Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT01464658
Status:
TERMINATED
Last Update Posted:
2018-08-15
First Post:
2010-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study of Functional and Quality of Life Outcomes in Panniculectomy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015434', 'term': 'Panniculitis'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061645', 'term': 'Abdominoplasty'}], 'ancestors': [{'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Due to complexity and cost of study (no outside funding)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2010-08-09', 'studyFirstSubmitQcDate': '2011-11-02', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in lab values, pulmonary function and quality of life', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['panniculitis', 'panniculectomy'], 'conditions': ['Panniculitis']}, 'descriptionModule': {'briefSummary': "Patients with morbid obesity often develop a significant overhanging abdominal pannus. Problems associated with an overhanging pannus can include difficulty performing routine daily activities as well as exercise due to the cumbersome nature of the excess tissue. In addition, the abdominal pannus tissue often becomes infected due to difficulty with hygiene and abnormal circulation and lymphatic flow. There may also be a significant contribution from the pannus to the patient's underlying cardiopulmonary status which is often compromised in morbid obesity patients.\n\nIn addition to weight loss, one of the treatment strategies includes a panniculectomy. A panniculectomy involves resection of the excess abdominal skin and fat in a wedge shape from the lower abdomen. Purported benefits include increased ability to exercise, better quality of life and improved cardiopulmonary function. However, there is a significant morbidity associated with panniculectomy surgery, with wound related complications occurring in as much as 50% of patients with this procedure.\n\nThe investigators hypothesize that the panniculectomy procedure provides long term benefits to this patient population despite significant short term morbidity.", 'detailedDescription': 'This is a prospective trial to determine what if any functional and quality of life benefits are achieved with a panniculectomy. Patients will be evaluated preoperatively and postoperatively with specific interventions aimed at describing their functional status. These interventions will include: echocardiogram, pulmonary function testing, arterial blood gas, functional capacity evaluation by physical therapy, and a quality of life survey. The investigative interventions will be performed postoperatively at 6 months and again at 1 year post surgery. Data will also be gathered on complications such as wound infection, dehiscence, and cardiopulmonary problems.\n\nThere should be no additional risk to the patient as the surgery and procedures listed are already performed routinely on this patient population.\n\nStudy participants will have morbid obesity with significant overhanging pannus that requires surgical intervention.\n\nThis study will compare the preoperative values to post operative values taken at 6 months and then at 1 year post operative. These values include echocardiograms, pulmonary function tests, arterial blood gases and a functional capacity evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be between the ages of 18 - 80 years of age\n* BMI \\> 35\n* non-smoker\n\nExclusion Criteria:\n\n* Subjects under the age of 18 or older than 80 years of age\n* BMI \\< 35 are not eligible for study inclusion\n* smokers are not eligible for inclusion in this study'}, 'identificationModule': {'nctId': 'NCT01464658', 'briefTitle': 'Prospective Study of Functional and Quality of Life Outcomes in Panniculectomy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Prospective Study of Functional and Quality of Life Outcomes in Panniculectomy Patients', 'orgStudyIdInfo': {'id': 'IRB00008184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'panniculectomy', 'description': 'surgical intervention', 'interventionNames': ['Procedure: panniculectomy']}], 'interventions': [{'name': 'panniculectomy', 'type': 'PROCEDURE', 'description': 'surgery', 'armGroupLabels': ['panniculectomy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'James T Thompson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}