Intraoperative Fluid Management in Laparoscopic Bariatric Surgery

Not Applicable

Completed

• Conditions: Morbid Obesity; Hemorrhage; Reflux; Acidosis; Intra-Abdominal Abscess; Vomiting
• Interventions: Drug: Lactated Ringer's solution

• Registration Number: NCT00905502
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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.

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-05
• Study First Submitted: 2009-05-17
• Study First Submitted QC: 2009-05-19
• Last Update Submitted: 2009-05-19
• Study First Posted: 2009-05-20
• Last Update Posted: 2009-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Restricted protocol (RG) group	Lactated Ringer's solution	Received 4 ml/kg•hr of Lactated Ringer's solution (RL) throughout the intra-operative period.
2: Liberal protocol (LG) group	Lactated Ringer's solution	Received 10 ml/kg•hr of RL solution intraoperatively.

Primary Outcome Measures

Name	Time	Method
postoperative complications: mortality and morbidity (including readmissions)	30 postoperative days (PODs)

Secondary Outcome Measures

Name	Time	Method
length of hospital stay	postoperative period
GI recovery: time until the patient resumed drinking and consuming soft food	3 PODs
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

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel