Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-01-05 @ 5:56 PM
Study NCT ID:
NCT03750032
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2018-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technical Modifications of Appendicular Stump Closure During 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking will be used in the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients will be randomized into three groups of various appendicular stump closure.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2018-11-02', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative time', 'timeFrame': '12 months', 'description': 'Operative time will be measured in minutes and analysed.'}, {'measure': 'Incidence of intraoperative and postoperative complications', 'timeFrame': '12 months', 'description': 'The incidence of intraoperative and postoperative complications will be analysed in all groups of study subjects.'}], 'secondaryOutcomes': [{'measure': 'Costs of surgery', 'timeFrame': '12 months', 'description': 'Costs of surgery will be analysed for all groups of study subjects.'}, {'measure': 'Costs of hospitalization', 'timeFrame': '12 months', 'description': 'The overall costs of hospitalisation will be analysed for all groups of study subjects.'}, {'measure': 'Costs of treatment of complications', 'timeFrame': '12 months', 'description': 'Costs of treatment of complications will be analysed for all groups of study subjects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute appendicitis', 'laparoscopy', 'closure of appendicular stump', 'economical and medical outcomes'], 'conditions': ['Acute Appendicitis']}, 'referencesModule': {'references': [{'pmid': '25097680', 'type': 'BACKGROUND', 'citation': 'Mayir B, Bilecik T, Ensari CO, Oruc MT. Laparoscopic appendectomy with hand-made loop. Wideochir Inne Tech Maloinwazyjne. 2014 Jun;9(2):152-6. doi: 10.5114/wiitm.2014.41624. Epub 2014 Mar 24.'}, {'pmid': '26963058', 'type': 'BACKGROUND', 'citation': 'Matyja M, Strzalka M, Rembiasz K. Laparosocopic Appendectomy, Cost-Effectiveness of Three Different Techniques Used to Close the Appendix Stump. Pol Przegl Chir. 2015 Dec;87(12):634-7. doi: 10.1515/pjs-2016-0015.'}, {'pmid': '26668532', 'type': 'BACKGROUND', 'citation': 'Mayir B, Ensari CO, Bilecik T, Aslaner A, Oruc MT. Methods for closure of appendix stump during laparoscopic appendectomy procedure. Ulus Cerrahi Derg. 2015 Aug 18;31(4):229-31. doi: 10.5152/UCD.2015.2768. eCollection 2015.'}, {'pmid': '27121413', 'type': 'BACKGROUND', 'citation': 'Yildiz I, Koca S. Is There An Ideal Stump Closure Technique In Laparoscopic Appendectomy? Surg Technol Int. 2016 Apr;28:117-20.'}, {'pmid': '27627887', 'type': 'BACKGROUND', 'citation': 'Delibegovic S, Mehmedovic Z. Erratum to: The Influence of the Appendiceal Base Diameter on Appendix Stump Closure in Laparoscopic Appendectomy. World J Surg. 2016 Nov;40(11):2832. doi: 10.1007/s00268-016-3709-5. No abstract available.'}, {'pmid': '34059039', 'type': 'DERIVED', 'citation': 'Ihnat P, Tesar M, Tulinsky L, Ihnat Rudinska L, Okantey O, Durdik S. A randomized clinical trial of technical modifications of appendix stump closure during laparoscopic appendectomy for uncomplicated acute appendicitis. BMC Surg. 2021 May 31;21(1):272. doi: 10.1186/s12893-021-01279-z.'}]}, 'descriptionModule': {'briefSummary': 'Laparoscopic appendectomy (L-APPE) presents a golden standard in the treatment of acute appendicitis nowadays. However, there are ongoing controversies regarding the ideal technique of appendicular stump closure during L-APPE in the published literature. Several technical modifications of appendicular stump closure are available at the present - closure using endoloop, endostapler or Hem-o-lock clips. The aim of the proposed project (CAS study) is to compare medical and economic outcomes of patients undergoing L-APPE with different methods of appendicular stump closure (endostapler, endoloop and Hem-o-lock clips).', 'detailedDescription': 'Acute appendicitis presents one of the most common surgical illnesses which affect approximately 7% of the western population. In the Czech Republic, 11664 patients were hospitalized and operated for the diagnosis of acute appendicitis (K35-K38) during 2016. It might seem that the procedure of appendectomy will be guided by a clear algorithm for its frequency, but it is not so. Because of acute appendicitis, appendectomy may be performed via laparotomy or laparoscopy (minimally invasive surgery). During laparoscopic appendectomy (L-APPE), there are no clear recommendations regarding trocar placement, methods of dividing appendicular mesenteriolum, methods of appendicular stump closure or appendicular stump sinking.\n\nThe proposed clinical study is focused on the issue of the appendicular base interruption during L-APPE. At the present, there are several technical modifications of appendicular stump closure - by means of endoloop (the suture loop from absorbable fiber), endostapler or using Hem-o-lock clips. The performed literature search revealed that evidence-based medicine data regarding the optimal way of appendicular stump closure are insufficient. That is why the investigators have decided to conduct a prospective randomized single-center clinical study aimed to compare different technical modifications of appendicular stump closure during L-APPE. Within a study period, all patients undergoing L-APPE at the University Hospital Ostrava will be randomized to one of the technical modifications of appendicular stump closure.\n\nThe aim of the project (CAS study) is to compare medical and economic outcomes of patients undergoing L-APPE with different methods of appendicular stump closure (endostapler, endoloop and Hem-o-lock clips). The operative time, intraoperative and postoperative complications will be the primary outcome measures of the study, economic outcomes will be the secondary outcome measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years\n* acute appendicitis\n* laparoscopic approach\n* signed informed content\n\nExclusion Criteria:\n\n\\- necrosis or advanced inflammatory changes in the area of appendicular stump'}, 'identificationModule': {'nctId': 'NCT03750032', 'acronym': 'CAS', 'briefTitle': 'Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Ostrava'}, 'officialTitle': 'Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy', 'orgStudyIdInfo': {'id': 'FNO-CHIR-CAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stapler appendectomy', 'description': 'A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using a stapler.', 'interventionNames': ['Procedure: Stapler appendectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Endoloop', 'description': 'A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using endoloop.', 'interventionNames': ['Procedure: Endoloop']}, {'type': 'EXPERIMENTAL', 'label': 'Hem-O-Lock', 'description': 'A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using Hem-O-Lock.', 'interventionNames': ['Procedure: Hem-O-Lock']}], 'interventions': [{'name': 'Stapler appendectomy', 'type': 'PROCEDURE', 'description': 'The patients randomised for this intervention will undergo stapler appendectomy.', 'armGroupLabels': ['Stapler appendectomy']}, {'name': 'Endoloop', 'type': 'PROCEDURE', 'description': 'The patients randomised for this intervention will undergo appendicular stump closure using Endoloop.', 'armGroupLabels': ['Endoloop']}, {'name': 'Hem-O-Lock', 'type': 'PROCEDURE', 'description': 'The patients randomised for this intervention will undergo appendicular stump closure using Hem-O-Lock.', 'armGroupLabels': ['Hem-O-Lock']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70852', 'city': 'Ostrava', 'state': 'Moravian-Silesian Region', 'country': 'Czechia', 'facility': 'University Hospital Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}], 'overallOfficials': [{'name': 'Peter Ihnát, Ass.Prof.,MD,PhD,MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ostrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The investigators have not decided to make the individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Ostrava', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}