Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-31 @ 7:55 AM
Study NCT ID:
NCT04467359
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2020-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Rapid Rehabilitation Nursing in Perioperative Rehabilitation of Knee Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The subjects were randomly divided into the experimental group and the control group. The control group received conventional rehabilitation nursing during the perioperative period, while the experimental group received ERAS intervention. The differences between the two groups in postoperative pain degree (NRS0-10) comfort level (Likert 1-5) and rehabilitation completion Range of motion(ROM) score were compared. The safety index was the occurrence of postoperative complications such as nausea, vomiting, dizziness, headache and urinary retention, and the occurrence of postoperative complications such as hypothermia after lower extremity deep venous thrombosis (preoperative and postoperative comparison of ESR CRP and procalcitonin indexes in blood routine)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-09', 'studyFirstSubmitDate': '2020-06-28', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-care ability score', 'timeFrame': '1 day before operation', 'description': 'Barthel Index:Barthel index is scored from 0 to 100. A score of 100 indicates that the patient has a good function in basic daily activities. He/she does not need help from others. He/she is able to control urine and urine, eat, dress, transfer to bed and chair, bathe, walk for at least one block, and can go up and down stairs. A score of 0 indicates poor functioning, lack of independence, and need help with all aspects of daily life. According to the score of Barthel index, the ability of daily activities was divided into three levels: good, medium and poor \\>. 60 was classified as good. 60 to 41 is medium. Have moderate dysfunction and need great help to complete daily activities; ≤40 is classified as poor, with severe dysfunction, most daily activities cannot be completed or need to be attended to by others.'}, {'measure': 'Self-care ability score', 'timeFrame': 'Postoperative 1 day', 'description': 'Barthel Index:Barthel index is scored from 0 to 100. A score of 100 indicates that the patient has a good function in basic daily activities. He/she does not need help from others. He/she is able to control urine and urine, eat, dress, transfer to bed and chair, bathe, walk for at least one block, and can go up and down stairs. A score of 0 indicates poor functioning, lack of independence, and need help with all aspects of daily life. According to the score of Barthel index, the ability of daily activities was divided into three levels: good, medium and poor \\>. 60 was classified as good. 60 to 41 is medium. Have moderate dysfunction and need great help to complete daily activities; ≤40 is classified as poor, with severe dysfunction, most daily activities cannot be completed or need to be attended to by others.'}, {'measure': 'Degree of postoperative pain', 'timeFrame': 'Postoperative 1 day', 'description': 'Numerical Rating Scale(NRS )score:0 means no pain, 10 means the most severe pain imaginable, and the higher the score, the more severe the pain'}, {'measure': 'Comfort level', 'timeFrame': 'Postoperative 1 day', 'description': 'Likert 1-5 score:0 means very uncomfortable, 10 means very comfortable, and the higher the score, the higher the comfort'}, {'measure': 'Rehabilitation Completion', 'timeFrame': '2 weeks after discharged', 'description': 'Range of motion(ROM):Use a square to measure the Angle of motion'}, {'measure': 'Rehabilitation Completion', 'timeFrame': '4 weeks after discharged', 'description': 'Range of motion(ROM):Use a square to measure the Angle of motion'}, {'measure': 'Rehabilitation Completion', 'timeFrame': '8 weeks after discharged', 'description': 'Range of motion(ROM):Use a square to measure the Angle of motion'}, {'measure': 'Rehabilitation Completion', 'timeFrame': '12 weeks after discharged', 'description': 'Range of motion(ROM):Use a square to measure the Angle of motion'}], 'secondaryOutcomes': [{'measure': 'adverse reaction', 'timeFrame': 'postoperative 1 day', 'description': 'Postoperative nausea, vomiting, dizziness, headache, urinary retention and other non-reaction occurred'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nursing', 'Enhanced Recovery After Surgery（ERAS）'], 'conditions': ['Knee Arthroscopy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to apply the concept of rapid rehabilitation nursing in the perioperative period of knee arthroscopy, to make up for the gap in this field, to provide reference basis for the general colleagues, promote the development of perioperative rapid rehabilitation nursing of knee arthroscopy, accelerate the rehabilitation of patients.', 'detailedDescription': 'This study aims to apply rapid rehabilitation nursing concept to the arthroscopic perioperative nursing, used to make up for the blank in this field, provides the reference for the overwhelming majority of peer, prompt the arthroscopic perioperative rehabilitation nursing development, accelerate the patient rehabilitation in January 2020 - December 2020 in Beijing a third rate sports medicine hospital be in hospital, to line the arthroscopic surgery patients as the research object, adopt the method of prospective, randomized, controlled in 220 patients. Inclusion criteria: \\< 60 age 18 years old, patients with informed consent and voluntary participation in arthroscopic anterior cruciate ligament reconstruction under external anesthesia were excluded from this study: patients with mental system diseases or communication disorders; Patients with metabolic diseases such as diabetes; Patients who could not quit smoking and drinking alcohol before surgery as required; Patients with gastrointestinal tract disease research object were randomly divided into experimental group and control group, control group given conventional perioperative nursing, the experimental group to implement rapid rehabilitation program, the specific implementation process, see table 1 and table 2, compare two groups of preoperative postoperative self-care ability score (Barthel index) 、 the degree of postoperative pain numerical rating scale (NRS 0-10 score) 、the degree of comfort (Likert 1-5 rating score) and rehabilitation completion -Range of motion(ROM) score difference; The safety index was the occurrence of postoperative complications such as nausea, vomiting, dizziness, headache and urinary retention, and the occurrence of postoperative complications such as hypothermia after lower extremity deep venous thrombosis (preoperative and postoperative comparison of erythrocyte sedimentation rate(ESR)、C-reactive protein（CRP） and procalcitonin indexes in blood routine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Arthroscopic anterior cruciate ligament reconstruction was performed under epidural anesthesia\n* The patients consented and volunteered to participate in this study\n\nExclusion Criteria:\n\n* Patients with mental disorders or communication disorders\n* Patients with metabolic diseases such as diabetes\n* Patients who could not quit smoking and drinking alcohol before surgery as required\n* Patients with gastrointestinal disorders\n* Patients who are not under epidural anesthesia'}, 'identificationModule': {'nctId': 'NCT04467359', 'briefTitle': 'Application of Rapid Rehabilitation Nursing in Perioperative Rehabilitation of Knee Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Application of Rapid Rehabilitation Nursing in Perioperative Rehabilitation of Knee Arthroscopy', 'orgStudyIdInfo': {'id': '2018180520'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The experimental group', 'description': 'ERAS intervention group', 'interventionNames': ['Other: ERAS', 'Other: Perioperative routine rehabilitation nursing']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'The control group', 'description': 'Sports medicine rehabilitation nursing group', 'interventionNames': ['Other: Perioperative routine rehabilitation nursing']}], 'interventions': [{'name': 'ERAS', 'type': 'OTHER', 'description': 'Optimize physical conditions; Fasting solid diet 6h before surgery, fasting clear fluid 2 h before surgery; If there is no chief complaint of dizziness, nausea or other discomfort after the operation, warm water (no more than 100ml) can be immediately drunk. Pain management; Encourage patients to engage in early activities under the premise of effective pain control; If no dural puncture and other complications occur, the patient has no chief complaints of headache, dizziness, nausea and other discomfort, and there is no need to lie supine, the comfortable position such as semi-supine lateral supine position can be taken immediately (avoid 90-degree upright position for patients with hip joint); Prevention of thrombosis; Prevention and treatment of nausea and vomiting; Follow-up was conducted at 4 weeks, 8 weeks and 12 weeks after the operation.', 'armGroupLabels': ['The experimental group']}, {'name': 'Perioperative routine rehabilitation nursing', 'type': 'OTHER', 'description': "Fasting and water deprivation at 12 o 'clock on the first day before surgery; Fasting water 6-8 hours after surgery; Lie flat on your pillow for 6 hours; Get out of bed activity 1 day after operation", 'armGroupLabels': ['The control group', 'The experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Peking Universitu 3rd Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xin Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}