Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT05280795
Status:
UNKNOWN
Last Update Posted:
2022-03-15
First Post:
2021-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Audit on Anemia Variation After Major Gynacological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-04', 'studyFirstSubmitDate': '2021-11-20', 'studyFirstSubmitQcDate': '2022-03-04', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of anemia after major gynecological surgery', 'timeFrame': 'one month', 'description': 'percentage of patients with anemia after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia']}, 'referencesModule': {'references': [{'pmid': '8874456', 'type': 'BACKGROUND', 'citation': 'Carson JL, Duff A, Poses RM, Berlin JA, Spence RK, Trout R, Noveck H, Strom BL. Effect of anaemia and cardiovascular disease on surgical mortality and morbidity. Lancet. 1996 Oct 19;348(9034):1055-60. doi: 10.1016/S0140-6736(96)04330-9.'}, {'pmid': '18498676', 'type': 'BACKGROUND', 'citation': 'McLean E, Cogswell M, Egli I, Wojdyla D, de Benoist B. Worldwide prevalence of anaemia, WHO Vitamin and Mineral Nutrition Information System, 1993-2005. Public Health Nutr. 2009 Apr;12(4):444-54. doi: 10.1017/S1368980008002401. Epub 2008 May 23.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to increase our understanding of variability in adherence to anaemia management guidelines and to assess the impact of anaemia management in clinical care following major gynaecological surgery', 'detailedDescription': 'Anemia affects nearly a quarter of the world and is common in surgical patients with a third of patients presenting with preoperative anemia and three quarters of patients discharged from hospital with anemia. The World Health Organization defines anemia as an insufficient circulating red cell mass, with haemoglobin (Hb) concentration of \\< 130 g.l-1 for men and \\< 120 g.l-1 for women .\n\nPerioperative anemia is associated with increased postoperative complications and delayed patient recovery leading to increased post-operative morbidity and mortality. Anaemia also leads to an increased use of allogeneic blood transfusions, which is an independent risk for poorer patient outcomes.\n\nPostoperative anemia can be due to blood loss at operation or secondary to the inflammatory process associated with surgery, which causes an increase in hepcidin production resulting in functional iron deficiency and reduced red cell production.\n\nIn recent years, there has been a significant increase in the use of intravenous iron therapy for preoperative anemia in line with major international guidelines'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'any female 18 to 60 years undegoing major gynecological surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: Adult, 18\\_60 years\n* Procedure: A major gynecological surgery is defined as an operation with an incision into the abdominal cavity and anticipated duration of more than one hour. Procedures performed using any surgical approach, including open and laparoscopic surgery are included.\n* Urgency: Patients undergoing planned (elective or expedited) or unplanned (emergency) surgery\n\nExclusion Criteria:\n\n* Procedures: surgery classified as minor operations such as; diagnostic laparoscopy (emergency or elective), D\\&C.\n* Indication: Palliative procedures as determined pre-operatively and explicitly stated in the medical record or consent form.\n* Return to theatre: Each patient should only be included in the study once. Patients returning to theatre due to complications following earlier surgery'}, 'identificationModule': {'nctId': 'NCT05280795', 'briefTitle': 'Audit on Anemia Variation After Major Gynacological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'an Audit on Postoperative Variations in Anemia Treatment After Major Gynecological Surgery', 'orgStudyIdInfo': {'id': 'anemia follow up'}}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Yossra 1st Rateb, Master', 'role': 'CONTACT', 'email': 'yossrarateb96@gmail.com', 'phone': '002 01146510520'}], 'facility': 'Assuit university'}], 'centralContacts': [{'name': 'Yosra Gamal', 'role': 'CONTACT', 'email': 'yossrarateb96@gmail.com', 'phone': '00201146510520'}, {'name': 'Ahmed Abbas', 'role': 'CONTACT', 'email': 'bmr90@hotmail.com', 'phone': '00201003385183'}], 'overallOfficials': [{'name': 'sayed mostafa', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Yossra G. Rateb', 'investigatorAffiliation': 'Assiut University'}}}}