Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT05315869
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2022-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
a Retrospective Observational Study Comparing Outcomes of Retrocaecal Appendicitis With Non-retrocaecal Appendicitis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001062', 'term': 'Appendectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 754}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-30', 'studyFirstSubmitDate': '2022-03-20', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patient with postoperative complications', 'timeFrame': '30 days after intervention (appendectomy)', 'description': 'surgical site infections, postoperative ileus, bleeding, internal complications,'}, {'measure': 'Number of patient who undergo converted appendectomy', 'timeFrame': 'during the surgery', 'description': 'Conversion from laparoscopic to open appendectomy'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 days after intervention (appendectomy)', 'description': 'Length of hospital stay after the procedure in days'}, {'measure': 'Duration of procedure', 'timeFrame': 'Throughout the study period (1/2015-4/2020)', 'description': 'Duration of appendectomy in minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Appendicitis', 'Appendicitis Acute', 'Retrocecal Appendicitis']}, 'descriptionModule': {'briefSummary': 'A retrospective observational study investigating whether retrocecal appendicitis associated with worse operative and postoperative outcomes than non-retrocecal appendicitis.', 'detailedDescription': 'Acute appendicitis is the most common cause of acute abdomen requiring acute surgery. The prevalence of the retrocaecal position of the appendix varies significantly between studies from 14 to 36%. Appendectomy of a retrocecal appendix is generally considered to be more demanding procedure than appendectomy of appendices in other positions. The aim of this study is to investigate whether retrocaecal appendicitis is associated with a higher rate of perioperative complications and delayed diagnosis when compared with the other positions.\n\nA retrospective analysis of prospectively collected data of patients undergoing surgery for signs of acute appendicitis from January 2015 to April 2020 at the University Hospital Kralovske Vinohrady. Two groups of patients were be formed: the retrocaecal group and the non-retrocaecal group.\n\nThe following data were recorded: sex, age, body mass index, length of hospital stay, abdominal drain placement, length of surgery, surgical approach (laparoscopic, open or converted), operative finding (normal appendix or catarrhal, phlegmonous, gangrenous, or perforated appendicitis), position of the appendix (retrocaecal or non-retrocaecal positions), histopathological findings (acute inflammation, chronic inflammation, appendiceal tumour or normal appendix), 30-day postoperative complications, 30-day postoperative mortality, symptoms (abdominal pain, nausea, vomiting, diarrhoea, body temperature above 37 degrees celsius, urological complaints and gynaecological complaints), duration of symptoms (from onset to surgery), serious comorbidities and diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients of the treated at the department of surgery of the University Hospital Kralovske Vinohrady', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing surgery for signs of acute appendicitis at the department of surgery of the University Hospital Kralovske Vinohrady between January 2015 to April 2020\n\nExclusion Criteria:\n\n* Patients under 18 years of age'}, 'identificationModule': {'nctId': 'NCT05315869', 'briefTitle': 'a Retrospective Observational Study Comparing Outcomes of Retrocaecal Appendicitis With Non-retrocaecal Appendicitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty Hospital Kralovske Vinohrady'}, 'officialTitle': 'Retrocaecal Appendicitis: Risk Factor for Perioperative Complications?', 'orgStudyIdInfo': {'id': 'AppendicitisFNKV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrocaecal group', 'description': 'Patients who underwent surgery for signs of acute appendicitis and had intraoperative finding of the appendix located in the retrocaecal position.', 'interventionNames': ['Procedure: Appendectomy']}, {'label': 'Non-retrocaecal group', 'description': 'Patients who underwent surgery for signs of acute appendicitis and had intraoperative finding of the appendix not located in the retrocaecal position.', 'interventionNames': ['Procedure: Appendectomy']}], 'interventions': [{'name': 'Appendectomy', 'type': 'PROCEDURE', 'description': 'Surgical procedure for removal of the appendix', 'armGroupLabels': ['Non-retrocaecal group', 'Retrocaecal group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13000', 'city': 'Prague', 'state': 'Prague', 'country': 'Czechia', 'facility': 'Adam Whitley', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Adam Whitley, MUDr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Kralovske Vinohrady'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty Hospital Kralovske Vinohrady', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MUDr.', 'investigatorFullName': 'Adam Whitley', 'investigatorAffiliation': 'Faculty Hospital Kralovske Vinohrady'}}}}