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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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 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]

none

Universal Trial Number (UTN)

U1111-1243-9685

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

obesity

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Surgery

Other surgery

Diet and Nutrition

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]

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]

percentage change in Pleth Variability Index value measured from finger probe of Masimo

Timepoint [1]

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]

percentage change in SpHb value measured from finger probe of Masimo

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

9/12/2019

Date of last participant enrolment

Anticipated

Actual

30/01/2020

Date of last data collection

Anticipated

Actual

30/01/2020

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

sanliurfa

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Gulcin Patmano

Address [1]

Karsiyaka mah. 498. sk. Tema yesilvadi evleri 63000 Haliliye/Sanliurfa

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Harran Univercity Ethics Commitee

Ethics committee address [1]

Sanliurfa - Mardin Karayolu 18. km 63000 Haliliye/Sanliurfa

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

07/10/2019

Approval date [1]

04/11/2019

Ethics approval number [1]

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

Dr Gulcin Patmano

Address

Sanliurfa Mehmet Akif Inan Egitim Arastirma Hastanesi Anestezi Birimi Esentepe mah. Merkez Ertugrul cad. 63300 Haliliye/Sanliurfa

Country

Turkey

Phone

+905554012878

Fax

[email protected]

Contact person for public queries

Name

Gulcin Patmano

Address

Sanliurfa Mehmet Akif Inan Egitim Arastirma Hastanesi Anestezi Birimi Esentepe Mah. Merkez Ertugrul cad. 63300 Haliliye/ Sanliurfa

Country

Turkey

Phone

+905554012878

Fax

[email protected]

Contact person for scientific queries

Name

Gulcin Patmano

Address

Sanliurfa Mehmet Akif Inan Egitim Arastirma Hastanesi Anestezi Birimi Sanliurfa Esentepe mah. Merkez Ertugrul cad. 63300 Haliliye/Sanliurfa

Country

Turkey

Phone

+905554012878

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• anyone who wishes to access it

Conditions for requesting access:
• -

What individual participant data might be shared?

• individual participant data underlying published results only

What types of analyses could be done with individual participant data?

• any purpose

When can requests for individual participant data be made (start and end dates)?

From:
Immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• emailing the principal investigator
Mail adres: [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The effects of body weight and pneumoperitoneum on pleth variability index and total haemoglobin in patients undergoing laparoscopic cholecystectomy: A prospective observational study.	2022	https://dx.doi.org/10.52142/omujecm.39.3.34

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically