Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT06000020
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-21
First Post:
2023-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-14', 'studyFirstSubmitDate': '2023-08-14', 'studyFirstSubmitQcDate': '2023-08-14', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of surgery on suspicion of acute appendicitis', 'timeFrame': '3 years', 'description': 'Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis'}, {'measure': 'Risk of surgery on suspicion of acute appendicitis', 'timeFrame': '5 years', 'description': 'Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis'}], 'secondaryOutcomes': [{'measure': 'Reintervention', 'timeFrame': '30 days', 'description': 'Laparoscopy or laparotomy due to complications'}, {'measure': 'Postoperative complications', 'timeFrame': '30 days', 'description': "Postoperative complications according to the 'Clavien-Dindo classification'"}, {'measure': 'Length of stay', 'timeFrame': '30 days', 'description': 'Time from index surgery to discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic appendectomy', 'Normal findings'], 'conditions': ['Appendicitis Acute']}, 'referencesModule': {'references': [{'pmid': '23031764', 'type': 'BACKGROUND', 'citation': 'Jaunoo SS, Hale AL, Masters JP, Jaunoo SR. An international survey of opinion regarding investigation of possible appendicitis and laparoscopic management of a macroscopically normal appendix. Ann R Coll Surg Engl. 2012 Oct;94(7):476-80. doi: 10.1308/003588412X13373405385377.'}, {'pmid': '27437029', 'type': 'BACKGROUND', 'citation': 'Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.'}, {'pmid': '21262032', 'type': 'BACKGROUND', 'citation': 'Bakker OJ, Go PM, Puylaert JB, Kazemier G, Heij HA; Werkgroep richtlijn Diagnostiek en behandeling van acute appendicitis. [Guideline on diagnosis and treatment of acute appendicitis: imaging prior to appendectomy is recommended]. Ned Tijdschr Geneeskd. 2010;154:A303. Dutch.'}, {'pmid': '25245730', 'type': 'BACKGROUND', 'citation': 'Lee M, Paavana T, Mazari F, Wilson TR. The morbidity of negative appendicectomy. Ann R Coll Surg Engl. 2014 Oct;96(7):517-20. doi: 10.1308/003588414X13946184903801.'}, {'pmid': '12686778', 'type': 'BACKGROUND', 'citation': 'Bijnen CL, Van Den Broek WT, Bijnen AB, De Ruiter P, Gouma DJ. Implications of removing a normal appendix. Dig Surg. 2003;20(2):115-21. doi: 10.1159/000069386.'}, {'pmid': '6835144', 'type': 'BACKGROUND', 'citation': 'Gough IR, Morris MI, Pertnikovs EI, Murray MR, Smith MB, Bestmann MS. Consequences of removal of a "normal" appendix. Med J Aust. 1983 Apr 16;1(8):370-2. doi: 10.5694/j.1326-5377.1983.tb99414.x.'}, {'pmid': '30769215', 'type': 'BACKGROUND', 'citation': 'Sorensen AK, Bang-Nielsen A, Levic-Souzani K, Pommergaard HC, Jorgensen AB, Tolstrup MB, Rud B, Kovacevic B, Bulut O. Readmission and reoperation rates following negative diagnostic laparoscopy for clinically suspected appendicitis: The "normal" appendix should not be removed - A retrospective cohort study. Int J Surg. 2019 Apr;64:1-4. doi: 10.1016/j.ijsu.2019.02.001. Epub 2019 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'Based on a regional cohort, this study we will try to demonstrate the superiority of routine laparoscopic appendectomy vs. leaving an intraoperative assessed normal appendix in situ in cases of normal findings at diagnostic laparoscopy. If routine laparoscopic appendectomy is not superior, we will recommend leaving the "normal" appendix in situ.', 'detailedDescription': 'The study is a retrospective cohort study with a superiority design. It will be carried out at the surgical departments of the four public university hospitals providing emergency surgical service to the entire population of 1,8 million in the Capital Region of Denmark.\n\nOn March 17, 2017, a new electronic health record (EHR) had been implemented at three of the hospital, while it was implemented at Copenhagen University Hospital - Bispebjerg on May 20, 2017. These dates mark the start of the inclusion period for each hospital, while the inclusion period ended April 1, 2021 for all four hospitals.\n\nThe "snap boards" covering the relevant operation rooms at the four hospitals will be systematically review. For all cases, where diagnostic laparoscopy was performed on suspicion of acute appendicitis, the EHR will be reviewed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing diagnostic laparoscopy on suspicion of acute appendicitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic laparoscopy with normal intraoperative findings (including mesenteric adenitis\n* Laparoscopic appendectomy and a histopathological normal appendix and otherwise normal intraoperative findings (including mesenteric adenitis)\n\nExclusion Criteria:\n\n* Diagnostic laparoscopy with abnormal intraoperative findings.\n* Laparoscopic appendectomy and a histopathological non-normal appendix.\n* Laparoscopic appendectomy and a histopathological normal appendix and abnormal intraoperative findings.'}, 'identificationModule': {'nctId': 'NCT06000020', 'briefTitle': 'Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Nordsjaellands Hospital'}, 'officialTitle': 'Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study', 'orgStudyIdInfo': {'id': 'LapApp'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnostic laparoscopy', 'description': 'Diagnostic laparoscopy on suspicion of acute appendicitis with normal intraoperative findings (including mesenteric adenitis).'}, {'label': 'Laparoscopic appendectomy', 'description': 'Laparoscopic appendectomy despite normal intraoperative findings (including mesenteric adenitis) and histopathology showing a normal appendix.', 'interventionNames': ['Procedure: Laparoscopic appendectomy']}], 'interventions': [{'name': 'Laparoscopic appendectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic appendectomy as performed as standard world wide. Division of the appendix with laparoscopic stapler.', 'armGroupLabels': ['Laparoscopic appendectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen NV', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital - Bispebjerg'}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital - Herlev', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital - North Zealand', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital - Hvidovre', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Claus A Bertelsen, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'cabertelsen@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordsjaellands Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}