Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 6:30 PM
Study NCT ID:
NCT06008834
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2023-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Interventional Pilot Study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2023-08-23', 'studyFirstSubmitQcDate': '2023-08-23', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Readmission', 'timeFrame': '30 days after surgery', 'description': 'Hospital readmission after first-day hospital discharge'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '30 days after surgery', 'description': 'Postoperative complications after first-day hospital discharge acording to Clavien-Dindo classification'}, {'measure': 'Emergency Department re-consultation', 'timeFrame': '30 days after surgery', 'description': 'Emergency Department re-consultation with no readmission after first-day hospital discharge'}, {'measure': 'Domiciliary Follow-up', 'timeFrame': '30 days after surgery', 'description': 'Domiciliary follow-up mean time before domiciliary discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Disorders', 'Surgery']}, 'descriptionModule': {'briefSummary': 'The enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. This type of approach has led to an earlier hospital discharge of patients with a low rate of postoperative complications.\n\nPurpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital discharge and domiciliary follow-up for minimal invasive colectomy.\n\nMethod: unicenter pilot study of patients with indication of minimally invasive right colectomy or sigmidectomy who will follow an ERAS protocol according to international guidelines and will be discharged the first day of surgery with a domiciliary follow-up. Hospital readmission is considered as the primary outcome. A total sample of 40 cases is considered, with 20 right colectomies and 20 sigmoidectomies. An independent analysis of both techniques will be performed.', 'detailedDescription': 'Introduction: the enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. The key elements of ERAS protocols include preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization. This type of approach has led to an earlier hospital discharge of patients with a low rate of postoperative complications.\n\nPurpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital discharge and domiciliary follow-up for minimal invasive colectomy.\n\nMethod: unicenter pilot study of patients with indication of minimally invasive right colectomy or sigmidectomy who will follow an ERAS protocol according to international guidelines and will be discharged the first day of surgery with a domiciliary follow-up.\n\nOutcomes:\n\n* Primary: hospital readmission\n* Secondary: postoperative complications (Clavien-Dindo), domiciliary follow-up mean time before final postoperative discharge, emergency department re-consulting.\n\nSample: a total sample of 40 cases is considered, with 20 right colectomies and 20 sigmoidectomies.\n\nAnalysis: an independent analysis of both techniques will be performed. Pilot study without control branch.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pacients who undergo a minimal invasive sigmoidectomy or right colectomy.\n* Benign or malignant desease.\n* No expected stoma\n* ASA ≤ III\n* Family support\n\nExclusion Criteria:\n\n* Emergency surgery\n* Anticoagulant therapy\n* Recent immunosupresor therapy (less than one month)\n* Anemia (Male Hb \\>120 g/L, Female Hb \\>110 g/L)\n* Malnutrition (Albumine \\>35 g/L)\n* Dementia\n* Moderate or high frailty\n* Syncronic neoplasia\n* Previous colorectal surgery'}, 'identificationModule': {'nctId': 'NCT06008834', 'briefTitle': 'First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery: Pilot Study', 'orgStudyIdInfo': {'id': 'CIR2022020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': 'Patients who undergo a minimal invasive colorectal surgery and are included in the first-day discharge protocol with domiciliary follow-up', 'interventionNames': ['Procedure: First-day discharge protocol']}], 'interventions': [{'name': 'First-day discharge protocol', 'type': 'PROCEDURE', 'description': 'Enhance Recovery after Surgery (ERAS) protocol consisting in perioperative mesures and first-day hospital discharge with domiciliary follow-up', 'armGroupLabels': ['Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Parc Tauli University Hospital', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'centralContacts': [{'name': 'Anna Pallisera-Lloveras, MD, PhD', 'role': 'CONTACT', 'email': 'apallill@gmail.com', 'phone': '34-93-723-1010', 'phoneExt': '21490'}, {'name': 'Laura Mora-Lopez, MD, PhD', 'role': 'CONTACT', 'email': 'mora.lopez.laura@gmail.com', 'phone': '34-93-723-1010', 'phoneExt': '21490'}], 'overallOfficials': [{'name': 'Anna Pallisera-Lloveras, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporacio Parc Tauli. Parc Tauli University Hospital'}, {'name': 'Laura Mora-Lopez, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corporacio Parc Tauli. Parc Tauli University Hospital'}, {'name': 'Oriol Pino-Perez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporacio Parc Tauli. Parc Tauli University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Anna Pallisera-Lloveras', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}