NCT03006939

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 30, 2016

Status Verified

December 1, 2016

Enrollment Period

3 years

First QC Date

December 14, 2016

Last Update Submit

December 29, 2016

Conditions

Ovarian NeoplasmFluid Therapy

Outcome Measures

Primary Outcomes (1)

  • fluid balance

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

    at the end of surgery

Secondary Outcomes (2)

  • mechanical ventilation

    at the timepoint of extubation

  • mortality

    5 years

Interventions

Cytoreductive surgeryPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ovarian cancer

You may qualify if:

  • patients scheduled for cytoreductive surgery in ovarian cancer

You may not qualify if:

  • Age \< 18 years
  • unability to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn

Bonn, 53105, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples are retained to determine the coagulation status as well as the albumine concentration

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Martin Soehle, MD, PhD

    University Clinic Bonn

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Soehle, MD, PhD

CONTACT

0049-228-287-martin.soehle@ukb.uni-bonn.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice head of the department

Study Record Dates

First Submitted

December 14, 2016

First Posted

December 30, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2022

Last Updated

December 30, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)