Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT05311995
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2022-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Which Trocar Access Site Should We Use in Laparoscopic Appendectomy?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Four trocar tecnıques groups in literature'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity measure', 'timeFrame': '1 year', 'description': 'self reported pain intensity morning. item is scored 0-10 ( 0: no pain- 10: pain as bad as'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopy', 'Minimally invasive surgery', 'appendicitis', 'colorectal'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': "Open appendectomy has been used in the treatment of appendicitis, which is among the most common emergency pathologies worldwide, since the end of the 19th century. In the 20th century, laparoscopic appendectomy came to the fore and the frequency of use increased gradually. Despite the frequency of laparoscopic appendectomy, there is no consensus on the best way to perform each procedural step. One of these steps is the trocar entry areas. In this study, investigator's aim is to compare the trocar entry areas, which are various reports in the literature, and to find the localization with the optimal usage area. 140 patients who underwent laparoscopic appendectomy between 2021-2022 were randomized into four groups and included in the study. Demographic data, peroperative findings, complications, length of stay and post-operative VAS values of the patients were evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent laparoscopic appendectomy\n\nExclusion Criteria:\n\npatients who underwent open surgery and did not want to be involved in the study process'}, 'identificationModule': {'nctId': 'NCT05311995', 'briefTitle': 'Which Trocar Access Site Should We Use in Laparoscopic Appendectomy?', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'Which Trocar Access Site Should We Use in Laparoscopic Appendectomy?', 'orgStudyIdInfo': {'id': '2021/267'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'trocar entry areas:Periumblical, left lower quadrant, suprapubic', 'interventionNames': ['Procedure: Only different trocar sites']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'trocar entry areas: Periumblical, left lower quadrant, right lower quadrant', 'interventionNames': ['Procedure: Only different trocar sites']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 3', 'description': 'trocar entry areas: Periumblical, right lower quadrant, suprapubic', 'interventionNames': ['Procedure: Only different trocar sites']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4', 'description': 'trocar entry areas: Periumblical, left lower quadrant, left upper quadrant', 'interventionNames': ['Procedure: Only different trocar sites']}], 'interventions': [{'name': 'Only different trocar sites', 'type': 'PROCEDURE', 'description': 'Only different trocar sites in literature', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 4', 'group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38090', 'city': 'Kayseri', 'state': 'Kocasinan', 'country': 'Turkey (Türkiye)', 'facility': 'Ersin Gundogan', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof', 'investigatorFullName': 'Ersin Gündoğan', 'investigatorAffiliation': 'Inonu University'}}}}