GastrectomyNCT04191564
Effect of Anesthetic Conditions on Stapling Thickness and Quality
A study testing low perfusion state and normal perfusion state in people with Gastrectomy, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
the excluded stomach during sleeve gastrectomy can be investigated post removal outside the patient. During stapling it is common to reduce systolic arterial blood pressure (SAP) below 100 mmHg to reduce peritoneal perfusion and have better compression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrectomy
- What is being tested?
- low perfusion state and normal perfusion state
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2020to Dec 2021
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary sleeve gastrectomy
Who cannot join
- allergy to one of the drugs used intra operative
- liver, renal, cardiac or lung disease with limited function
Trial locations and contacts
1 site in 1 country.
jan Mulier contact
About this study
Official title: Impact of Low Perfusion by High Intraabdominal Pressure and Low Blood Pressure on Stapling Quality Measured as Thickness Difference Between Staples and Stomach Wall and by Bursting Pressure of Excluded Stomach
the excluded stomach during sleeve gastrectomy can be investigated post removal outside the patient. During stapling it is common to reduce systolic arterial blood pressure (SAP) below 100 mmHg to reduce peritoneal perfusion and have better compression. Higher intra abdominal pressures reduce also the peritoneal and mucosal perfusion and might help to improve stapling compression. Stapling compression can be evaluated by measuring stapling thickness and compare it with stomach wall thickness or by measuring leaks during leak test or better outside the patient on the excised stomach with a bursting pressure.
Read the detailed description
Patients are randomized to two groups: group standard perfusion means that the SAP is kept between 100 and 140 mmHg by adapting depth of anesthesia, by level of post expiratory pressure or by giving vasoconstriction.
low perfusion group means that
- 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.
- goal directed fluid therapy using 100 ml/h fluid intravenous and extra load of fluid if pulse pressure variation > 20 %
- 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
- Gastrectomy
- Being tested
- low perfusion state, normal perfusion state
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low perfusion stateProcedure or surgery
reduce SAP below 100 mmHg
normal perfusion stateProcedure or surgery
maintain SAP above 100 mmHg
| Study group | Role | What they receive |
|---|---|---|
| low perfusion | Experimental | 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. Receives: Procedure: low perfusion state |
| normal perfusion | Experimental | Perfusion pressure is maintained above 100 mmHg with free fluid loading iv and the lowest IAP possible during the whole procedure. Receives: Procedure: normal perfusion state |
What is being measured
The primary outcome is the main question the study is designed to answer.
staple thickness in mm
each staple is measured with thickness monitor
Measured: on excised stomach before being discarded within 1 hour after surgery
stomach thickness in mm close to staple measurement
with a constant pressure thickness is measured every 10 seconds till 1 minute
Measured: on excised stomach before being discarded within 1 hour after surgery
bursting pressure in mmHg
excised stomach is inflated with air under water with increasing pressure that is recorded. At moment of first bubbles intra gastric pressure is recorded
Measured: on excised stomach before being discarded within 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study startMar 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- low perfusion
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Mulier, AZ Sint-Jan AV
- Investigators
- Jan Paul Mulier, Principal investigator, AZSint Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191564
- Sponsor's protocol ID
- 2020RCTStaplingcondition
- Status last verified
- Dec 2019
- First submitted
- 1 Dec 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low Perfusion by High Intraabdominal Pressure and Low Blood Pressure on Stapling Quality Measured as Thickness Difference Between Staples and Stomach Wall and by Bursting Pressure of Excluded Stomach
- ClinicalTrials.gov ID
- NCT04191564
- Acronym / sponsor ID
- 2020RCTStaplingcondition
- Conditions
- Gastrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 Dec 2019 (actual)
- 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.
the excluded stomach during sleeve gastrectomy can be investigated post removal outside the patient. During stapling it is common to reduce systolic arterial blood pressure (SAP) below 100 mmHg to reduce peritoneal perfusion and have better compression. Higher intra abdominal pressures reduce also the peritoneal and mucosal perfusion and might help to improve stapling compression. Stapling compression can be evaluated by measuring stapling thickness and compare it with stomach wall thickness or by measuring leaks during leak test or better outside the patient on the excised stomach with a bursting pressure.
Detailed description
Patients are randomized to two groups: group standard perfusion means that the SAP is kept between 100 and 140 mmHg by adapting depth of anesthesia, by level of post expiratory pressure or by giving vasoconstriction.
low perfusion group means that
- 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.
- goal directed fluid therapy using 100 ml/h fluid intravenous and extra load of fluid if pulse pressure variation > 20 %
- 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:
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- low perfusion
| Arm | Type | Receives |
|---|---|---|
| low perfusion | Experimental | Procedure: low perfusion statefluid 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. |
| normal perfusion | Experimental | Procedure: normal perfusion statePerfusion pressure is maintained above 100 mmHg with free fluid loading iv and the lowest IAP possible during the whole procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary sleeve gastrectomy
Key exclusion criteria (2 listed)
- allergy to one of the drugs used intra operative
- liver, renal, cardiac or lung disease with limited function
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 |
|---|---|---|
| low perfusion statereduce SAP below 100 mmHg | Procedure or surgery | low perfusion |
| normal perfusion statemaintain SAP above 100 mmHg | Procedure or surgery | normal perfusion |
Primary outcome
staple thickness in mm
Time frame: on excised stomach before being discarded within 1 hour after surgery
each staple is measured with thickness monitor
stomach thickness in mm close to staple measurement
Time frame: on excised stomach before being discarded within 1 hour after surgery
with a constant pressure thickness is measured every 10 seconds till 1 minute
bursting pressure in mmHg
Time frame: on excised stomach before being discarded within 1 hour after surgery
excised stomach is inflated with air under water with increasing pressure that is recorded. At moment of first bubbles intra gastric pressure is recorded
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- 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.
jan Mulier contact
Jan Paul Mulier principal investigator
AZSint Jan AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low perfusion state and normal perfusion state in people with Gastrectomy, run by AZ Sint-Jan AV at 1 site in Belgium.
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 9 Dec 2019. 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 Belgium. 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 Jan Paul Mulier, PhD (003259452490, jan.mulier@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
staple thickness in mm (time frame: on excised stomach before being discarded within 1 hour after surgery). The study lists 3 primary outcomes in all. 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 9 Dec 2019.