- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06396351
Factors Affecting Abdominal Compliance During CO2 Insufflation in Laparoscopic Abdominal Surgery
Factors Influencing Abdominal Compliance During CO2 Insufflation in Patients Undergoing Laparoscopic Abdominal Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During laparoscopic surgery, pneumoperitoneum is achieved by insufflating carbon dioxide (CO2) gas into the abdominal cavity to create a safe working space. Pneumoperitoneum-induced elevation in intra-abdominal pressure (IAP) can result in various complications. Abdominal compliance (AC), represents the slope of the P-V curve of the abdominal cavity and is a measure of the ease of abdominal dilatation, is important to balance between surgical safety and complications. The aim of this study was to determine the effect of demographic and anatomic variables on AC.
The study included 90 patients who underwent laparoscopic abdominal surgery. Subcutaneous adipose tissue and abdominal muscle thickness were measured ultrasonographically. Mean AC was calculated during insufflation using the formula (ΔV/ΔP). The relationship between demographic and anatomic variables and AC was investigated
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey
- Ankara University Medical School Anesthesiology and ICU Department
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Aged between 18 and 82 years ASA class I-III Elective abdominal surgery with laparoscopic technique
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Exclusion Criteria:
Aged below 18 and above 82 ASA IV-V
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The factors affecting abdominal compliance
Time Frame: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
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Effect of rectus muscle thickness and lateral abdominal muscle group thickness on abdominal compliance.
Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.
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From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The factors affecting abdominal compliance
Time Frame: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
|
The factors affecting abdominal compliance
Time Frame: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
Effect of age on abdominal compliance.
Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.
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From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
The factors affecting abdominal compliance
Time Frame: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
Effect of gender on abdominal compliance.
Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.
|
From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
The factors affecting abdominal compliance
Time Frame: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
Effect of ASA physical status on abdominal compliance.
Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.
|
From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
The factors affecting abdominal compliance
Time Frame: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
Effect of body mass index on abdominal compliance.
Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.
|
From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
The factors affecting abdominal compliance
Time Frame: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
Effect of previous surgery on abdominal compliance.
Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.
|
From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
The factors affecting abdominal compliance
Time Frame: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
Effect of pregnancy on abdominal compliance.
Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.
|
From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
The factors affecting abdominal compliance
Time Frame: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
Effect of subcutaneous adipose tissue thickness on abdominal compliance.
Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.
|
From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Menekse Ozcelik, Ankara University
- Principal Investigator: Ezgi Yıldırım, Ankara University
- Study Chair: Keziban Sanem Çakar Turhan, Ankara University
- Principal Investigator: Aysegul Guven, Ankara University
- Principal Investigator: Derya Gökmen, Ankara University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- İ07-432-22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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