Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT06396351
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2024-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Factors Affecting Abdominal Compliance During CO2 Insufflation in Laparoscopic Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2024-04-29', 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The factors affecting abdominal compliance', 'timeFrame': 'From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The factors affecting abdominal compliance', 'timeFrame': 'From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery'}, {'measure': 'The factors affecting abdominal compliance', 'timeFrame': 'From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery', 'description': 'Effect of age on abdominal compliance. Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.'}, {'measure': 'The factors affecting abdominal compliance', 'timeFrame': 'From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery', 'description': 'Effect of gender on abdominal compliance. Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.'}, {'measure': 'The factors affecting abdominal compliance', 'timeFrame': 'From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery', 'description': '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.'}, {'measure': 'The factors affecting abdominal compliance', 'timeFrame': 'From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery', 'description': '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.'}, {'measure': 'The factors affecting abdominal compliance', 'timeFrame': 'From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery', 'description': 'Effect of previous surgery on abdominal compliance. Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.'}, {'measure': 'The factors affecting abdominal compliance', 'timeFrame': 'From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery', 'description': 'Effect of pregnancy on abdominal compliance. Abdominal compliance is calculated by dividing intrabdominal volume change to intraabdominal pressure change during abdominal carbondioxide insufflation.'}, {'measure': 'The factors affecting abdominal compliance', 'timeFrame': 'From the beginning of carbondioxide insufflation to the intraabdominal pressure of 15 mmHg during surgery', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abdominal compliance', 'intraabdominal pressure', 'laparoscopic surgery'], 'conditions': ['Laparoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'The authors aimed to evaluate factors influencing abdominal compliance in laparoscopic abdominal surgery.', 'detailedDescription': '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.\n\nThe 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ASA I-III patients aged between 18 and 82 years undergoing elective abdominal surgery with laparoscopic technique.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAged between 18 and 82 years ASA class I-III Elective abdominal surgery with laparoscopic technique\n\n\\-\n\nExclusion Criteria:\n\nAged below 18 and above 82 ASA IV-V'}, 'identificationModule': {'nctId': 'NCT06396351', 'briefTitle': 'Factors Affecting Abdominal Compliance During CO2 Insufflation in Laparoscopic Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Factors Influencing Abdominal Compliance During CO2 Insufflation in Patients Undergoing Laparoscopic Abdominal Surgery', 'orgStudyIdInfo': {'id': 'İ07-432-22'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Laparoscopic surgery', 'type': 'PROCEDURE', 'otherNames': ['Carbondioxide insufflation'], 'description': 'effect of carbondioxide insufflation on abdominal compliance was evaluated'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University Medical School Anesthesiology and ICU Department', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Menekse Ozcelik', 'role': 'STUDY_CHAIR', 'affiliation': 'Ankara University'}, {'name': 'Ezgi Yıldırım', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University'}, {'name': 'Keziban Sanem Çakar Turhan', 'role': 'STUDY_CHAIR', 'affiliation': 'Ankara University'}, {'name': 'Aysegul Guven', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University'}, {'name': 'Derya Gökmen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, MD', 'investigatorFullName': 'Sanem Cakar Turhan', 'investigatorAffiliation': 'Ankara University'}}}}