Diabetes MellitusNCT03931759
The Effect of Intra-abdominal Pressure
A study testing laparoscopic surgery in people with Diabetes Mellitus and ASA Triad, run by Erzincan University.
Trial summary
The Effect of Intra-abdominal Pressure Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, ASA Triad, Cardiac Autonomic Neuropathy
- What is being tested?
- laparoscopic surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Jun 2020
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes mellitus
- laparoscopic surgery
Who cannot join
- hypertension
- hearth failure
- renal failure
- hepatic failure
- difficult intubation
- shock
About this study
Official title: The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed With Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics
The Effect of Intra-abdominal Pressure
Read the detailed description
The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed with Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics
- Conditions
- Diabetes Mellitus, ASA Triad, Cardiac Autonomic Neuropathy
- Being tested
- laparoscopic surgery
- Keywords
- diabetes mellitus, cardiac autonomic neuropathy, laparoscopic surgery
- Medical subject headings
- Diabetes Mellitus, Asthma, Nasal Polyps, And Aspirin Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgeryDiagnostic test
Also called hearth rate variability
patients with diabetes mellitus in laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Diabetes mellitus | Active comparator | patients with diabetes mellitus Receives: Diagnostic Test: laparoscopic surgery |
| non-Diabetes mellitus | No intervention | patients without diabetes mellitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of heart rate variability in laparoscopic surgeries
The measurement of heart rate variability is used as a method to assess the autonomic nerve system. As the autonomic nerve system dysfunction may complicate the possible peroperative problems in the patients to be operated, the pre-assessment of the autonomic nerve system function should be considered as an acquisition required to be obtained in the daily anesthesia practice.
When we increase the intraabdominal pressure during the laparoscopic surgery, we think that the hemodynamic responses of the diabetic patient group, especially the patients with autonomic neuropathy, to this increasing intraabdominal pressure will be different. The aim of the present study is to investigate the effect of the intraabdominal pressure, applied to the patients diagnosed with diabetes mellitus who will have laparoscopic surgery, on hemodynamics.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study startJun 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective randomize clinical trial
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhan EREN, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931759
- Sponsor's protocol ID
- EBYU1
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2019
- Last updated
- 2 May 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 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed With Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics
- ClinicalTrials.gov ID
- NCT03931759
- Acronym / sponsor ID
- EBYU1
- Conditions
- Diabetes Mellitus, ASA Triad, Cardiac Autonomic Neuropathy
- Keywords
- diabetes mellitus, cardiac autonomic neuropathy, laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 30 Apr 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 Effect of Intra-abdominal Pressure
Detailed description
The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed with Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomize clinical trial
| Arm | Type | Receives |
|---|---|---|
| Diabetes mellitus | Active comparator | Diagnostic Test: laparoscopic surgerypatients with diabetes mellitus |
| non-Diabetes mellitus | No intervention | –patients without diabetes mellitus |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diabetes mellitus
- laparoscopic surgery
Key exclusion criteria (6 listed)
- hypertension
- hearth failure
- renal failure
- hepatic failure
- difficult intubation
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 |
|---|---|---|
| laparoscopic surgeryAlso: hearth rate variabilitypatients with diabetes mellitus in laparoscopic surgery | Diagnostic test | Diabetes mellitus |
Primary outcome
The measurement of heart rate variability in laparoscopic surgeries
Time frame: 1 year
The measurement of heart rate variability is used as a method to assess the autonomic nerve system. As the autonomic nerve system dysfunction may complicate the possible peroperative problems in the patients to be operated, the pre-assessment of the autonomic nerve system function should be considered as an acquisition required to be obtained in the daily anesthesia practice. When we increase the intraabdominal pressure during the laparoscopic surgery, we think that the hemodynamic responses of the diabetic patient group, especially the patients with autonomic neuropathy, to this increasing intraabdominal pressure will be different. The aim of the present study is to investigate the effect of the intraabdominal pressure, applied to the patients diagnosed with diabetes mellitus who will have laparoscopic surgery, on hemodynamics.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic surgery in people with Diabetes Mellitus and ASA Triad, run by Erzincan University.
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 2 inclusion and 6 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 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurement of heart rate variability in laparoscopic surgeries (time frame: 1 year). 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 2 May 2019.