Fluid Balance During Surgery for Ovarian Cancer

Fluid Therapy Clinical Trial

Official title:

Intraoperative Fluid Balance During Cytoreductive Surgery for Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03006939
• Other study ID #: FBO
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2016
• Last updated: December 29, 2016
• Start date: December 2016
• Est. completion date: December 2022

Study information

• Verified date: December 2016
• Source: University Hospital, Bonn
• Contact: Martin Soehle, MD, PhD
• Phone: 0049-228-287-
• Email: martin.soehle[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Extensive tumour debulking challenges both surgeon and anaesthesiologist but promotes survival in late-stage ovarian cancer patients. Little is known about the intraoperative fluid balance and its impact on morbidity and mortality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients scheduled for cytoreductive surgery in ovarian cancer

Exclusion Criteria:

• Age < 18 years

• unability to give consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fluid Therapy
• Ovarian Neoplasm
• Ovarian Neoplasms

Intervention

Procedure:
• Cytoreductive surgery
Cytoreductive surgery in terms of tumor debulking is performed in order to promote survival

Locations

Country	Name	City	State
Germany	Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fluid balance	intraoperative fluid balance is determined by the difference between fluid intake and outtake	at the end of surgery	No
Secondary	mechanical ventilation	Duration of mechanical ventilation, starting from endotracheal intubation until extubation	at the timepoint of extubation	No
Secondary	mortality	long-term mortality after surgery	5 years	No