Intraoperative Fluid Management in Laparoscopic Bariatric Surgery

Intraoperative Fluid Management in Laparoscopic Bariatric Surgery - Does it Make a Difference?

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Vomiting; Morbid Obesity; Intra-Abdominal Abscess; Acidosis; Reflux
• Intervention / Treatment: Drug: Lactated Ringer's solution; Drug: Lactated Ringer's solution

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

• 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:

  • Roux-Y Gastric Bypass (LRYGB)
  • Biliopancreatic Diversion with Duodenal Switch (LDS), or
  • Sleeve Gastrectomy (LSG).

Exclusion Criteria:

• Patients aged younger than 18 years.
• Patients with renal dysfunction (creatinine > 50% upper limit of normal value).
• Congestive heart failure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: low fluid volume; Drug: Lactated Ringer's solution; patients in the LG received 10 ml/kg•hr of RL solution intraoperatively; Other Names: high 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 RG received 4 ml/kg•hr of Lactated Ringer's solution (RL) throughout the intra-operative period; Other Names: low fluid volume; Drug: Lactated Ringer's solution; patients in the LG received 10 ml/kg•hr of RL solution intraoperatively; Other Names: high fluid volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
postoperative complications: mortality and morbidity (including readmissions)	30 postoperative days (PODs)

Secondary Outcome Measures

Outcome Measure	Time Frame
GI recovery: time until the patient resumed drinking and consuming soft food	3 PODs
length of hospital stay	postoperative period
differences in hematocrit, creatinine concentrations and oxygen saturation in the first and third postoperative days and with discharge	primary hospitalization
the number of patients receiving transfusion of blood and blood products	3 PODs

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Andrei Keidar, MD, Hadassa Medical Organization

Publications and helpful links

General Publications

• 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. Erratum In: JAMA. 2005 Apr 13;293(14):1728.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: May 17, 2009
• First Submitted That Met QC Criteria: May 19, 2009
• First Posted (ESTIMATE): May 20, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 20, 2009
• Last Update Submitted That Met QC Criteria: May 19, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Obesity; bariatric surgery; hemostasis; postoperative complications; fluid management
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Infections; Signs and Symptoms, Digestive; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Suppuration; Obesity; Acid-Base Imbalance; Abscess; Vomiting; Hemorrhage; Obesity, Morbid; Abdominal Abscess; Acidosis; Pharmaceutical Solutions
• Other Study ID Numbers: TASMC-09-IM-38590207-CTIL