Intraoperative Fluid Management in Laparoscopic Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT00905502|
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : May 20, 2009
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity Acidosis Intra-Abdominal Abscess Hemorrhage Reflux Vomiting||Drug: Lactated Ringer's solution||Not Applicable|
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.
Several 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.
We 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).
Patients 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.
The 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intraoperative Fluid Management in Laparoscopic Bariatric Surgery - Does it Make a Difference?|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Experimental: 1: Restricted protocol (RG) group
Received 4 ml/kg•hr of Lactated Ringer's solution (RL) throughout the intra-operative period.
Drug: Lactated Ringer's solution
Patients in the RG received 4 ml/kg•hr of Lactated Ringer's solution (RL) throughout the intra-operative period
Other Name: low fluid volume
Active Comparator: 2: Liberal protocol (LG) group
Received 10 ml/kg•hr of RL solution intraoperatively.
Drug: Lactated Ringer's solution
patients in the LG received 10 ml/kg•hr of RL solution intraoperatively
Other Name: high fluid volume
- postoperative complications: mortality and morbidity (including readmissions) [ Time Frame: 30 postoperative days (PODs) ]
- GI recovery: time until the patient resumed drinking and consuming soft food [ Time Frame: 3 PODs ]
- length of hospital stay [ Time Frame: postoperative period ]
- differences in hematocrit, creatinine concentrations and oxygen saturation in the first and third postoperative days and with discharge [ Time Frame: primary hospitalization ]
- the number of patients receiving transfusion of blood and blood products [ Time Frame: 3 PODs ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905502
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Study Chair:||Idit Matot, MD||Tel-Aviv Sourasky Medical Center|
|Principal Investigator:||Andrei Keidar, MD||Hadassa medical organization|