Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-01-01 @ 4:33 AM
Study NCT ID:
NCT01276561
Status:
WITHDRAWN
Last Update Posted:
2017-02-03
First Post:
2011-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Incision Versus Standard Laparoscopic Splenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013103', 'term': 'Spherocytosis, Hereditary'}, {'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-01', 'studyFirstSubmitDate': '2011-01-11', 'studyFirstSubmitQcDate': '2011-01-12', 'lastUpdatePostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative time', 'timeFrame': '1 day', 'description': 'operative time'}], 'secondaryOutcomes': [{'measure': 'operative complications', 'timeFrame': '1 day'}, {'measure': 'wound complications', 'timeFrame': '1 month'}, {'measure': 'cosmesis', 'timeFrame': '6 months'}, {'measure': 'length of stay', 'timeFrame': '1 week'}, {'measure': 'operative difficulty', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laparoscopy', 'splenectomy', 'single site', 'trial'], 'conditions': ['Hereditary Spherocytosis', 'Idiopathic Thrombocytopenic Purpura']}, 'descriptionModule': {'briefSummary': 'This is a prospective trial of single incision versus standard 4-port laparoscopic splenectomy.\n\nThe hypothesis is that there may be a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars. However, the technical difficulty is considerable and the primary outcome is operative time which will be expressed in minutes.', 'detailedDescription': 'This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for splenectomy. We will offer enrollment to several institutions provided they reach institutional approval.\n\nThis will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 30 patients will give us a power of 0.8 with an α of 0.05. Thus operative time is the primary outcome variable by definition. This is recorded and reported in MINUTES.\n\nAfter the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.\n\nSecondary outcome measures include days in the hospital (measured in days), doses of analgesics (measured in doses) and perception of cosmesis as recorded by a scar assessment form which will be filled out by the patient and/or parents at 6 weeks and 6 months. This is a validated quality of life survey with 39 questions and each has 4 categories from best to worst.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Need for splenectomy\n\nExclusion Criteria:\n\n* Splenomegaly'}, 'identificationModule': {'nctId': 'NCT01276561', 'briefTitle': 'Single Incision Versus Standard Laparoscopic Splenectomy', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Single Incision Versus Standard Laparoscopic Splenectomy', 'orgStudyIdInfo': {'id': '09 09 196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single Incision Splenectomy', 'description': 'Patients will undergo splenectomy through a single incision in the umbilicus regardless of the technique or equipment used', 'interventionNames': ['Procedure: Single Incision Splenectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic Splenectomy', 'description': 'Patient will undergo standard laparoscopic splenectomy, port placement is surgeon dependent', 'interventionNames': ['Procedure: Laparoscopic Splenectomy']}], 'interventions': [{'name': 'Single Incision Splenectomy', 'type': 'PROCEDURE', 'otherNames': ['SILS'], 'description': 'Patients will undergo laparoscopic splenectomy through a single incision', 'armGroupLabels': ['Single Incision Splenectomy']}, {'name': 'Laparoscopic Splenectomy', 'type': 'PROCEDURE', 'otherNames': ['Standard'], 'description': 'Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent', 'armGroupLabels': ['Laparoscopic Splenectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Shawn D St. Peter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Shawn St. Peter', 'investigatorAffiliation': "Children's Mercy Hospital Kansas City"}}}}