Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-10 @ 10:25 PM
Study NCT ID:
NCT05178251
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2022-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of SARS-Cov2 Pandemic on Severity of Perioperative Complications in Patients Undergoing Appendectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'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'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2022-01-03', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative complications after appendectomy', 'timeFrame': 'from March 17 to December 14 (2020-2021 versus 2019-2018)', 'description': 'validated classification (Gomes classification)'}, {'measure': 'Postoperative complications after appendectomy', 'timeFrame': 'from March 17 to December 14 (2020-2021 versus 2019-2018)', 'description': 'validated classification (Clavien Dindo classification)'}], 'secondaryOutcomes': [{'measure': 'Delay before surgery', 'timeFrame': 'from March 17 to December 14 (2020-2021 versus 2019-2018)', 'description': 'Time duration from Symptoms onset and appendectomy'}, {'measure': 'Hospitalization duration', 'timeFrame': 'from March 17 to December 14 (2020-2021 versus 2019-2018)', 'description': 'Hospitalization duration'}, {'measure': 'Antibiotherapy duration', 'timeFrame': 'from March 17 to December 14 (2020-2021 versus 2019-2018)', 'description': 'Total antibiotherapy duration'}, {'measure': 'Biological inflammatory syndrom', 'timeFrame': 'from March 17 to December 14 (2020-2021 versus 2019-2018)', 'description': 'Hyperleucocytosis \\> 10000/mm3 and/or PCR \\> 100 mg/L'}, {'measure': 'Type of hospitalisation', 'timeFrame': 'from March 17 to December 14 (2020-2021 versus 2019-2018)', 'description': 'ward / ICU'}, {'measure': 'Delay between appedectomy and postoperative complications', 'timeFrame': 'from March 17 to December 14 (2020-2021 versus 2019-2018)', 'description': '\\< 7 days; 7-30 days; \\> 30 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['appendectomy', 'postoperative complications', 'covid 19'], 'conditions': ['Postoperative Complications', 'Appendicitis', 'COVID-19 Pandemic', 'Appendicitis With Peritonitis']}, 'referencesModule': {'references': [{'pmid': '31797357', 'type': 'BACKGROUND', 'citation': 'Bhangu A; RIFT Study Group on behalf of the West Midlands Research Collaborative. Evaluation of appendicitis risk prediction models in adults with suspected appendicitis. Br J Surg. 2020 Jan;107(1):73-86. doi: 10.1002/bjs.11440. Epub 2019 Dec 3.'}, {'pmid': '23047394', 'type': 'BACKGROUND', 'citation': 'Gomes CA, Nunes TA, Fonseca Chebli JM, Junior CS, Gomes CC. Laparoscopy grading system of acute appendicitis: new insight for future trials. Surg Laparosc Endosc Percutan Tech. 2012 Oct;22(5):463-6. doi: 10.1097/SLE.0b013e318262edf1.'}, {'pmid': '19638912', 'type': 'BACKGROUND', 'citation': 'Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.'}]}, 'descriptionModule': {'briefSummary': "There are 2 types of surgical procedures to remove the appendix : open appendectomy or laparoscopic appendectomy. About 60000 appendectomies are performed every year in France. Early diagnosis of acute appendicitis is essential to prevent the risk of disease progression, leading to complicated appendicitis and an increased risk for mortality. Data regarding appendicitis management in the literature are numerous. However, the impact of COVID-19 pandemic on the management of those patients has led to a decrease in the number of visits for acute appendicitis (ER), but a higher proportion of complicated appendicitis, probably due to the patient's delayed decision to go to emergency department at the onset of clinical symptoms. Complicated appendicitis may also lead to an overuse of antibiotics, a longer hospital stay, and a higher global cost for the health system. This aim of this study was to evaluate whether this hypothesis was valid for the regional NANCY-METZ area (CHR Metz and CHRU Nancy). The main research hypothesis was that the pandemic caused by SARS-COVID 19 was significantly linked to an increased incidence of perioperative complications in patients who underwent an appendectomy for acute appendicitis in this region (North-east part of France).", 'detailedDescription': 'Appendix is a finger-like, blind-ended tube connected to the cecum. The most frequent disease regarding the appendix is appendicitis. Appendicitis is an inflammation of the appendix caused by an obstruction of the lumen of the appendix. This obstruction is most commonly due to an appendicolith (calcified "stone" made of feces). Inflamed lymphoid tissue from a viral infection, parasites, gallstone, or tumors may also cause the blockage. This blockage leads to an increased pressure in the appendix, leading to a decreased blood flow to the tissues of the appendix, and bacterial growth inside the appendix causing inflammation. The combination of inflammation, reduced blood flow to the appendix and distention of the appendix causes tissue injury and lead to infection and potentially necrosis. If this process is left untreated, the appendix may burst, releasing bacteria into the abdominal cavity, leading to a peritonitis with a potential impact on mortality rate. Appendicitis symptoms include right lower abdominal pain, nausea, vomiting, and decreased appetite. Complicated appendicitis is defined as perforated appendicitis, peri-appendicular abscess or peritonitis. Consequently, acute appendicitis is considered to be a surgical emergency.\n\nThere are 2 types of surgical procedures to remove the appendix : open appendectomy or laparoscopic appendectomy. About 60000 appendectomies are performed every year in France. Early diagnosis of acute appendicitis is essential to prevent the risk of disease progression, leading to complicated appendicitis and an increased risk for mortality. Data regarding appendicitis management in the literature are numerous. However, the impact of COVID-19 pandemic on the management of those patients has led to a decrease in the number of visits for acute appendicitis (ER), but a higher proportion of complicated appendicitis, probably due to the patient\'s delayed decision to go to emergency department at the onset of clinical symptoms. Complicated appendicitis may also lead to an overuse of antibiotics, a longer hospital stay, and a higher global cost for the health system. This aim of this study was to evaluate whether this hypothesis was valid for the regional NANCY-METZ area (CHR Metz and CHRU Nancy). The main research hypothesis was that the pandemic caused by SARS-COVID 19 was significantly linked to an increased incidence of perioperative complications in patients who underwent an appendectomy for acute appendicitis in this region (North-east part of France).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients managed at :\n\n* CHR Mercy\n* CHRU nancy\n\nand who underwent appendectomy during the study period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent appendectomy\n\nExclusion Criteria:\n\n* pregnancy\n* protection of vulnerable adults\n* disability'}, 'identificationModule': {'nctId': 'NCT05178251', 'acronym': 'SAP-19', 'briefTitle': 'Impact of SARS-Cov2 Pandemic on Severity of Perioperative Complications in Patients Undergoing Appendectomy', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Impact of SARS-Cov2 Pandemic on Severity of Perioperative Complications in Patients Undergoing Appendectomy', 'orgStudyIdInfo': {'id': '2021PI185'}, 'secondaryIdInfos': [{'id': '2021PI185', 'type': 'OTHER', 'domain': 'DRCI CHRU Nancy'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group without Covid 19 pandemic', 'description': '\\- Patients who underwent an appendectomy from March 17, 2018 to December 14, 2018 and from March 17, 2019 to December 14, 2019', 'interventionNames': ['Procedure: appendectomy']}, {'label': 'Test group with Covid 19 pandemic', 'description': '\\- Patients who underwent an appendectomy from March 17, 2020 to December 14, 2020', 'interventionNames': ['Procedure: appendectomy']}], 'interventions': [{'name': 'appendectomy', 'type': 'PROCEDURE', 'description': 'appendectomy for acute appendicitis', 'armGroupLabels': ['Control group without Covid 19 pandemic', 'Test group with Covid 19 pandemic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Nancy', 'country': 'France', 'facility': 'CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'laurent brunaud', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Laurent BRUNAUD', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}