Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-31 @ 1:42 AM
Study NCT ID:
NCT05430633
Status:
COMPLETED
Last Update Posted:
2022-06-24
First Post:
2022-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Versus Open Appendectomy in Pregnancy
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-18', 'studyFirstSubmitDate': '2022-06-12', 'studyFirstSubmitQcDate': '2022-06-18', 'lastUpdatePostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obstetrical outcomes', 'timeFrame': 'Pregnancy loss within 9 months from appendectomy', 'description': 'Pregnancy loss (fetal demise) - rate of cessation of pregnancy before scheduled delivery'}], 'secondaryOutcomes': [{'measure': 'Surgical outcomes', 'timeFrame': '30 days after appendectomy', 'description': 'Surgical complications - rate of infectious complications within 30 days after appendectomy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Appendicitis', 'Pregnancy Loss', 'Pregnancy Preterm']}, 'referencesModule': {'references': [{'pmid': '31023289', 'type': 'BACKGROUND', 'citation': 'Lee SH, Lee JY, Choi YY, Lee JG. Laparoscopic appendectomy versus open appendectomy for suspected appendicitis during pregnancy: a systematic review and updated meta-analysis. BMC Surg. 2019 Apr 25;19(1):41. doi: 10.1186/s12893-019-0505-9.'}, {'pmid': '29656140', 'type': 'BACKGROUND', 'citation': 'Prodromidou A, Machairas N, Kostakis ID, Molmenti E, Spartalis E, Kakkos A, Lainas GT, Sotiropoulos GC. Outcomes after open and laparoscopic appendectomy during pregnancy: A meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2018 Jun;225:40-50. doi: 10.1016/j.ejogrb.2018.04.010. Epub 2018 Apr 9.'}, {'pmid': '33935257', 'type': 'BACKGROUND', 'citation': 'Zeng Q, Aierken A, Gu SS, Yao G, Apaer S, Anweier N, Wu J, Zhao JM, Li T, Tuxun T. Laparoscopic Versus Open Appendectomy for Appendicitis in Pregnancy: Systematic Review and Meta-Analysis. Surg Laparosc Endosc Percutan Tech. 2021 May 3;31(5):637-644. doi: 10.1097/SLE.0000000000000943.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this retrospective trial is to compare surgical and pregnancy outcomes of pregnant patients who underwent laparoscopic or open appendectomy for acute appendicitis.', 'detailedDescription': "The aim of this retrospective trial is to compare surgical and pregnancy outcomes of pregnant patients who underwent laparoscopic or open appendectomy for acute appendicitis.\n\nPatients' medical records from 2010-2020 were extracted using billing information of the national health insurance fund of Estonia and ICD-10 codes (pregnancy, appendicitis).\n\nCollected data was stored on RedCap electronic database and analyzed with R Studio.\n\nTwo group of patients were compared: pregnant patients who had laparoscopic appendectomy and pregnant patients who had open appendectomy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population consists of pregnant women who were pregnant during appendectomy confirmed either before or after the surgical procedure. The population was derived from the billing information from years 2010-2020 of the national health insurance fund of Estonia.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen with confirmed pregnancy who underwent appendectomy for acute appendicitis.\n\nExclusion Criteria:\n\nWomen who were not pregnant when having an appendectomy'}, 'identificationModule': {'nctId': 'NCT05430633', 'briefTitle': 'Laparoscopic Versus Open Appendectomy in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'North Estonia Medical Centre'}, 'officialTitle': 'Laparoscopic Versus Open Appendectomy in Pregnancy. 10 Year Results of Estonian Population.', 'orgStudyIdInfo': {'id': '345T-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant patients who underwent laparoscopic appendectomy', 'description': 'Pregnant patients who underwent laparoscopic appendectomy', 'interventionNames': ['Procedure: Appendectomy']}, {'label': 'Pregnant patients who underwent open appendectomy', 'description': 'Pregnant patients who underwent open appendectomy', 'interventionNames': ['Procedure: Appendectomy']}], 'interventions': [{'name': 'Appendectomy', 'type': 'PROCEDURE', 'description': 'Appendectomy - laparoscopic or open', 'armGroupLabels': ['Pregnant patients who underwent laparoscopic appendectomy', 'Pregnant patients who underwent open appendectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tallinn', 'country': 'Estonia', 'facility': 'North Estonia Medical Centre', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Estonia Medical Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, general surgeon, MD', 'investigatorFullName': 'Edgar Lipping', 'investigatorAffiliation': 'North Estonia Medical Centre'}}}}