Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 5:00 PM
Study NCT ID:
NCT00816933
Status:
UNKNOWN
Last Update Posted:
2009-01-06
First Post:
2009-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial on Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001062', 'term': 'Appendectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-05', 'studyFirstSubmitDate': '2009-01-02', 'studyFirstSubmitQcDate': '2009-01-02', 'lastUpdatePostDateStruct': {'date': '2009-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-operative pain', 'timeFrame': 'For 7days'}], 'secondaryOutcomes': [{'measure': 'cosmetic effect', 'timeFrame': 'for 14days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pain', 'operative times', 'complication', 'time to return for normal life', 'pain using VAS score'], 'conditions': ['Appendicitis', 'Pain', 'Complications']}, 'referencesModule': {'references': [{'pmid': '23473061', 'type': 'DERIVED', 'citation': 'Kye BH, Lee J, Kim W, Kim D, Lee D. Comparative study between single-incision and three-port laparoscopic appendectomy: a prospective randomized trial. J Laparoendosc Adv Surg Tech A. 2013 May;23(5):431-6. doi: 10.1089/lap.2012.0284. Epub 2013 Mar 8.'}, {'pmid': '20393336', 'type': 'DERIVED', 'citation': 'Lee J, Baek J, Kim W. Laparoscopic transumbilical single-port appendectomy: initial experience and comparison with three-port appendectomy. Surg Laparosc Endosc Percutan Tech. 2010 Apr;20(2):100-3. doi: 10.1097/SLE.0b013e3181d84922.'}]}, 'descriptionModule': {'briefSummary': 'Appendicitis is the most common benign inflammatory disease that requires an operation.\n\nLaparoscopic appendectomy using three trocar is generally performed, and reveals good surgical outcomes incluing less pain, early recovey, cosmetic effect et al. However, with using three trocar, there are some problems including pain around trocar insertion sites(three portions), wound infecton and scar at trocar insertion sites. For these reasons, more minimal invasive appendectomy is required, with development of laparoscopic instrument,eventually one port sppectomy is developed. So, the investigators assess post-operative Outcomes according to the Number of Trocar.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Appendicitis (clinical or radilogical diagnosis)\n* ASA \\< 4\n\nExclusion Criteria:\n\n* Appendicitis with palpable mass( clinical or radilogical diagnosis)\n* Patient has bleeding tendency\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT00816933', 'briefTitle': 'Trial on Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Prospective Randomized Trial on the Assessment of Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy', 'orgStudyIdInfo': {'id': 'HFHAPPE 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'one port', 'description': 'Patients undergo one port appectomy. Skin incision about 2cm size is made upon umbilicus and dissection is performed to make opening. Then, wound retractcor(Alexis) is iserted on opening site and wound is extended. Rubber glove built-in three 5mm trocars is applied over wound retractor. Pneumoperitoneum is achieved via trocar and appendectomy is performed. After appendectomy, wound is repaired.', 'interventionNames': ['Procedure: appendectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Three ports', 'description': 'Paitents will undergo three port appendectomy. 10 mm trocar is inserted on umbilicus, and two 5mm trocas is inserted low abdomen, left flank respectively.\n\nAppendectomy is performed vis these trocas. After operation, wounds are repaired.', 'interventionNames': ['Procedure: appendectomy']}], 'interventions': [{'name': 'appendectomy', 'type': 'PROCEDURE', 'description': 'appendectomy according to the number of trocar', 'armGroupLabels': ['Three ports', 'one port']}]}, 'contactsLocationsModule': {'locations': [{'zip': '420-717', 'city': 'Bucheon-si', 'state': 'Gyunggi Do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Wook Kim, professor', 'role': 'CONTACT', 'email': 'kimwook@catholic.ac.kr', 'phone': '+82-32-340-7022'}, {'name': 'Junhyun Lee, Instructor', 'role': 'CONTACT', 'email': 'surgeryjun@catholic.ac.kr', 'phone': '+82-32-340-7026'}, {'name': 'Wook Kim, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dongjae Kim, professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Junhyun Lee, Instructor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dept. of Surgery, Holy Family Hospital, College of Medicine, The Catholic University of Korea', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}], 'centralContacts': [{'name': 'Wook Kim, professor', 'role': 'CONTACT', 'email': 'kimwook@catholic.ac.kr', 'phone': '+82-32-340-7022'}, {'name': 'Junhyun Lee, Instructor', 'role': 'CONTACT', 'email': 'surgeryjun@catholi.ac.kr', 'phone': '+82-32-340-7026'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Wook Kim. MD, PhD', 'oldOrganization': 'Professor & Chief'}}}}