Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-01-04 @ 4:35 PM
Study NCT ID:
NCT06717061
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-04
First Post:
2024-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Composed Abdominal Wall Analysis. Collecting Tissue and Blood From Patients Undergoing Elective Laparosopic Cholecystectomy. Objective to Describe the Normal Abdominal Wall
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma skin fascia muscle'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-11-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-29', 'studyFirstSubmitDate': '2024-08-19', 'studyFirstSubmitQcDate': '2024-11-29', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collagen composition differs between patients with abdominal wall hernia compared to patients without abdominal wall hernias', 'timeFrame': 'Five years from enrollment', 'description': 'Are there detectable differences in collagen composition in the normal abdominal wall compared to patients who developed a primary or secondary abdominal wall hernia or abdominal rectus diastasis?'}], 'secondaryOutcomes': [{'measure': 'Collagen turnover differs between patients with abdominal wall hernia compared to patients without abdominal wall hernias', 'timeFrame': 'Five years from enrollment.', 'description': 'Are there detectable differences in hyaluronan levels, collagen metabolites, and other biological markers of collagen turnover in abdominal wall or blood when comparing patients with normal abdominal wall and subjects with diseased abdominal wall?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hernia'], 'conditions': ['Hernia', 'Abdominal Wall']}, 'descriptionModule': {'briefSummary': 'People who will be eligible to be asked about participation in the research project are individuals who seek planned care for surgery on their gallbladder due to gallstone disease. The group of patients is chosen as they can represent a normal material that enables comparison with hernia-specific disease in the abdominal wall.\n\nBasic data such as height, weight, sex, age, medication and ASA class will be collected in the form of a study form and stored in a database in a pseudonymised form. During the sampling of biological material, the test subjects will be under general anesthesia, which is why the sampling will not mean increased pain or discomfort other than what is standard after a gallbladder operation with the minimally invasive technique. No additional wound area will be added to the test subjects as the sample pieces are taken from the area at the umbilicus where one operates by default. The sampling is not planned to be repeated, but is performed at the time when the patients perform their cholecystectomy. During the sampling, centimeter-sized pieces of skin, fatty tissue, connective tissue and muscle are taken. Furthermore, serum and plasma will be collected. Two tubes of blood samples (10 ml total) are taken, centrifuged and pipetted before being frozen for later analysis. Pieces of tissue are placed in formalin before transport to the laboratory. The study form regarding the patient\\'s basic state of health will be filled in by the operator on the day of surgery and will be stored pseudonymized when the research subject is assigned a study number.\n\nPatients who are troubled by gallstone disease and are referred for minimally invasive surgery of the gallbladder at the surgical center Västerbotten in Skellefteå will receive oral and written information and will be asked to participate in the study. Approximately 200 cholecystectomies are performed annually at Skellefteå hospital. We understand that within a reasonable period of time it will be possible to include 40 patients, which is the goal, also taking into account the exclusion criteria that exist. The inclusion of patients is expected to take approximately one year'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People who will be eligible to be asked about participation in the research project are individuals who seek planned care for surgery on their gallbladder due to gallstone disease. The group of patients is chosen as they can represent a normal material that enables comparison with hernia-specific disease in the abdominal wall', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Individuals seeking planned care for surgery on their gallbladder due to gallstone disease\n\nExclusion Criteria:\n\n* Disseminated cancer,\n* Ongoing acute inflammation of the gallbladder,\n* Known connective tissue disease,\n* Cortisone medication,\n* BMI \\>35,\n* Clinically measured rectus diastasis of \\>4 cm and/or concurrent abdominal wall hernia\n* Patients operated for abdominal wall hernia'}, 'identificationModule': {'nctId': 'NCT06717061', 'acronym': 'CAWA', 'briefTitle': 'Composed Abdominal Wall Analysis. Collecting Tissue and Blood From Patients Undergoing Elective Laparosopic Cholecystectomy. Objective to Describe the Normal Abdominal Wall', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Västerbotten'}, 'officialTitle': 'CAWA - Composed Abdominal Wall Analysis', 'orgStudyIdInfo': {'id': 'RVasterbotten'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Harvesting of study samples during planned intervention', 'description': 'Patients who are troubled by gallstone disease and are referred for laparoscopic surgery of the gallbladder at the surgical center Västerbotten in Skellefteå will receive oral and written information and will be asked to participate in the study.\n\nOnce the blood samples have been taken, a research nurse will be on site in Skellefteå to collect the samples for centrifugation, pipetting and freezing. Serum and plasma will be shipped frozen to Umeå for analysis. Pieces of tissue are placed in formalin in the operating room and sent to the laboratory.', 'interventionNames': ['Procedure: Harvesting of biological material']}], 'interventions': [{'name': 'Harvesting of biological material', 'type': 'PROCEDURE', 'description': 'During the sampling of biological material, the test subjects will be under general anesthesia, which is why the sampling will not mean increased pain or discomfort other than what is standard after a gallbladder operation with the peephole technique. . The sampling is not planned to be repeated, but is performed at the time when the patients perform their biliary surgery. During the sampling, centimeter-sized pieces of skin, fatty tissue, connective tissue and muscle are taken. Furthermore, serum and plasma will be collected. Two tubes of blood samples (10 ml total) are taken, centrifuged and pipetted before being frozen for later analysis. Pieces of tissue are placed in formalin before transport to the laboratory. The study form regarding the patient\\'s basic state of health will be filled in by the operator on the day of surgery.', 'armGroupLabels': ['Harvesting of study samples during planned intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Skellefteå', 'country': 'Sweden', 'facility': 'Kirurgcentrum Västerbotten', 'geoPoint': {'lat': 64.75067, 'lon': 20.95279}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Västerbotten', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}