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Trial registered on ANZCTR


Registration number
ACTRN12620000169943
Ethics application status
Approved
Date submitted
20/11/2019
Date registered
17/02/2020
Date last updated
17/02/2020
Date data sharing statement initially provided
17/02/2020
Date results information initially provided
17/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of intraabdominal pressure on perfusion values in obese and normal weight patients in laparoscopic cholecystectomy operation
Scientific title
The effects of pneumoperitoneum on Pleth Variability Index and Total Hemoglobin (SpHb) values in obese and normal weight patients in laparoscopic cholecystectomy operation
Secondary ID [1] 299862 0
none
Universal Trial Number (UTN)
U1111-1243-9685
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 315267 0
Condition category
Condition code
Anaesthesiology 313566 313566 0 0
Other anaesthesiology
Surgery 313567 313567 0 0
Other surgery
Diet and Nutrition 313854 313854 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing laparoscopic cholecystectomy will undergo a masimo finger probe (a probe like saturation probe that measures non invasively pleth variability index, perfusion index, hg levels from hand finger) prior to surgery. With this probe, PVI and SpHb values will be measured. 10-12 mmHg pneumoperitoneum will be formed by laparoscopy tower according to the routine procedure of laparoscopic surgeries after the patient is anesthetized (every laparoscopic cholecystectomy operation needs pneumoperitoneum for clear vision by laparoscopic camera). Pneumoperitoneum will be performed with CO2 by general surgeon. Changes in the PVI and SpHb values measured from the Masimo finger probe will be recorded. Duration of interventions will be aproximately 60 minutes. Operations lasting longer than 60 minutes will be excluded from the study.
Intervention code [1] 316127 0
Diagnosis / Prognosis
Comparator / control treatment
this study has 2 groups. One group contains obese patiens (Body Mass Index over 30), The other group contains non-obese patients.
We can say that non-obese patient group is control group
Control group
Active

Outcomes
Primary outcome [1] 322023 0
percentage change in Pleth Variability Index value measured from finger probe of Masimo
Timepoint [1] 322023 0
values measured with finger probe after pneumoperitoneum formation, every 5 minutes later pneumoperiton formation, 1 minute after pneumoperiton desufflation, every 5 minutes later pneumoperiton desufflation
Secondary outcome [1] 377046 0
percentage change in SpHb value measured from finger probe of Masimo
Timepoint [1] 377046 0
values measured with finger probe after pneumoperitoneum formation, every 5 minutes later pneumoperiton formation, 1 minute after pneumoperiton desufflation, every 5 minutes later pneumoperiton desufflation

Eligibility
Key inclusion criteria
ASA (American Society of Anesthesiologists) 1-2 patiens
patients undergoing lararoscopic cholecystectomy
Study Group: body mass index > 30
Control Group : body mass index < 30
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA 3-4 patients
patients who refused to participate in the study
pregnancy
intraoperative bleeding over 100 ml

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
the study contains two groups.
first group contains patients with BMI over 30
second group contains patients with BMI below 30
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
With a power analysis, a total of 48 people would be needed to detect large effects (d=0.5) with %90 power using chi-square

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22131 0
Turkey
State/province [1] 22131 0
sanliurfa

Funding & Sponsors
Funding source category [1] 304323 0
Self funded/Unfunded
Name [1] 304323 0
Gulcin Patmano
Address [1] 304323 0
Karsiyaka mah. 498. sk. Tema yesilvadi evleri 63000 Haliliye/Sanliurfa
Country [1] 304323 0
Turkey
Primary sponsor type
Individual
Name
Gulcin Patmano
Address
Karsiyaka mah. 498. sk. Tema yesilvadi evleri 63000 Haliliye/Sanliurfa
Country
Turkey
Secondary sponsor category [1] 304569 0
None
Name [1] 304569 0
Address [1] 304569 0
Country [1] 304569 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304772 0
Harran Univercity Ethics Commitee
Ethics committee address [1] 304772 0
Sanliurfa - Mardin Karayolu 18. km 63000 Haliliye/Sanliurfa
Ethics committee country [1] 304772 0
Turkey
Date submitted for ethics approval [1] 304772 0
07/10/2019
Approval date [1] 304772 0
04/11/2019
Ethics approval number [1] 304772 0
19/04/20

Summary
Brief summary
With the development of minimal-invasive techniques, laparoscopic procedures are the basis of general surgery. Artificial pneumoperitoneum is usually established by carbon dioxide insufflation and the intraabdominal pressure is frequently maintained between 10 and 15 mmHg.
There are two ways to monitor this volume status: invasive and non-invasive. Non-invasive plethysmographic variability index (PVI) and Total hemoglobin (SpHb) are new parameters used for fluid response in surgical patients. Although these two parameters have been shown to be affected by pneumoperitoneum in laparoscopic surgery, the role of obesity has not been established.
These parameters were evaluated in gastric bypass operations to evaluate the effects of pneumoperitoneum in obese patients and their changes were evaluated. However, there are no studies evaluating obese patients and normal weight patients with the same operation type and the same abdominal pressure values.
Our aim in this study was to determine how PVI and SpHb are affected by pneumoperitoneum in obese and normal weight patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98154 0
Dr Gulcin Patmano
Address 98154 0
Sanliurfa Mehmet Akif Inan Egitim Arastirma Hastanesi Anestezi Birimi
Esentepe mah. Merkez Ertugrul cad. 63300 Haliliye/Sanliurfa
Country 98154 0
Turkey
Phone 98154 0
+905554012878
Fax 98154 0
Email 98154 0
gulcinpatmano@gmail.com
Contact person for public queries
Name 98155 0
Dr Gulcin Patmano
Address 98155 0
Sanliurfa Mehmet Akif Inan Egitim Arastirma Hastanesi Anestezi Birimi
Esentepe Mah. Merkez Ertugrul cad. 63300 Haliliye/ Sanliurfa
Country 98155 0
Turkey
Phone 98155 0
+905554012878
Fax 98155 0
Email 98155 0
gulcinpatmano@gmail.com
Contact person for scientific queries
Name 98156 0
Dr Gulcin Patmano
Address 98156 0
Sanliurfa Mehmet Akif Inan Egitim Arastirma Hastanesi Anestezi Birimi Sanliurfa
Esentepe mah. Merkez Ertugrul cad. 63300 Haliliye/Sanliurfa
Country 98156 0
Turkey
Phone 98156 0
+905554012878
Fax 98156 0
Email 98156 0
gulcinpatmano@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
emailing the principal investigator
Mail adres: gulcinpatmano@gmail.com
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
Pneumoperitonium in obese can lead to errors in PVI and SpHb monitoring. Although these two parameters are very valuable in intraoperative follow-up, they should be used carefully during laparoscopic procedures in obese patients. If these two parameters (obesity and pneumoperitoneum) are considered to be used in bariatric surgeries, which are the most common surgical procedures, this information should be considered.