Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-23 @ 4:24 AM
Study NCT ID:
NCT02533193
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2015-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-13', 'studyFirstSubmitDate': '2015-08-11', 'studyFirstSubmitQcDate': '2015-08-22', 'lastUpdatePostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-operative hospital stay', 'timeFrame': 'up to 4 weeks after surgery', 'description': 'participants will be followed for the duration of hospital stay, an expected average of 6 days'}, {'measure': 'Recovering Rate', 'timeFrame': '6 days after surgery', 'description': '1. No major complication\n2. Tolerance of semiliquid diet\n3. Normal activity\n4. Good pain control with analgesic-free or oral analgesics.'}], 'secondaryOutcomes': [{'measure': 'Time to functional recovery (days from operation to functional recovery)', 'timeFrame': 'up to 4 weeks after surgery', 'description': 'Normal or decreasing serum bilirubin Good pain control with oral analgesia only Tolerance of solid food No intravenous fluids Mobile independently or at the preoperative level All of the above is functional recovery.'}, {'measure': 'cost of hospitalization', 'timeFrame': 'up to 1 month after surgery', 'description': 'medical expense'}, {'measure': 'Quality of life', 'timeFrame': 'up to 1 month after surgery', 'description': "EQ-5d health questionnaire and Kolcaba's GCQ (General Comfort Questionnaire), before the operation, on postoperation 1 day, postoperation 3 day, postoperation 5 day, postoperation 1 month"}, {'measure': 'operation time', 'timeFrame': 'the day of surgery'}, {'measure': 'associated cytokines in peripheral blood (IL-6, IL-10 and TNF-α)', 'timeFrame': 'before the operation, on postoperation 1 day, postoperation 2 day, postoperation 4 day', 'description': 'associated cytokines in peripheral blood were tested on preoperation, postoperation Day1, postoperation Day2, postoperation Day4'}, {'measure': 'liver function', 'timeFrame': 'up to 1 month after surgery', 'description': 'liver function were tested on preoperation, postoperation Day1, postoperation Day2, postoperation Day4, postoperation 1 month if PT ≥ 50% and TB ≥ 50 μmol/L， it supports the liver dysfunction.'}, {'measure': 'Visual Analog Score for pain', 'timeFrame': 'up to 5 days after surgery', 'description': 'postoperative 2hours, 6 hours, 1 days, 2 days, 3 days, 4 days and 5 days'}, {'measure': 'Estimated blood loss', 'timeFrame': 'the day of surgery', 'description': 'blood loss during the operation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['enhanced recovery after surgery protocal', 'laparoscopic hepatectomy'], 'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .', 'detailedDescription': 'The ERAS programs has been proved to be a useful solutions in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.\n\nBut few studies reported about the ERAS programs in the laparoscopic hepatectomy.\n\nThe purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* If patients were diagnosed with tumors\n\n 1. Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ\n 2. The tumor location and size do not affect the dissection of hepatic hilar region\n 3. Tumor size less than 10cm\n 4. Without portal vein tumor thrombus\n 5. Without intrahepatic or distant metastasis\n* Partial resection or half liver resection\n* Willingness to participate in the study\n* Able to understand the nature of the study and what will be required of them\n* Body mass index of between 18 and 35\n* Child-Pugh classification of A to B\n* American Society of Anesthesiologists (ASA) grading of I to III\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Unwillingness to participate\n* Inability to give written informed consent\n* Child-Pugh classification of C\n* ASA grading of IV to V\n* Tumor invasion of the inferior vena cava or confluence part of hepatic vein\n* Decompensated liver cirrhosis'}, 'identificationModule': {'nctId': 'NCT02533193', 'briefTitle': 'Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Sir Run Run Shaw Hospital'}, 'officialTitle': 'A Randomized Controlled Trial of Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy', 'orgStudyIdInfo': {'id': 'sirrrsh20150802-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'enhanced recovery after surgery protocal', 'description': 'ERAS perioperative cares patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.', 'interventionNames': ['Procedure: ERAS perioperative cares']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional perioperative cares', 'description': "Conventional perioperative cares patents will be managed by our hospital's critical pathways.", 'interventionNames': ['Procedure: Conventional perioperative cares']}], 'interventions': [{'name': 'ERAS perioperative cares', 'type': 'PROCEDURE', 'description': "1. Patient's preoperative counseling \\& education before surgery\n2. No Bowel preparation\n3. Drug: Oral Carbohydrate Solution (OCS). Take 250ml OCS orally 2 hours before surgery\n4. Fluid restriction \\& Management by pulse contour analysis or transesophageal doppler\n5. Early mobilization\n6. Early oral feeding (postoperative 1 day - liquid diet, 2 days - semifluid diet (SFD), 3 days - normal diet)\n7. Intravenous patient controlled analgesics (no opioids analgesics)\n8. Postoperative Nausea Active Control\n9. No nasogastric tube\n10. No drain insertion\n11. Patients will be discharged at POD#4 if there's no problem", 'armGroupLabels': ['enhanced recovery after surgery protocal']}, {'name': 'Conventional perioperative cares', 'type': 'PROCEDURE', 'description': "1. No Patient's preoperative counseling \\& education before surgery\n2. Bowel preparation\n3. No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery\n4. Conventional Fluid Management by clinical signs (Urine output, heart rate etc.)\n5. Conventional Mobilization\n6. Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD)\n7. IV PCA\n8. Postoperative Nausea Control if needed\n9. No Thromboembolism prophylaxis\n10. No or Low Content Oxygen therapy\n11. Drainage tube insertion if needed", 'armGroupLabels': ['Conventional perioperative cares']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Xiujun Cai', 'investigatorAffiliation': 'Sir Run Run Shaw Hospital'}}}}