Effect of Anesthetic Conditions on Stapling Thickness and Quality
NCT ID: NCT04191564
Last Updated: 2019-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
20 participants
INTERVENTIONAL
2020-03-31
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
low perfusion group means that
1. systolic blood pressure is kept below 100 mmHg from the first linear staple till the last by using a Clevidipine infusion to regulate the blood pressure accurate just below 100 mmHg for a short time while needed.
2. goal directed fluid therapy using 100 ml/h fluid intravenous and extra load of fluid if pulse pressure variation \> 20 %
3. increase intra abdominal pressure (IAP) up to 20 mmHg inly during stapling and return to minimum IAP needed to achieve 3 liter workspace.
The resected stomach is removed and analyzed outside the body before throwing away:
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
low perfusion
fluid restriction based on the goal directed fluid therapy is maintained during the whole case and a state of low perfusion is created by reducing the systolic blood pressure below 100 mmHg by vasoactive medications like cleviprex or nicardipine, by increasing positive end expiratory pressure (PEEP) and by a very short period of a high IAP of 20 mmHg only during firing.
low perfusion state
reduce SAP below 100 mmHg
normal perfusion
Perfusion pressure is maintained above 100 mmHg with free fluid loading iv and the lowest IAP possible during the whole procedure.
normal perfusion state
maintain SAP above 100 mmHg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
low perfusion state
reduce SAP below 100 mmHg
normal perfusion state
maintain SAP above 100 mmHg
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* liver, renal, cardiac or lung disease with limited function
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AZ Sint-Jan AV
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jan Mulier
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jan Paul Mulier
Role: PRINCIPAL_INVESTIGATOR
AZSint Jan AV
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Azsintjan
Bruges, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
jan Mulier
Role: CONTACT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020RCTStaplingcondition
Identifier Type: -
Identifier Source: org_study_id