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

Charité University Medicine Berlin

Status: Withdrawn

Conditions: Right Ventricular Function and Venous Return

Study type: Observational

Funder types: Other

Identifiers

NCT02291276

GynRight

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

  1. Patient Group 1: Female patients with > 500 ml ascites in the preoperative sonographic examination

  2. 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.

Trial design

0 participants in 2 patient groups

Female cancer patients with ascites

Description:

Primary epithelial ovarian female cancer patients with ascites (\> 500 ml ascites in the preoperative sonographic examination)

Female cancer patients aged > 70 years

Description:

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