Fluid Balance During Surgery for Ovarian Cancer | NCT03006939

Studies
Fluid Balance During Surgery for Ovarian Cancer

NCT03006939

Sponsor

University Hospital, Bonn

Status

Unknown status

Last Update Posted

Dec 30, 2016Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Ovarian Neoplasm
Fluid Therapy

Interventions

Cytoreductive surgery

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Dec 14, 2016

First Submission Date that Met QC Criteria

Dec 29, 2016

First Posted Date

Dec 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2016

Last Update Posted Date

Dec 30, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Martin Soehle, Vice head of the department, University Hospital, BonnPrincipal Investigator

Lead Sponsor

University Hospital, BonnOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytoreductive surgery	Procedure	Cytoreductive surgery in terms of tumor debulking is performed in order to promote survival

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fluid balance	intraoperative fluid balance is determined by the difference between fluid intake and outtake	at the end of surgery

Secondary Outcomes

Measure	Description	Time Frame
mechanical ventilation	Duration of mechanical ventilation, starting from endotracheal intubation until extubation	at the timepoint of extubation
mortality	long-term mortality after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients scheduled for cytoreductive surgery in ovarian cancer

Exclusion Criteria:

Age < 18 years
unability to give consent

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with ovarian cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Martin Soehle, MD, PhD	Contact	0049-228-287-	11378	martin.soehle@ukb.uni-bonn.de

Overall Officials

Name	Affiliation	Role
Martin Soehle, MD, PhD	University Clinic Bonn	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn	Recruiting	Bonn		53105	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D065426	Cytoreduction Surgical Procedures

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided