Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
Study NCT ID:
NCT04174950
Status:
UNKNOWN
Last Update Posted:
2019-11-22
First Post:
2019-07-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perioperative ERAS Based Nursing Intervention for Laryngeal Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007822', 'term': 'Laryngeal Neoplasms'}], 'ancestors': [{'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were allocated into two groups randomly.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2019-07-12', 'studyFirstSubmitQcDate': '2019-11-20', 'lastUpdatePostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hope level', 'timeFrame': 'the day before surgery', 'description': 'Herth Hope Index which have 12 items. Each item is rated from 1 to 4. Score 1 represents lowest level. Score 4 represents highest level. Total score is 48.'}, {'measure': 'Hope level', 'timeFrame': 'Day 10 after surgery', 'description': 'Herth Hope Index which have 12 items. Each item is rated from 1 to 4. Score 1 represents lowest level. Score 4 represents highest level. Total score is 48.'}], 'secondaryOutcomes': [{'measure': 'Ambulation time', 'timeFrame': 'Day 3 after surgery', 'description': 'record the time of first ambulation'}, {'measure': 'Level of Pain', 'timeFrame': 'Day 3 after surgery', 'description': 'Numerical rating scale is a common pain rating scale. The score ranges from 0 to 10. 0 is no pain, 10 is the most severe pain.'}, {'measure': 'Postoperative complication', 'timeFrame': 'Day 30 after surgery', 'description': 'incidence of infection, malnutrition and Viscosity of sputum'}, {'measure': 'Length of stay', 'timeFrame': 'Day 30 after surgery', 'description': 'the days of hospitalization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laryngeal cancer', 'enhanced recovery after surgery', 'hope level'], 'conditions': ['Laryngeal Cancer', 'Nursing']}, 'descriptionModule': {'briefSummary': 'To explore the effect of perioperative ERAS based nursing model on the hope level and recovery of patients with laryngeal cancer.', 'detailedDescription': '200 patients who were diagnosed with laryngeal cancer and received total or partial laryngectomy were included. They were allocated into experimental and control group. Patients in experimental group were given ERAS based nursing intervention. Control group were given routine nursing intervention. Compare hope level, postoperative recovery, complication between two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were confirmed as laryngeal cancer by CT scan.\n* Patients were given total or partial laryngectomy.\n\nExclusion Criteria:\n\n* Unconscious or psychiatric patients.\n* Patients with distant metastasis or recurrence of cancer\n* Patients with coagulation dysfunction\n* Patients with severe cardiac, hepatic or renal dysfunction.'}, 'identificationModule': {'nctId': 'NCT04174950', 'briefTitle': 'Perioperative ERAS Based Nursing Intervention for Laryngeal Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Effect of Perioperative ERAS Based Nursing Intervention on Hope Level of Patients With Laryngeal Cancer', 'orgStudyIdInfo': {'id': '2018-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Routine perioperative nursing intervention', 'interventionNames': ['Other: Routine nursing care']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'Perioperative ERAS Based Nursing Model', 'interventionNames': ['Other: Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing Model']}], 'interventions': [{'name': 'Routine nursing care', 'type': 'OTHER', 'description': 'routine perioperative nursing intervention, including intensive observation of vital signs, preoperative education, postoperative communication and instruction on diet. NPO after the dinner one day before operation. Patients are instructed to NPO 3 days after surgery and patients should stay on the bed for 3 days. Urinary catheter is always kept for 48 hours or more.', 'armGroupLabels': ['control group']}, {'name': 'Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing Model', 'type': 'OTHER', 'description': 'Establish ERAS nursing team and formulate ERAS nursing intervention. Nothing by mouth (NPO) 6 hours before operation and no water 4 hours before operation. Patients are given fluid food 24 hours after surgery. Urinary catheter is removed within 24 hours after surgery and encourage patient to mobile 24 hours after surgery. Give support to pain control and psychological support. Intensive observation of vital signs, preoperative education, postoperative communication and instruction on diet were also given to patients.', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0571', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuefei Yu, Bachelor', 'role': 'CONTACT', 'email': '2190049@zju.edu.cn', 'phone': '13757119590'}], 'facility': 'Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xuefei Yu, bachelor', 'role': 'CONTACT', 'email': '2190049@zju.edu.cn', 'phone': '13757119590'}], 'overallOfficials': [{'name': 'Xuefei Yu, bachelor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Zhejiang University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Nurse', 'investigatorFullName': 'yuxuefei', 'investigatorAffiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}}}}