Ignite Creation Date:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2025-12-26 @ 3:58 PM
Study NCT ID:
NCT06655506
Status:
RECRUITING
Last Update Posted:
2024-10-23
First Post:
2024-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enhanced Recovery Protocols in Gynecologic Oncology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '60 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of hospitalization', 'timeFrame': 'Up to 30 days postoperatively', 'description': 'From date of hospitalization until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months.'}, {'measure': 'Perioperative infections', 'timeFrame': 'Postoperatively (30 days)', 'description': 'Number of participants with postoperative infections (including surgical site, pulmonary and urinary tract infections)'}], 'secondaryOutcomes': [{'measure': 'Postoperative quality of life', 'timeFrame': 'Postoperatively (30 days)', 'description': 'Documentation of quality of life using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C40) and the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaires. The EORTC-QLQ C30 involves 30 questions that are rated from 1 (no impact on quality of life) to 4 (debilitating symptoms). The FACT-G assesses physical, family, emotional and functional wellbeing through 27 questions that are scaled from 0 (no impact) to 4 (very much).'}, {'measure': 'Postoperative morbidity (other than infectious) using the Clavien-Dindo classification', 'timeFrame': '30 days', 'description': 'Major events such as pulmonary embolism,accuse myocardial infarction,etc'}, {'measure': 'Interval to adjuvant therapy', 'timeFrame': 'Up to 100 days', 'description': 'The interval between surgical treatment and adjuvant therapy (radiation and/or chemotherapytreatment) will be documented'}, {'measure': 'Recurrence rates', 'timeFrame': '3 years follow-up', 'description': 'Recurrent disease will be monitored through 3 year of follow up'}, {'measure': 'Overall survival', 'timeFrame': '3 years follow-up', 'description': 'Overall survival of the patients will be measured through 3 year of follow up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ERAS', 'Gynecologic Cancer', 'Perioperative Complication', 'Postoperative Pain', 'Quality of Life', 'Infections']}, 'referencesModule': {'references': [{'pmid': '37652530', 'type': 'BACKGROUND', 'citation': 'Pandraklakis A, Haidopoulos D, Lappas T, Stamatakis E, Valsamidis D, Oikonomou MD, Loutradis D, Rodolakis A, Bisch SP, Nelson G, Thomakos N. Thoracic epidural analgesia as part of an enhanced recovery program in gynecologic oncology: a prospective cohort study. Int J Gynecol Cancer. 2023 Nov 6;33(11):1794-1799. doi: 10.1136/ijgc-2023-004621.'}, {'pmid': '33139130', 'type': 'BACKGROUND', 'citation': 'Bogani G, Sarpietro G, Ferrandina G, Gallotta V, DI Donato V, Ditto A, Pinelli C, Casarin J, Ghezzi F, Scambia G, Raspagliesi F. Enhanced recovery after surgery (ERAS) in gynecology oncology. Eur J Surg Oncol. 2021 May;47(5):952-959. doi: 10.1016/j.ejso.2020.10.030. Epub 2020 Oct 28.'}, {'pmid': '37490193', 'type': 'BACKGROUND', 'citation': 'Nelson G. Enhanced Recovery in Gynecologic Oncology Surgery-State of the Science. Curr Oncol Rep. 2023 Oct;25(10):1097-1104. doi: 10.1007/s11912-023-01442-0. Epub 2023 Jul 25.'}, {'pmid': '37086524', 'type': 'BACKGROUND', 'citation': 'Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21.'}, {'pmid': '32753562', 'type': 'BACKGROUND', 'citation': 'Bhandoria GP, Bhandarkar P, Ahuja V, Maheshwari A, Sekhon RK, Gultekin M, Ayhan A, Demirkiran F, Kahramanoglu I, Wan YL, Knapp P, Dobroch J, Zmaczynski A, Jach R, Nelson G. Enhanced Recovery After Surgery (ERAS) in gynecologic oncology: an international survey of peri-operative practice. Int J Gynecol Cancer. 2020 Oct;30(10):1471-1478. doi: 10.1136/ijgc-2020-001683. Epub 2020 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'Enhanced Recovery After Surgery (ERAS) are developed to provide a systematic structure for managing postsurgical patients.These protocols promote evidenced-based practices and implement a multidisciplinary effort to maintain normal physiology in the perioperative period and aid in earlier recovery. The present study aims to investigate the feasibility of and compliance to a structured ERAS protocol among Gynecological Oncological Centers in Greece as well as to compare the outcomes among patients that fullfilled the minimum number of necessary criteria, compared to those that were enrolled in ERAS protocols but did not meet the sufficient necessary criteria.', 'detailedDescription': 'Enhanced Recovery After Surgery (ERAS) are developed to provide a systematic structure for managing postsurgical patients.These protocols promote evidenced-based practices and implement a multidisciplinary effort to maintain normal physiology in the perioperative period and aid in earlier recovery. ERAS protocols briefly include pre-admission education, pre-operative nutritional care, specific recommendations for pre-operative medications, a standardized anesthetic protocol, perioperative fluid management, multimodal analgesia (MMA), early mobilization, and early removal of urinary catheters.\n\nERGO study study aims to investigate the feasibility of and compliance to a structured ERAS protocol among Gynecological Oncological Centers in Greece as well as to compare the outcomes among patients that fullfilled the minimum number of necessary criteria, compared to those that were enrolled in ERAS protocols but did not meet the sufficient necessary criteria. Patients will be registered into the trial before surgery. Quality assurance program will be in place for both patients that will fulfill the ERAS criteria as well as for those that will not fulfill them.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '25 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In this study, patients that will be operated for gynecological cancer in the collaborating centers described in the Contacts and Locations section will be enrolled.', 'genderDescription': 'Participant eligibility is not based on self-representation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients with gynaecological cancer and an ECOG performance status \\<4, ASA score \\<4.\n\nExclusion Criteria:\n\npatients with metastatic cancer of non-gynaecological origin patients that are not able to follow ERAS protocol due to medical reasons patients with severe debilitating comorbidities (ECOG status 4, ASA score 4-5)'}, 'identificationModule': {'nctId': 'NCT06655506', 'acronym': 'ERGO', 'briefTitle': 'Enhanced Recovery Protocols in Gynecologic Oncology', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'Enhanced Recovery Protocols in Gynecological Cancer Patients: a Feasibility Study', 'orgStudyIdInfo': {'id': '131/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fulfilled ERAS criteria group', 'description': 'This group will include patients that achieved a compliance rate that exceeded 80% of the required predetermined criteria of ERAS protocols.', 'interventionNames': ['Combination Product: ERAS group']}, {'label': 'Control group', 'description': 'This group will include patients that achieved a compliance rate that did not reach at least 80% of the required predetermined criteria of ERAS protocols.', 'interventionNames': ['Combination Product: Control group']}], 'interventions': [{'name': 'ERAS group', 'type': 'COMBINATION_PRODUCT', 'description': 'This group will include patients that achieved a compliance rate that exceeded 80% of the required predetermined criteria of ERAS protocols.', 'armGroupLabels': ['Fulfilled ERAS criteria group']}, {'name': 'Control group', 'type': 'COMBINATION_PRODUCT', 'description': 'This group will include patients that do not follow the predetermined criteria of ERAS protocols', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11523', 'city': 'Athens', 'state': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Vasilios Pergialiotis, MD', 'role': 'CONTACT', 'email': 'pergialiotis@yahoo.com', 'phone': '+306947326459'}], 'facility': 'First department of Obstetrics and Gynecology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11522', 'city': 'Athens', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Dimitrios Papatheodorou, MD, PhD', 'role': 'CONTACT', 'email': 'gynecology1@agsavvas-hosp.gr', 'phone': '2106409408', 'phoneExt': '+30'}], 'facility': 'Agios Savvas Anticancer Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11528', 'city': 'Athens', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Vasilios Pergialiotis, Assistant Professor', 'role': 'CONTACT', 'email': 'pergialiotis@yahoo.com', 'phone': '+306947326459'}, {'name': 'Vasilios Lygizos, MD', 'role': 'CONTACT'}, {'name': 'Maria Fanaki, MD', 'role': 'CONTACT'}, {'name': 'Filippos Ntailianas, MD', 'role': 'CONTACT'}], 'facility': 'First department of Obstetrics and Gynecology, National and Kapodistrian University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '413 34', 'city': 'Larissa', 'state': 'Larissa', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Alexandros Daponte, Professor', 'role': 'CONTACT', 'email': 'dapontea@otenet.gr', 'phone': '2411115654', 'phoneExt': '+30'}], 'facility': 'University of Thessaly', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '18537', 'city': 'Athens', 'state': 'Piraeus', 'status': 'NOT_YET_RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Georgios Vorgias, MD, PhD', 'role': 'CONTACT', 'email': 'gyn@metaxa-hospital.gov.gr'}], 'facility': 'Metaxa Anticancer Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '54642', 'city': 'Thessaloniki', 'state': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Stamatios Petousis, Assistant Professor', 'role': 'CONTACT', 'email': 'petustam@auth.gr', 'phone': '6934050763', 'phoneExt': '+30'}], 'facility': 'Aristotle University of Thessaloniki, Second department of Obstetrics and Gynecology', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54642', 'city': 'Thessaloniki', 'state': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Ioannis Kallogianidis, Professor', 'role': 'CONTACT', 'email': 'ikalogiannidis@gmail.com', 'phone': '231 024 2450', 'phoneExt': '+30'}], 'facility': 'Aristotle University of Thessaloniki, Third department of Obstetrics and Gynecology', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '56429', 'city': 'Thessaloniki', 'state': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Dimitrios Tsolakidis, Associate Professor', 'role': 'CONTACT', 'email': 'dtgyn@auth.gr', 'phone': '2310 999 900', 'phoneExt': '+30'}], 'facility': 'Aristotle University of Thesalloniki, Papageorgiou Hospiral', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'Nikolaos Thomakos, MD, PhD', 'role': 'CONTACT', 'email': 'thomakir@hotmail.com', 'phone': '+302132162291'}, {'name': 'Vasilios Pergialiotis, MD, PhD, MSc', 'role': 'CONTACT', 'email': 'pergialiotis@yahoo.com', 'phone': '+302132162291'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Following study completion and up to 5 years from publication of findings.', 'ipdSharing': 'YES', 'description': 'IPD will be provided upon reasonable request following communication with researchers', 'accessCriteria': 'Data will be provided through a dedicated de-identified redcap database'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Thessaly', 'class': 'OTHER'}, {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, {'name': 'Metaxa Hospital', 'class': 'OTHER'}, {'name': 'Saint Savvas Anticancer Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, MSc, Associate Professor of Obstetrics and Gynecology', 'investigatorFullName': 'Nikolaos Thomakos', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}