Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-04-22 @ 3:59 PM
Study NCT ID:
NCT05528003
Status:
COMPLETED
Last Update Posted:
2022-09-06
First Post:
2022-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Homemade Versus Commercialized Single-access Port Devices in Single-incision Laparoscopic Appendectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2022-08-31', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total surgical complications', 'timeFrame': 'Complications happened within 30 days', 'description': 'Complications were defined by Clavien-Dindo classification and comprehensive complication index.'}, {'measure': 'Superficial incisional surgical site infection (SSI)', 'timeFrame': 'Complications happened within 30 days', 'description': 'SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification'}, {'measure': 'Deep/organ SSI', 'timeFrame': 'Complications happened within 30 days', 'description': 'SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification'}, {'measure': 'Postoperative ileus', 'timeFrame': 'Complications happened within 30 days', 'description': 'Postoperative ileus was defined as the presence of symptoms and signs of abdominal distention, nausea, or vomiting combined with abdominal radiography, such as plain radiography or CT, within 30 days after SILA.'}], 'secondaryOutcomes': [{'measure': 'Surgical time', 'timeFrame': 'Time from skin incision to application of gauzes', 'description': 'Total time needed for completing surgery'}, {'measure': 'Time to resume soft diet', 'timeFrame': 'The time to resume a soft diet was measured as the duration between the time leaving the recovery room and the time to resume a soft diet recorded in the nursing note.', 'description': 'Total time needed to resume bowel ability to resuming soft diet'}, {'measure': 'Postoperative length of hospitalization', 'timeFrame': 'Postoperative LOH was defined as the duration between leaving the recovery room and discharge.', 'description': 'Total time to stay in hospital'}, {'measure': 'Total medical costs', 'timeFrame': 'From the time patient being brought to emergency room to the time patient being discharged', 'description': 'Medical costs were defined as the medical fees paid by the National Health Insurance and did not include the self-paid equipment fees needed in SILA (e.g., commercialized single-access port devices, or wound protector).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Single-incision laparoscopic appendectomy', 'Single-access port device'], 'conditions': ['Minimally Invasive Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'Homemade and commercialized single-assess port devices are two kinds of port devices commonly used for single-incision laparoscopic appendectomy. This study aimed to compare these two port devices in terms of short-term surgical outcomes and medical costs.', 'detailedDescription': 'The advantages of homemade port devices include accessibility of the composites and lower equipment costs to the patients; however, the potential disadvantage is the easy leakage of CO2, ballooning of the surgical glove, and device instability, leading to difficult maneuverability. On the other hand, commercialized port devices have relatively easy maneuverability, flexibility for instrument changes, and port stability for long-duration surgery ; however, their higher equipment cost is a disadvantage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute appendicitis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients were diagnosed as acute appendicitis and undergoing single-incision laparoscopic appendectomy\n\nExclusion Criteria:\n\n* The patient was not diagnosed as acute appendicitis based on surgical finding or pathological findings\n* The patients underwent surgery other than single-incision laparoscopic surgery'}, 'identificationModule': {'nctId': 'NCT05528003', 'briefTitle': 'Homemade Versus Commercialized Single-access Port Devices in Single-incision Laparoscopic Appendectomy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comparison of Homemade Versus Commercialized Single-access Port Devices for Single-incision Laparoscopic Appendectomy: A Retrospective Comparative Study', 'orgStudyIdInfo': {'id': '202104032RINB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Handmade single-access port device', 'description': 'The homemade single-access device was composed of a wound protector, sterile surgical glove, and three trocars inserted into and secured over three digits of the glove'}, {'label': 'Commercialized single-access port devices', 'description': 'Commercialized single-access port devices including GelPOINT® (Applied Medical, Rancho Santa Margarita, CA, USA) and LAGIPORT® (LAGIS, Taichung, Taiwan)', 'interventionNames': ['Procedure: Commercialized single-access port devices']}], 'interventions': [{'name': 'Commercialized single-access port devices', 'type': 'PROCEDURE', 'description': 'Two kinds of commercialized single-access port devices were used.', 'armGroupLabels': ['Commercialized single-access port devices']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yu-Tso LIAO, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NTUH, Hsin-Chu Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}