Ovarian NeoplasmNCT03006939
Fluid Balance During Surgery for Ovarian Cancer
An observational study of Ovarian Neoplasm and Fluid Therapy, run by University Hospital, Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasm, Fluid Therapy
- What is being tested?
- Cytoreductive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2016to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ovarian cancer
Who may be able to join
- patients scheduled for cytoreductive surgery in ovarian cancer
Who cannot join
- Age < 18 years
- unability to give consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
Bonn, 53105
Martin Soehle, MD, PhD, ++49-228-287 ext. 11378, martin.soehle@ukb.uni-bonn.de
Claudia Neumann, MD, ++49-228-287 ext. 11378, claudia.neumann@ukb.uni-bonn.de
About this study
Official title: Intraoperative Fluid Balance During Cytoreductive Surgery for Ovarian Cancer
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.
- Conditions
- Ovarian Neoplasm, Fluid Therapy
- Being tested
- Cytoreductive surgery
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive surgeryProcedure or surgery
Cytoreductive surgery in terms of tumor debulking is performed in order to promote survival
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid balance
intraoperative fluid balance is determined by the difference between fluid intake and outtake
Measured: at the end of surgery
Secondary outcomes (2)
mechanical ventilation
Duration of mechanical ventilation, starting from endotracheal intubation until extubation
Measured: at the timepoint of extubation
mortality
long-term mortality after surgery
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Soehle, University Hospital, Bonn
- Investigators
- Martin Soehle, MD, PhD, Principal investigator, University Clinic Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006939
- Sponsor's protocol ID
- FBO
- Status last verified
- Dec 2016
- First submitted
- 14 Dec 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Fluid Balance During Cytoreductive Surgery for Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03006939
- Acronym / sponsor ID
- FBO
- Conditions
- Ovarian Neoplasm, Fluid Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ovarian cancer
Key inclusion criteria (1 listed)
- patients scheduled for cytoreductive surgery in ovarian cancer
Key exclusion criteria (2 listed)
- Age < 18 years
- unability to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytoreductive surgeryCytoreductive surgery in terms of tumor debulking is performed in order to promote survival | Procedure or surgery | – |
Primary outcome
fluid balance
Time frame: at the end of surgery
intraoperative fluid balance is determined by the difference between fluid intake and outtake
2 secondary outcomes
mechanical ventilation
Time frame: at the timepoint of extubation
mortality
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Soehle, MD, PhD principal investigator
University Clinic Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasm and Fluid Therapy, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Soehle, MD, PhD (0049-228-287- ext. 11378, martin.soehle@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluid balance (time frame: at the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2016.