Intraoperative Fluid Management in Laparoscopic Bariatric Surgery

NCT ID: NCT00905502

Last Updated: 2009-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-12-31

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.

Conditions

Morbid Obesity; Acidosis; Intra-Abdominal Abscess; Hemorrhage; Reflux; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1: Restricted protocol (RG) group

Received 4 ml/kg•hr of Lactated Ringer's solution (RL) throughout the intra-operative period.

Group Type: EXPERIMENTAL

Lactated Ringer's solution

Intervention Type: DRUG

Patients in the RG received 4 ml/kg•hr of Lactated Ringer's solution (RL) throughout the intra-operative period

2: Liberal protocol (LG) group

Received 10 ml/kg•hr of RL solution intraoperatively.

Group Type: ACTIVE_COMPARATOR

Lactated Ringer's solution

Intervention Type: DRUG

patients in the LG received 10 ml/kg•hr of RL solution intraoperatively

Interventions

Lactated Ringer's solution

Patients in the RG received 4 ml/kg•hr of Lactated Ringer's solution (RL) throughout the intra-operative period

Intervention Type: DRUG

Lactated Ringer's solution

patients in the LG received 10 ml/kg•hr of RL solution intraoperatively

Intervention Type: DRUG

Other Intervention Names

low fluid volume; high fluid volume

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sourasky medical center

Principal Investigators

Idit Matot, MD

Role: STUDY_CHAIR

Tel-Aviv Sourasky Medical Center

Andrei Keidar, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassa medical organization

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 15199035 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15479938 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17036576 (View on PubMed)

Other Identifiers

TASMC-09-IM-38590207-CTIL

Identifier Type: -

Identifier Source: org_study_id