Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06396351
Other study ID # I07-432-22
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date November 30, 2022

Study information

Verified date April 2024
Source Ankara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The authors aimed to evaluate factors influencing abdominal compliance in laparoscopic abdominal surgery.


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


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date November 30, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 82 Years
Eligibility Inclusion Criteria: Aged between 18 and 82 years ASA class I-III Elective abdominal surgery with laparoscopic technique - Exclusion Criteria: Aged below 18 and above 82 ASA IV-V

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Laparoscopic surgery
effect of carbondioxide insufflation on abdominal compliance was evaluated

Locations

Country Name City State
Turkey Ankara University Medical School Anesthesiology and ICU Department Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
Secondary The factors affecting abdominal compliance From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
Secondary 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. From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
Secondary 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. From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
Secondary 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. From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
Secondary 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. From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
Secondary 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. From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
Secondary 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. From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
Secondary 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. From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery
See also
  Status Clinical Trial Phase
Completed NCT01114971 - Labetalol and Esmolol: Vital Signs and Post Operative Pain Management Phase 4
Completed NCT05624346 - The Effect of Respiratory Exercise After Laparoscopic Surgery N/A
Not yet recruiting NCT04999696 - Minimally Invasive Therapy Versus Open Radical Hysterectomy for Management of Early Stage Cervical Cancer N/A
Completed NCT01084200 - Comparison of Sevoflurane, Propofol, and Sevoflurane Plus Propofol for Maintenance of Anaesthesia Phase 4
Not yet recruiting NCT00731107 - XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery. N/A
Not yet recruiting NCT06050161 - Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery N/A
Recruiting NCT05005117 - Laparoscopic Approach for Emergency Colon Resection N/A
Recruiting NCT05436899 - A Pilot Study on Training Simulator Efficacy N/A
Recruiting NCT05542823 - Effect of Cuff Pressure of Endotracheal Tube on POST
Terminated NCT03684304 - The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery N/A
Completed NCT04146090 - Low-pressure vs Standard-pressure in Laparoscopic Cholecystectomy N/A
Terminated NCT01436032 - Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery Phase 3
Active, not recruiting NCT05109130 - Change of Circulating Tumor Cells During Laparoscopic or Transanal Endoscopic Surgery for Rectal Cancer.
Completed NCT04642118 - Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery N/A
Recruiting NCT06150079 - Individualized PEEP Titration on Postoperative Pulmonary Complications N/A
Completed NCT05121454 - Validation of Serenno CUO and IAP Measuring Device
Not yet recruiting NCT05092425 - Analysis of Risk Factors for Children With Heterochronous Indirect Hernia
Recruiting NCT03318185 - Gasless Single-port Laparoscopic-assisted Radical Resection for Rectal Carcinoma N/A
Completed NCT03506555 - Laparoscopic Access in General Surgery: the Closed (Veress Needle) Technique Versus the Open (Hasson) Technique N/A
Recruiting NCT06338865 - Short Title: Standard vs. Lower Pressure Pneumoperitoneum N/A