SurgeryNCT04172545
Observational Study on Effect of Anesthetic Conditions on Stapling Thickness
An observational study of Surgery, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Measure anesthetic condition used during laparoscopic sleeve gastrectomy stapling. Measure quality of stapling in resected stomach by measuring staple thickness. Find if any relation exists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- stapling
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2020to Dec 2021
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: obese patients undergoing bariatric surgery for the first time and where a sleeve gastrectomy is performed.
Who may be able to join
- primary sleeve gastrectomy
Who cannot join
- stomach disease
- prior surgery on the stomach
Trial locations and contacts
1 site in 1 country.
Mulier contact
About this study
Official title: Impact of Anesthetic Conditions on Stapling Quality Measured as Staple Thickness During Laparoscopic Sleeve Gastrectomy
Measure anesthetic condition used during laparoscopic sleeve gastrectomy stapling. Measure quality of stapling in resected stomach by measuring staple thickness. Find if any relation exists.
Read the detailed description
During each staple firing the staple size, time of compression and anesthetic conditions being systolic arterial pressure, fluids transfused and intra abdominal pressure used are recorded.
After removal of stapled stomach during surgery, thickness of stomach wall and thickness of staple line are measured and compared to evaluate quality of staple formation.
the closer the staple height to the wall thickness the better the quality of stapling. Because no one has ever analyzed this relationship, and certainly not under different anesthetic conditions it is not clear yet if any relationship will be found.
the analysis will help to understand the relation and help to start perhaps a randomised trial to learn what conditions are best to improve staple quality.
- Conditions
- Surgery
- Being tested
- stapling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
staplingProcedure or surgery
staples are fired through the gastric wall after waiting several seconds for compression without attention to blood pressure, fluids given or intra abdominal pressure, but these might have an impact on quality of stapling. therefore the conditions during stapling will be recorded during stapling.
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness of staple line
thickness of staple line measured in micrometers
Measured: intra operative on excised stomach before being discarded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study startAug 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 SurgeryStudies 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
- 10 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
- NCT04172545
- Sponsor's protocol ID
- 2020OSstaplingcondition
- Status last verified
- Mar 2020
- First submitted
- 19 Nov 2019
- Last updated
- 23 Mar 2020
- 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 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anesthetic Conditions on Stapling Quality Measured as Staple Thickness During Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04172545
- Acronym / sponsor ID
- 2020OSstaplingcondition
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 21 Nov 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.
Measure anesthetic condition used during laparoscopic sleeve gastrectomy stapling. Measure quality of stapling in resected stomach by measuring staple thickness. Find if any relation exists.
Detailed description
During each staple firing the staple size, time of compression and anesthetic conditions being systolic arterial pressure, fluids transfused and intra abdominal pressure used are recorded.
After removal of stapled stomach during surgery, thickness of stomach wall and thickness of staple line are measured and compared to evaluate quality of staple formation.
the closer the staple height to the wall thickness the better the quality of stapling. Because no one has ever analyzed this relationship, and certainly not under different anesthetic conditions it is not clear yet if any relationship will be found.
the analysis will help to understand the relation and help to start perhaps a randomised trial to learn what conditions are best to improve staple quality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- obese patients undergoing bariatric surgery for the first time and where a sleeve gastrectomy is performed.
Key inclusion criteria (1 listed)
- primary sleeve gastrectomy
Key exclusion criteria (2 listed)
- stomach disease
- prior surgery on the stomach
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 |
|---|---|---|
| staplingstaples are fired through the gastric wall after waiting several seconds for compression without attention to blood pressure, fluids given or intra abdominal pressure, but these might have an impact on quality of stapling. therefore the conditions during stapling will be recorded during stapling. | Procedure or surgery | – |
Primary outcome
thickness of staple line
Time frame: intra operative on excised stomach before being discarded
thickness of staple line measured in micrometers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- 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.
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?
An observational study of Surgery, 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 23 Mar 2020. 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, MD PhD (+3250452490, jan.mulier@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thickness of staple line (time frame: intra operative on excised stomach before being discarded). 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 23 Mar 2020.