Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT06732635
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2024-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enhanced Recovery After Surgery (ERAS) for Laparoscopic Hysterectomy at Low Risk Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080482', 'term': 'Enhanced Recovery After Surgery'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A controlled, randomized, parallel-group, open-label, interventional, single-center clinical trial in which the intervention group will be managed according to the multimodal rehabilitation protocol (RICA clinical pathway), and the control group will receive traditional care that has been provided up to now.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-12', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complications', 'timeFrame': '30 days after surgery', 'description': 'Clavien-Dindo Classification. Scale rated from grade 1 to grade 5 The Clavien-Dindo (CD) classification is widely used in the reporting of surgical complications in scientific literature. It groups complications based on the level of intervention required to resolve them, and benefits from simplicity and ease of use, both of which contribute its to high inter-rater reliability'}, {'measure': 'Quality of life (QoL)', 'timeFrame': 'Preoperative, 3, 10 and 30 days after surgery', 'description': 'Core Quality of Life questionnaire (EORTC QLG Core Questionnaire) (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients. You should select the option that best represents you from the options 1Not at All, 2A little, 3Quite a bit, 4Very much'}, {'measure': 'Level of Pain', 'timeFrame': 'Preoperative, 3, 10 and 30 days after surgery', 'description': "Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line."}], 'primaryOutcomes': [{'measure': 'Lengh of stay', 'timeFrame': '30 days after surgery', 'description': 'Days of hospitalitation'}, {'measure': 'Day of discharge', 'timeFrame': '30 days after surgery'}, {'measure': 'Readmisión', 'timeFrame': 'During 1st month after surgery', 'description': 'yes/no'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial Cancer']}, 'descriptionModule': {'briefSummary': 'Enhanced recovery after surgery (ERAS) programs are designed to achieve early recovery after surgery and a shorter length of stay (LOS) at hospital.\n\nSo far there are only three prospective, randomised studies that exclusively analyze patients affected by oncogynecological pathology providing a high level of scientific evidence. To our knowledge, no studies have been conducted specifically on ERAS pathways in endometrial cancer treated by laparoscopy. This study aims to evaluate whether ERAS pathways are beneficial for patients with endometrial cancer, particularly among low-risk early endometrial cancer operated by laparoscopy. Length of stay (LOS), perioperative morbidity and mortality, and perioperative quality of life were analyzed comparing both ERAS and Conventional protocols groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing laparoscopic hysterectomy for stage 1A and 1B endometrial cancer\n\nExclusion Criteria:\n\n* Age under 18 years\n* ASA IV\n* Liver cirrhosis\n* Psychiatric illness\n* Urgent surgery\n* The patient's desire not to participate."}, 'identificationModule': {'nctId': 'NCT06732635', 'acronym': 'FAST-TRACK', 'briefTitle': 'Enhanced Recovery After Surgery (ERAS) for Laparoscopic Hysterectomy at Low Risk Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia'}, 'officialTitle': 'Enhanced Recovery After Surgery (ERAS) for Laparoscopic Hysterectomy at Low Risk Endometrial Cancer: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ERAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional'}, {'type': 'EXPERIMENTAL', 'label': 'ERAS', 'description': 'Enhanced recovery after surgery (ERAS) programs are designed to achieve early recovery after surgery and a shorter length of stay (LOS) at hospital.', 'interventionNames': ['Procedure: Enhanced recovery after surgery (ERAS)']}], 'interventions': [{'name': 'Enhanced recovery after surgery (ERAS)', 'type': 'PROCEDURE', 'description': 'Enhanced recovery after surgery (ERAS) programs are designed to achieve early recovery after surgery and a shorter length of stay (LOS) at hospital.', 'armGroupLabels': ['ERAS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30120', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}