Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-01 @ 9:25 PM
Study NCT ID:
NCT06575166
Status:
TERMINATED
Last Update Posted:
2025-09-19
First Post:
2024-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Abdominal Wall Reconstruction on Abdominal Wall Tension and Intra-Abdominal Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}, {'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Interoperability issue between necessary devices.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2024-08-19', 'studyFirstSubmitQcDate': '2024-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between intra-abdominal pressure (mmHg) and rate of post-operative complications', 'timeFrame': '1 year', 'description': 'Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Post-operative complications measured in proportion of events'}], 'secondaryOutcomes': [{'measure': 'Correlation between intra-abdominal pressure (mmHg) to abdominal wall tension (lbs)', 'timeFrame': '1 year', 'description': 'Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Abdominal wall tension measured using tensiometer in pounds (lbs)'}, {'measure': 'Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to hernia defect size (cm)', 'timeFrame': '1 year', 'description': 'Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Abdominal wall tension measured using tensiometer in pounds (lbs) Hernia defect size (length and width in cm)'}, {'measure': 'Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to airway pressure (cmH2O)', 'timeFrame': '1 year', 'description': 'Intra-abdominal pressure using TraumaGuard catheter in mmHg Abdominal wall tension measured using tensiometer in pounds Airway pressure measured on mechanical ventilator in cmH2O'}, {'measure': 'Temporal changes in renal function (serum Creatinine)', 'timeFrame': '1 year', 'description': 'Creatinine reported on routine laboratory blood work (comprehensive metabolic panel) measured over time'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventral Hernia', 'Incisional Hernia', 'Parastomal Hernia']}, 'descriptionModule': {'briefSummary': 'This is a prospective cohort study. Patients have an incisional or parastomal hernia with \\>20 cm fascial defect on pre-operative imaging who will undergo an anticipated open bilateral transversus abdominis release with retromuscular synthetic mesh will have their abdominal wall tension measured using a tension scale and their intra-abdominal pressure measured using a urinary catheter containing pressure sensors. The investigators aim to quantify the changes, as well as explore and describe the physiologic shifts that may be associated with these changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with an incisional or parastomal hernia with a \\>20 cm fascial defect on pre-operative imaging who undergo an anticipated open bilateral transversus abdominis release with retro-muscular synthetic mesh placement will be included. The investigators anticipate that patients with very large defects will experience the greatest changes in abdominal wall tension and intra-abdominal pressure.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* Incisional or parastomal hernia with \\>20 cm fascial defect on pre-operative imaging\n* Anticipated open bilateral transversus abdominis release with retro-muscular synthetic mesh placement\n\nExclusion Criteria:\n\n* Pregnant patients\n* Require a Legally Authorized Representative (LAR) to sign the informed consent form'}, 'identificationModule': {'nctId': 'NCT06575166', 'briefTitle': 'The Impact of Abdominal Wall Reconstruction on Abdominal Wall Tension and Intra-Abdominal Pressure', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'The Impact of Abdominal Wall Reconstruction on Abdominal Wall Tension and Intra-Abdominal Pressure', 'orgStudyIdInfo': {'id': '24-655'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Abdominal wall tension', 'type': 'DEVICE', 'otherNames': ['Tensiometry'], 'description': 'Abdominal wall tension measurement All patients will have the tension of their abdominal wall measured during surgery using a tension scale or "tensiometer."'}, {'name': 'Intra-abdominal pressure', 'type': 'DEVICE', 'otherNames': ['IAP'], 'description': "Intra-abdominal pressure All patients will have their intra-abdominal pressure continuously monitored using Sentinel's FDA approved TraumaGuard catheter, a pressure-sensing urinary catheter."}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Benjamin T Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Benjamin T. Miller', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}