Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-02-24 @ 10:54 AM
Study NCT ID:
NCT02991092
Status:
UNKNOWN
Last Update Posted:
2016-12-13
First Post:
2016-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer.（FTSlapCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-03-04', 'releaseDate': '2020-02-20'}], 'estimatedResultsFirstSubmitDate': '2020-02-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055103', 'term': 'Hypodermoclysis'}], 'ancestors': [{'id': 'D055104', 'term': 'Infusions, Subcutaneous'}, {'id': 'D007263', 'term': 'Infusions, Parenteral'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005440', 'term': 'Fluid Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-08', 'studyFirstSubmitDate': '2016-11-30', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'inferior vena cava diameter（mm）', 'timeFrame': 'Twenty-fourth hours after operation and before operation'}, {'measure': 'stat body height（m）', 'timeFrame': 'Twenty-fourth hours after operation and before operation'}, {'measure': 'body weight（Kg）', 'timeFrame': 'Twenty-fourth hours after operation and before operation'}], 'primaryOutcomes': [{'measure': 'recovery time of intestinal function', 'timeFrame': 'within the first 30 days (plus or minus 3 days) after surgery'}], 'secondaryOutcomes': [{'measure': 'TNF-alpha', 'timeFrame': 'the first day to the forth day After the operation'}, {'measure': 'CRP[=C reactive protein]ba', 'timeFrame': 'the first day to the forth day After the operation'}, {'measure': 'IL-10[=interleukin-10]', 'timeFrame': 'the first day to the forth day After the operation'}, {'measure': 'BNP[=type B natriuretic peptide]', 'timeFrame': 'the first day to the forth day After the operation'}, {'measure': 'hospitalization time after operation（day）', 'timeFrame': 'within the first 30 days (plus or minus 3 days) after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colon carcinoma', 'liquid treatment', 'fast-track surgery'], 'conditions': ['Colon Carcinoma']}, 'descriptionModule': {'briefSummary': 'To compare the influence of two different fluid administration strategies on the clinical efficacy of patients with colorectal carcinoma during the fast-track surgery.', 'detailedDescription': 'Patients that were diagnosed with colorectal carcinoma by the First Hospital of Jilin University and were scheduled to undergo the laparoscopic surgery were prospectively included and divided into the experimental group and the control group with the random number method. After surgery, patients in the experiment group were provided with intravenous fluid administration at 1.0ml/Kg/h and encouraged to take food and drink water early after surgery, and the intravenous fluid administration was stopped immediately when the oral intake was more than 1500ml/h; patients in the control group strictly followed the fasting and were provided with the intravenous fluid administration according to "Total amount of fluid = physiological requirement + additional loss (fever + gastrointestinal decompression) + amount lost" until their intestinal function completely recovered. The blood volume change indicators (heart rate, mean arterial pressure, oxyhemoglobin saturation, inferior vena cava diameter /body surface area (VCD), intra-abdominal pressure, specific gravity of urine, BNP, etc.) and inflammation indicators (CRP, IL-6, TNF-a) of the two groups of patients were observed and a comparison was made of the recovery time of intestinal function, incidence of complications, hospitalization time after operation and hospitalization expenses of the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. the age of 18-70 years old\n2. the pathological diagnosis of colon cancer patients\n3. no surgical intervention.\n\nExclusion Criteria:\n\n1. patients with heart, lung, liver, renal function were significantly abnormal\n2. body mass index kg \\>35 / m2\n3. pregnancy\n4. sepsis or systemic inflammatory response syndrome patients.\n5. patients with severe malnutrition.'}, 'identificationModule': {'nctId': 'NCT02991092', 'briefTitle': 'The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer.（FTSlapCC)', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer After Laparoscopic Surgery.', 'orgStudyIdInfo': {'id': 'FTSlapCC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the experimental group', 'description': 'After surgery, patients in the experiment group were provided with intravenous fluid administration at 1.0ml/Kg/h and encouraged to take food and drink water early after surgery, and the intravenous fluid administration was stopped immediately when the oral intake was more than 1500ml/h', 'interventionNames': ['Procedure: fluid administration']}, {'type': 'OTHER', 'label': 'the control group', 'description': 'patients in the control group strictly followed the fasting and were provided with the intravenous fluid administration according to "Total amount of fluid = physiological requirement + additional loss (fever + gastrointestinal decompression) + amount lost" until their intestinal function completely recovered.', 'interventionNames': ['Procedure: fluid administration']}], 'interventions': [{'name': 'fluid administration', 'type': 'PROCEDURE', 'description': 'After surgery, patients in the experiment group were provided with intravenous fluid administration at 1.0ml/Kg/h and encouraged to take food and drink water early after surgery, and the intravenous fluid administration was stopped immediately when the oral intake was more than 1500ml/h; patients in the control group strictly followed the fasting and were provided with the intravenous fluid administration according to "Total amount of fluid = physiological requirement + additional loss (fever + gastrointestinal decompression) + amount lost" until their intestinal function completely recovered.', 'armGroupLabels': ['the control group', 'the experimental group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shengk Qiu, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'qiusk7009@sina.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quan Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy chief physician', 'investigatorFullName': 'Quan Wang', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-02-20', 'type': 'RELEASE'}, {'date': '2020-03-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Quan Wang, Director of Gastrointestinal Surgery, The First Hospital of Jilin University'}}}}