Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-15 @ 11:13 PM
Study NCT ID:
NCT03004560
Status:
TERMINATED
Last Update Posted:
2020-09-10
First Post:
2016-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychology of Minimally Invasive Surgical Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2016-12-20', 'studyFirstSubmitQcDate': '2016-12-23', 'lastUpdatePostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Psychometric testing questionnaire', 'timeFrame': 'Baseline, 3 weeks, 3 months, 6 months and 1 year post-op', 'description': 'Psychometric testing will be performed to obtain a body image score and to see how/if that changes over time.'}], 'primaryOutcomes': [{'measure': 'Change in Scar satisfaction', 'timeFrame': 'Baseline, 3 weeks, 3 months, 6 months and 1 year post-op', 'description': 'Patients will complete a scar assessment at post-op and routine follow up visits at 3 weeks, 3 months, 6 months, and 1 year.'}], 'secondaryOutcomes': [{'measure': 'Change in the Abdominal pain scale', 'timeFrame': 'Baseline, 1 day post-op, 3 weeks, 3 months, 6 months and 1 year post-op', 'description': 'Patients will complete an abdominal pain scale (0-10) at post-op and routine follow up visits at 3 weeks, 3 months, 6 months, and 1 year.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bariatric', 'standard laparoscopic surgery', 'minimally invasive', 'scars', 'psychology'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to examine the psychological and psychosocial impact of surgical scars after minimally invasive surgery (MIS). 100 adult patients who are about to undergo bariatric procedures through the Duke Metabolic \\& Weight Loss Surgery program will be enrolled in this study. 50 patients will be randomly assigned to standard laparoscopic surgery and 50 will be assigned to the percutaneous group. All patients will complete pre-operative psychometric testing to establish a baseline body-image score as well as a patient's initial subjective perceptions around surgery and surgical scars. Follow-up visits will be done at standard of care timepoints - 3 weeks, 3 and 6 months, and 1 year after surgery. Subjects will complete the same psychometric measures to identify differences in psychological and psychosocial responses to standard laparoscopic and percutaneous scars. Patients will also complete a measure on scar satisfaction. The investigators hope to identify any differences between standard laparoscopic versus percutaneous approaches."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index 35 to 45\n* Undergoing Bariatric Surgery\n\nExclusion Criteria:\n\n* Body Mass Index \\<35 or \\>45\n* Previous Bariatric Surgery'}, 'identificationModule': {'nctId': 'NCT03004560', 'briefTitle': 'Psychology of Minimally Invasive Surgical Scars', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Psychology of Minimally Invasive Surgical Scars', 'orgStudyIdInfo': {'id': 'Pro00075024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Laparoscopic Approach', 'description': 'Minimally invasive laparoscopic procedure with 5-10 mm incisions.', 'interventionNames': ['Procedure: Standard Laparoscopic Approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Percutaneous Approach', 'description': 'Minimally invasive laparoscopic procedure with 2-3 mm incisions.', 'interventionNames': ['Procedure: Percutaneous Approach']}], 'interventions': [{'name': 'Standard Laparoscopic Approach', 'type': 'PROCEDURE', 'description': 'Minimally invasive laparoscopic surgery with 5-10 mm incisions.', 'armGroupLabels': ['Standard Laparoscopic Approach']}, {'name': 'Percutaneous Approach', 'type': 'PROCEDURE', 'description': 'Minimally invasive laparoscopic surgery with 2-3 mm incisions.', 'armGroupLabels': ['Percutaneous Approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Center for Metabolic and Weight Loss Surgery', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Dana Portenier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teleflex', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}