Intraoperative Fluid Management in Laparoscopic Bariatric Surgery
Condition: Morbid Obesity; Acidosis; Intra-Abdominal Abscess; Hemorrhage; Reflux; Vomiting
MeSH terms: Abdominal Abscess; Obesity, Morbid; Acidosis; Hemorrhage; Vomiting
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Lactated Ringer's solution; Lactated Ringer's solution
Intervention type(s): Drug; Drug
Intervention description(s): Patients in the RG received 4 ml/kg•hr of Lactated Ringer's solution (RL) throughout the intra-operative period; patients in the LG received 10 ml/kg•hr of RL solution intraoperatively
Other intervention name(s): low fluid volume; high fluid volume
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; fluid management; postoperative complications; bariatric surgery; hemostasis