Intraoperative Fluid Management in Laparoscopic Bariatric Surgery

NCT00905502 | Completed

• 1 other identifier: TASMC-09-IM-38590207-CTIL
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Obesity; fluid management; postoperative complications; bariatric surgery; hemostasis

Outcome Measures

Primary Outcomes (1)

• postoperative complications: mortality and morbidity (including readmissions)

  30 postoperative days (PODs)

Secondary Outcomes (4)

• 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

Study Arms (2)

1: Restricted protocol (RG) group

EXPERIMENTAL

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

Drug: Lactated Ringer's solution

2: Liberal protocol (LG) group

ACTIVE COMPARATOR

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

Drug: Lactated Ringer's solution

Interventions

Lactated Ringer's solution DRUG

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

Also known as: low fluid volume

1: Restricted protocol (RG) group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Related Publications (3)

• 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.

  PMID: 15199035 BACKGROUND

• 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.

  PMID: 15479938 BACKGROUND

• 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.

  PMID: 17036576 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Acidosis; Abdominal Abscess; Hemorrhage; Gastroesophageal Reflux; Vomiting; Obesity; Postoperative Complications

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Acid-Base Imbalance; Metabolic Diseases; Abscess; Suppuration; Infections; Pathologic Processes; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Idit Matot, MD

  Tel-Aviv Sourasky Medical Center

  STUDY CHAIR

• Andrei Keidar, MD

  Hadassa medical organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 17, 2009
• First Posted: May 20, 2009
• Study Start: April 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 20, 2009

Record last verified: 2009-05

Locations

IL (1)