Laparoscopic SurgeryNCT06396351
Factors Affecting Abdominal Compliance During CO2 Insufflation in Laparoscopic Abdominal Surgery
An observational study of Laparoscopic Surgery, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The authors aimed to evaluate factors influencing abdominal compliance in laparoscopic abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 30 Nov 2022
- 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 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA I-III patients aged between 18 and 82 years undergoing elective abdominal surgery with laparoscopic technique.
Who may be able to join
- Aged between 18 and 82 years ASA class I-III Elective abdominal surgery with laparoscopic technique
- -
Who cannot join
- Aged below 18 and above 82 ASA IV-V
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Medical School Anesthesiology and ICU Department
Ankara
About this study
Official title: Factors Influencing Abdominal Compliance During CO2 Insufflation in Patients Undergoing Laparoscopic Abdominal Surgery
The authors aimed to evaluate factors influencing abdominal compliance in laparoscopic abdominal surgery.
Read the 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
- Conditions
- Laparoscopic Surgery
- Being tested
- Laparoscopic surgery
- Keywords
- abdominal compliance, intraabdominal pressure, laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgeryProcedure or surgery
Also called Carbondioxide insufflation
effect of carbondioxide insufflation on abdominal compliance was evaluated
What is being measured
The primary outcome is the main question the study is designed to answer.
The factors affecting abdominal compliance
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.
Measured: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
Secondary outcomes (8)
The factors affecting abdominal compliance
Measured: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
The factors affecting abdominal compliance
Effect of age on abdominal compliance. Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.
Measured: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
The factors affecting abdominal compliance
Effect of gender on abdominal compliance. Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.
Measured: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
The factors affecting abdominal compliance
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.
Measured: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
The factors affecting abdominal compliance
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.
Measured: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
The factors affecting abdominal compliance
Effect of previous surgery on abdominal compliance. Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.
Measured: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
The factors affecting abdominal compliance
Effect of pregnancy on abdominal compliance. Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.
Measured: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
The factors affecting abdominal compliance
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.
Measured: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Aug 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanem Cakar Turhan, Ankara University
- Investigators
- Menekse Ozcelik, Study chair, Ankara UniversityEzgi Yıldırım, Principal investigator, Ankara UniversityKeziban Sanem Çakar Turhan, Study chair, Ankara UniversityAysegul Guven, Principal investigator, Ankara UniversityDerya Gökmen, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396351
- Sponsor's protocol ID
- İ07-432-22
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Abdominal Compliance During CO2 Insufflation in Patients Undergoing Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06396351
- Acronym / sponsor ID
- İ07-432-22
- Conditions
- Laparoscopic Surgery
- Keywords
- abdominal compliance, intraabdominal pressure, laparoscopic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 2 May 2024 (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 authors aimed to evaluate factors influencing abdominal compliance in laparoscopic abdominal surgery.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I-III patients aged between 18 and 82 years undergoing elective abdominal surgery with laparoscopic technique.
Key inclusion criteria (2 listed)
- Aged between 18 and 82 years ASA class I-III Elective abdominal surgery with laparoscopic technique
- -
Key exclusion criteria (1 listed)
- Aged below 18 and above 82 ASA IV-V
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: Carbondioxide insufflationeffect of carbondioxide insufflation on abdominal compliance was evaluated | Procedure or surgery | – |
Primary outcome
The factors affecting abdominal compliance
Time frame: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
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.
8 secondary outcomes
The factors affecting abdominal compliance
Time frame: 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
The factors affecting abdominal compliance
Time frame: 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
The factors affecting abdominal compliance
Time frame: 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
The factors affecting abdominal compliance
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
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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.
Menekse Ozcelik study chair
Ankara University
Ezgi Yıldırım principal investigator
Ankara University
Keziban Sanem Çakar Turhan study chair
Ankara University
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 Laparoscopic Surgery, run by Ankara University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 2 May 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 factors affecting abdominal compliance (time frame: From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery). 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 2024; AzTrials last refreshed its copy on 6 Nov 2026.