Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-05 @ 1:04 AM
Study NCT ID:
NCT02673528
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Assisted or Total Laparoscopic Appendectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'appendectomy material'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 451}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-01', 'studyFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2016-02-01', 'lastUpdatePostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A weekly change in EQ-5D-3L scores (Euro Qol 5 dimensions 3 levels)', 'timeFrame': 'two times: 7th and 14th day after the surgery', 'description': 'health related evaluation'}, {'measure': 'A weekly change in EQ-VAS scores (Euro Qol Visual Analogue Scale)', 'timeFrame': 'two times: 7th and 14th day after the surgery', 'description': 'visual analogue scale of health related evaluation'}, {'measure': 'Calculation of Cost utility', 'timeFrame': 'within 1 month after surgery', 'description': 'depends on the calculation of hospital based costs and QALY'}], 'secondaryOutcomes': [{'measure': 'Ratio of conversion to TLA', 'timeFrame': 'within the first month after completion of the patient recruitment', 'description': 'Ratio of conversion of laparoscopic assisted to total laparoscopic appendectomy'}, {'measure': 'Mean BMI of patients in the groups', 'timeFrame': 'within 1 month after completion of the patient recruitment', 'description': 'to asses the effect of higher body mass index on the success of procedures the authors will calculate BMI in each group'}, {'measure': 'The rate of the location of appendix', 'timeFrame': 'within 1 month after completion of the patient recruitment', 'description': 'To asses the the effect of the location of the appendix on the preference of surgical intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['appendectomy', 'laparoscopy', 'laparoscopic assisted appendectomy', 'cost utility'], 'conditions': ['Acute Appendicitis']}, 'descriptionModule': {'briefSummary': "Acute appendicitis (AA), is a common intra-abdominal surgical pathology with the overall incidence of approximately 7% and mortality of 0.2-0.8%. Treatment of choice is the surgical removal of the inflamed appendix by using open or laparoscopic appendectomy.\n\nFollowing laparoscopic appendectomy (LA) proved to be a feasible and at least as safe as the corresponding open procedure, it has rapidly gained worldwide acceptance. The traditional approach to LA uses three ports. Over the past decade, successful attempts to perform the procedure with fewer ports have been reported.\n\nThe authors' primary objectives were to 1) identify a simple, safe and feasible way to perform laparoscopic appendectomy in patients with uncomplicated acute appendicitis. 2) determine the health related quality of life of the patients and calculate the cost per quality adjusted life years (QALYs) gained after the procedures (LAA and TLA). 3) Purpose a surgical algorithm when approaching to acute appendicitis with the consideration of quality of health and cost.", 'detailedDescription': "Acute appendicitis (AA), is a common intra-abdominal surgical pathology with the overall incidence of approximately 7% and mortality of 0.2-0.8%. Treatment of choice is the surgical removal of the inflamed appendix by using open or laparoscopic appendectomy. Until the first laparoscopic removal of an inflamed appendix by Kurt Semm in 1980, the gold standard for surgical treatment of acute appendicitis remained open appendectomy as first described by McBurney in 1891.\n\nAt the beginning, LA remained questionable whether the benefits of the procedure outweigh over its disadvantages. However, since laparoscopic technology advances and surgeons' expertise increases, many surgeons have successfully performed a multitude of laparoscopic procedures for AA, with a continued increasing trend in its use. Eventually, after LA proved to be a feasible and at least as safe as the corresponding open procedure, it has rapidly gained worldwide acceptance.\n\nThere are more techniques for LA in the literature but only a few of them have gained to access and described in modern textbooks. The traditional approach to LA uses three ports. Over the past decade, successful attempts to perform the procedure with fewer ports have been reported which include two-port techniques, single-port techniques, and hybrid approaches. The two-port appendectomy technique consist of one port providing access for a rigid telescope with a working channel, and second port for a grasping forceps that is used to retract the appendix. In the single-port assisted technique, after a stitch is placed between the appendix and the anterior abdominal wall to pull the appendix and create a tension to facilitate dissection, and then appendectomy is performed intracorporeally. The hybrid technique formed from the combination of both open and laparoscopic approaches. Namely the appendix is pulled out through the only or one of the port, and a traditional open appendectomy is then performed extracorporeally.\n\nThe authors' primary objectives were to 1) identify a simple, safe and feasible way to perform laparoscopic appendectomy in patients with uncomplicated acute appendicitis. 2) determine the health related quality of life of the patients using Euro Qol (EQ) - 5 Dimensions (5D) - 3 Levels (3L) (EQ-5D-3L) and Visual Analogue Scale (VAS) and calculate the cost per quality adjusted life years (QALYs) gained after the procedures (LAA and TLA). 3) Purpose a surgical algorithm when approaching to acute appendicitis with the consideration of quality of health and cost. For these purposes, a case-control study was designed in January 2015 to investigate these issues."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The control group (Group 1) comprised 108 matched-cases of uncomplicated appendicitis operated with total laparoscopic appendectomy within the period January 2008 through July 2011.\n\nThe study group (Group 2) is represented by 108 consecutive patients diagnosed with uncomplicated acute appendicitis, operated with lap assisted appendectomy.\n\nGroup 3 consisted of 211 patients with uncomplicated appendicitis, in whom Lap assisted ap were unsuccessful because of several reasons, were underwent to Total Lap App within the same period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all acute appendicitis patients underwent total laparoscopic appendectomy or laparoscopic assisted appendectomy\n\nExclusion Criteria:\n\n* no written informed consent'}, 'identificationModule': {'nctId': 'NCT02673528', 'briefTitle': 'Laparoscopic Assisted or Total Laparoscopic Appendectomy', 'organization': {'class': 'OTHER', 'fullName': 'Medical Park Gaziantep Hospital'}, 'officialTitle': 'Laparoscopic Assisted or Total Laparoscopic Appendectomy in Patients With Uncomplicated Acute Appendicitis: a Matched Case-control, Cost-utility Study', 'orgStudyIdInfo': {'id': 'MK-007-LAA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Directly underwent TLA', 'description': 'Patients with the diagnosis who underwent directly total laparoscopic appendectomy', 'interventionNames': ['Procedure: Laparoscopic appendectomy']}, {'label': 'Lap Assisted App', 'description': 'Patients with the diagnosis of acute appendicitis who underwent a successful laparoscopic assisted appendectomy', 'interventionNames': ['Procedure: Laparoscopic appendectomy']}, {'label': 'Advanced to TLA', 'description': 'Patients with the diagnosis of acute appendicitis in whom laparoscopic assisted appendectomy attempted; however, because it fail advanced to total laparoscopic appendectomy.', 'interventionNames': ['Procedure: Laparoscopic appendectomy']}], 'interventions': [{'name': 'Laparoscopic appendectomy', 'type': 'PROCEDURE', 'otherNames': ['laparoscopic assisted appendectomy'], 'description': 'Two types of laparoscopic surgery were performed. Total laparoscopic appendectomy or laparoscopic assisted appendectomy', 'armGroupLabels': ['Advanced to TLA', 'Directly underwent TLA', 'Lap Assisted App']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mehmet Kaplan, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bahçeşehir Üniversitesi Tıp Fakültesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Park Gaziantep Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bahçeşehir University', 'class': 'OTHER'}, {'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of General Surgery', 'investigatorFullName': 'Mehmet Kaplan', 'investigatorAffiliation': 'Medical Park Gaziantep Hospital'}}}}