Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT04753502
Status:
COMPLETED
Last Update Posted:
2021-02-15
First Post:
2021-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic Treatment for Appendicitis During 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': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-30', 'size': 384770, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-01T19:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'negative laparoscopy', 'timeFrame': 'during laparoscopic abdominal exploration', 'description': 'Number of participants whose exploratory laparoscopy did not reveal intra-abdominal pathology and the appendix was macroscopically and microscopically normal'}, {'measure': 'foetal loss', 'timeFrame': 'since the appendectomy until date of pregancy termination by vaginal delivery, cesarean section, or foetal death, assesed up to July 2020', 'description': 'Number of participants that present spontaneous abortion or foetal demise'}, {'measure': 'Preterm labour', 'timeFrame': 'until 37th week of gestation', 'description': 'Number of participants with deliveries or caesarean sections that occurred prior to the 37th week of gestation'}], 'primaryOutcomes': [{'measure': 'Postoperative complication', 'timeFrame': 'within 30 days of surgery', 'description': 'Number of participants that present any deviation from the usual postoperative course within 30 days of surgery'}], 'secondaryOutcomes': [{'measure': 'obstetric complication', 'timeFrame': 'since the appendectomy until date of pregancy termination by vaginal delivery, cesarean section, or foetal death, assesed up to July 2020', 'description': 'Number of participants that present an obstetric complication from the appendectomy until the end of the pregnancy, including foetal death and excluding preterm delivery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute appendicitis', 'pregnancy', 'complications'], 'conditions': ['Other Specified Complications of Pregnancy']}, 'descriptionModule': {'briefSummary': "Acute appendicitis is the most frequent non-obstetric surgical emergency during pregnancy. The benefits of laparoscopy during pregnancy are well known, but complications can occur, and these can affect both the mother and/or the foetus.\n\nObjective: Evaluate results of laparoscopic surgical treatment of acute appendicitis in pregnant women, to analyse the occurrence of adverse postoperative, obstetric and foetal outcomes Methods: Retrospective cohort single-centred observational study on pregnant women with a preoperative diagnosis of acute appendicitis,using computerized medical records' information of pregnant patients admitted to our institution between September 2005 and July 2020", 'detailedDescription': 'Construction and analysis of the database and study protocol were authorized by the Institutional Evaluation Committee under N° B20-010 and P20-070, respectively.\n\nAssuming a 3: 1 relationship between surgery within 48 hours of symptom onset and surgery after 48 hours of 3: 1, we have an 80% power to find a difference in postoperative morbidity between groups of 30% with error type I of .05.\n\nAnalysed variables include: demographic characteristics, gestational age, clinical presentation, symptom duration from onset until surgical resolution, complementary studies, ASA score (Classification of the American Society of Anaesthesiology), intraoperative findings, type of surgery performed, intra and postoperative complications, length of stay, readmissions, use of tocolytics, preterm delivery, birth weight, Apgar score, maternal and foetal mortality, and obstetric and perinatological complications in pregnant patients with a preoperative diagnosis of acute appendicitis.\n\nAny surgery in which the exploratory laparoscopy did not reveal intra-abdominal pathology and the appendix was macroscopically and microscopically normal was classified as a "negative laparoscopy". An "intraoperative complication" was defined as any unexpected intraoperative event, excluding conversion to conventional surgery, which was analysed as an independent event. A "postoperative complication" was defined as any deviation from the usual postoperative course within 30 days of surgery. An "obstetric complication" was one that occurred from the appendectomy until the end of the pregnancy, including foetal death and excluding preterm delivery. Spontaneous abortion and foetal demise were included within the same "foetal loss" outcome. "Preterm labour" was considered to be deliveries or caesarean sections that occurred prior to the 37th week of gestation.\n\nFor continuous variables, mean, standard deviation and / or minimum and maximum, or median and interquartile interval (IQR) were used, according to distribution. For categorical variables the number and corresponding percentages were reported. Continuous parameter comparisons were made using the test for independent samples or Wilcoxon-rank test; and when there were more than two groups, Anova or Kruskal Wallis were applied. For the comparison of categorical variables, Chi-square or Fisher\'s exact test were used, as appropriate. A p \\<0.05 was considered statistically significant. Likewise, a multivariate analysis was performed for the presence of postoperative and obstetric complications, contemplating possible confounders.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant patients of 18 or more years of age admitted to our institution between September 2005 and July 2020 with diagnosis of acute appendicitis.', 'genderDescription': 'participants were pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women 18 years or above\n* preoperative diagnosis of acute appendicitis\n* Diagnosed, operated and followed in Austral University Hospital\n* Signed informed consent for surgery and inclusion in databases for further research\n\nExclusion Criteria:\n\n\\- Patients operated in another hospital and sent to our institution for postoperative controls.'}, 'identificationModule': {'nctId': 'NCT04753502', 'briefTitle': 'Laparoscopic Treatment for Appendicitis During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Austral University, Argentina'}, 'officialTitle': 'Laparoscopic Treatment for Appendicitis During Pregnancy: Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'P20-070'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Laparoscopy', 'type': 'PROCEDURE', 'description': 'laparoscopic removal of pathologic appendix'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1629', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Austral University Hospital', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Carina M Chwat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Austral University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Austral University, Argentina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Carina Chwat', 'investigatorAffiliation': 'Austral University, Argentina'}}}}