Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT00905502
Status:
COMPLETED
Last Update Posted:
2009-05-20
First Post:
2009-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Fluid Management in Laparoscopic Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D018784', 'term': 'Abdominal Abscess'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-19', 'studyFirstSubmitDate': '2009-05-17', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative complications: mortality and morbidity (including readmissions)', 'timeFrame': '30 postoperative days (PODs)'}], 'secondaryOutcomes': [{'measure': 'GI recovery: time until the patient resumed drinking and consuming soft food', 'timeFrame': '3 PODs'}, {'measure': 'length of hospital stay', 'timeFrame': 'postoperative period'}, {'measure': 'differences in hematocrit, creatinine concentrations and oxygen saturation in the first and third postoperative days and with discharge', 'timeFrame': 'primary hospitalization'}, {'measure': 'the number of patients receiving transfusion of blood and blood products', 'timeFrame': '3 PODs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'fluid management', 'postoperative complications', 'bariatric surgery', 'hemostasis'], 'conditions': ['Morbid Obesity', 'Acidosis', 'Intra-Abdominal Abscess', 'Hemorrhage', 'Reflux', 'Vomiting']}, 'referencesModule': {'references': [{'pmid': '15199035', 'type': 'BACKGROUND', 'citation': 'Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.'}, {'pmid': '15479938', 'type': 'BACKGROUND', 'citation': 'Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.'}, {'pmid': '17036576', 'type': 'BACKGROUND', 'citation': 'McGlinch BP, Que FG, Nelson JL, Wrobleski DM, Grant JE, Collazo-Clavell ML. Perioperative care of patients undergoing bariatric surgery. Mayo Clin Proc. 2006 Oct;81(10 Suppl):S25-33. doi: 10.1016/s0025-6196(11)61178-6.'}]}, 'descriptionModule': {'briefSummary': "The objective of this study is to evaluate the effects of 'high' versus 'low' volume intraoperative fluid administration (Ringer Lactate, RL) on intra- and postoperative parameters, in obese patients undergoing laparoscopic bariatric surgery (i.e., gastric bypass), in order to establish evidence-based data for perioperative fluid management in this patient population. Based on their experience as well as several reports in the literature, the investigators hypothesized that a restrictive approach to intraoperative hydration will reduce the incidence of postoperative complications and the recovery time of gastrointestinal (GI) function, and shorten hospital stay.", 'detailedDescription': "Obesity, a chronic disease that is increasing in prevalence in adults, adolescents, and children, is now considered to be a global epidemic. The prevalence of obesity has increased markedly in the last two decades and it is now considered to be a global epidemic. In the US 65% of all adults are overweight or obese and 30% are obese. Surgery is the only effective treatment for morbid obesity, and open Roux-en-Y gastric bypass (RYGB) has become the procedure of choice for these patients.\n\nSeveral studies on perioperative fluid management have reported that 'high volume' regimens may result in overhydration having deleterious effects on cardiac and pulmonary function, recovery of GI motility, tissue oxygenation, wound healing and coagulation. Most reported randomized trials suggest that perioperative fluid management has evolved to a more restricted regimen. Specifically, restricted fluid volumes applied during bariatric procedures have been shown to reduce perioperative complications (pulmonary dysfunction, hypoxia, nausea and vomiting), thereby decrease the prevalence of morbidity and mortality associated with such procedures.\n\nWe wished to evaluate in a prospective randomized study the impact of fluid management on perioperative parameters in patients undergoing a variety of laparoscopic bariatric procedures: Roux-Y Gastric Bypass (LRYGB), Biliopancreatic Diversion with Duodenal Switch (LDS), or Sleeve Gastrectomy (LSG).\n\nPatients were randomly allocated to one of two groups receiving either 4 ml/kg•hr or 10 ml/kg•hr of RL solution throughout the intra-operative period.\n\nThe primary endpoints of the study included: mortality rate and incidence of postoperative complications, during primary hospitalization. Readmission rate to the hospital within 30 days of surgery was another primary endpoint. The secondary endpoints included time till the patient resumed drinking and consuming soft food, length of hospital stay, differences in hematocrit, creatinine concentrations and oxygen saturation in the first and third postoperative days and with discharge, and the number of patients receiving transfusion of blood and blood products."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients ( \\>18 years) with an American Society of Anesthesiology physical status of I-III who were presenting for laparoscopic bariatric surgery, were prospectively studied.\n* Patients were considered eligible if they had a BMI \\> 40, or \\> 35 and at least one comorbid condition and were scheduled to undergo one of the following laparoscopic operations:\n\n * Roux-Y Gastric Bypass (LRYGB)\n * Biliopancreatic Diversion with Duodenal Switch (LDS), or\n * Sleeve Gastrectomy (LSG).\n\nExclusion Criteria:\n\n* Patients aged younger than 18 years.\n* Patients with renal dysfunction (creatinine \\> 50% upper limit of normal value).\n* Congestive heart failure.'}, 'identificationModule': {'nctId': 'NCT00905502', 'briefTitle': 'Intraoperative Fluid Management in Laparoscopic Bariatric Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Intraoperative Fluid Management in Laparoscopic Bariatric Surgery - Does it Make a Difference?', 'orgStudyIdInfo': {'id': 'TASMC-09-IM-38590207-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: Restricted protocol (RG) group', 'description': "Received 4 ml/kg•hr of Lactated Ringer's solution (RL) throughout the intra-operative period.", 'interventionNames': ["Drug: Lactated Ringer's solution"]}, {'type': 'ACTIVE_COMPARATOR', 'label': '2: Liberal protocol (LG) group', 'description': 'Received 10 ml/kg•hr of RL solution intraoperatively.', 'interventionNames': ["Drug: Lactated Ringer's solution"]}], 'interventions': [{'name': "Lactated Ringer's solution", 'type': 'DRUG', 'otherNames': ['low fluid volume'], 'description': "Patients in the RG received 4 ml/kg•hr of Lactated Ringer's solution (RL) throughout the intra-operative period", 'armGroupLabels': ['1: Restricted protocol (RG) group']}, {'name': "Lactated Ringer's solution", 'type': 'DRUG', 'otherNames': ['high fluid volume'], 'description': 'patients in the LG received 10 ml/kg•hr of RL solution intraoperatively', 'armGroupLabels': ['2: Liberal protocol (LG) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Idit Matot, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tel-Aviv Sourasky Medical Center'}, {'name': 'Andrei Keidar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassa medical organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Prof Idit Matot', 'oldOrganization': 'Sourasky medical center'}}}}