characterizing venous return | Up to the first postoperative day | 
| Hemodynamic variables | Hemodynamic variables are assessed by the anesthesia monitor and esophageal Doppler Monitor | Up to the third postoperative day | 
| Catecholamine administration | Catecholamine administration intra- und postoperative | Up to the third postoperative day | 
| Immunological parameter | Perioperative immunological (IL-6 und TNF-alpha) | Up to the third postoperative day | 
| Endothelial parameter | Perioperative endothelial Parameter (ICAM-1) | Up to the third postoperative day | 
| Microvascular function | Perioperative course of variables assessing microvascular function | Up to the first postoperative day | 
| Blood loss | Blood loss characteristics intra- und postoperative | Up to the third postoperative day | 
| Fluid balance | Fluid and volume administration and balance intra- und postoperative | Up to the third postoperative day | 
| Organ complications | Postoperative organ complications are classified according to Clavien - Dindo classification | Participants will be followed up until hospital discharge, an average of two weeks | 
| Postoperative pain | Postoperative pain will be measured by Numeric Rating Scale - Visualized (NRS-V), the Faces Pain Scale - Revised (FPS-R), the Behavioral Pain Scale (BPS) or the Behavioral Pain Scale for Non-Intubated (BPS-NI) | Up to the third postoperative day | 
| Hospital length of stay |  | Participants will be followed up until hospital discharge, an average of two weeks | 
| Intensive care unit length of stay |  | Participants will be followed up until intensive crae unit discharge, an average of two days | 
| Quality of life | Assessed with EQ-5D questionnaire | Baseline and hospital discharge with an expected average of 14 days | 
| Functional status | Measured by the Barthel activities of daily living (ADL) index and activities of daily living (IADL). | Baseline and hospital discharge with an expected average stay of 14 days |