Fluid Balance During Surgery for Ovarian Cancer

• Sponsor: University Hospital, Bonn (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03006939
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 72
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Neoplasm; Fluid Therapy	Procedure: Cytoreductive surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Intraoperative Fluid Balance During Cytoreductive Surgery for Ovarian Cancer
• Study Start Date: Dec 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2022

Outcome Measures

Primary Outcome Measures

1. fluid balance [at the end of surgery]

   intraoperative fluid balance is determined by the difference between fluid intake and outtake

Secondary Outcome Measures

1. mechanical ventilation [at the timepoint of extubation]

   Duration of mechanical ventilation, starting from endotracheal intubation until extubation

2. mortality [5 years]

   long-term mortality after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients scheduled for cytoreductive surgery in ovarian cancer

Exclusion Criteria:

• Age < 18 years

• unability to give consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn	Bonn		Germany	53105

Sponsors and Collaborators

• University Hospital, Bonn

Investigators

• Principal Investigator: Martin Soehle, MD, PhD, University Clinic Bonn

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Martin Soehle, Vice head of the department, University Hospital, Bonn
• ClinicalTrials.gov Identifier: NCT03006939
• Other Study ID Numbers: FBO
• First Posted: Dec 30, 2016
• Last Update Posted: Dec 30, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Ovarian Neoplasms

Study Results

No Results Posted as of Dec 30, 2016