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Intraoperative Fluid Management in Laparoscopic Bariatric Surgery

Primary Purpose

Morbid Obesity, Acidosis, Intra-Abdominal Abscess

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Lactated Ringer's solution
Lactated Ringer's solution
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Obesity, fluid management, postoperative complications, bariatric surgery, hemostasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1: Restricted protocol (RG) group

2: Liberal protocol (LG) group

Arm Description

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

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

Outcomes

Primary Outcome Measures

postoperative complications: mortality and morbidity (including readmissions)

Secondary Outcome Measures

GI recovery: time until 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
the number of patients receiving transfusion of blood and blood products

Full Information

First Posted
May 17, 2009
Last Updated
May 19, 2009
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00905502
Brief Title
Intraoperative Fluid Management in Laparoscopic Bariatric Surgery
Official Title
Intraoperative Fluid Management in Laparoscopic Bariatric Surgery - Does it Make a Difference?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Acidosis, Intra-Abdominal Abscess, Hemorrhage, Reflux, Vomiting
Keywords
Obesity, fluid management, postoperative complications, bariatric surgery, hemostasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Restricted protocol (RG) group
Arm Type
Experimental
Arm Description
Received 4 ml/kg•hr of Lactated Ringer's solution (RL) throughout the intra-operative period.
Arm Title
2: Liberal protocol (LG) group
Arm Type
Active Comparator
Arm Description
Received 10 ml/kg•hr of RL solution intraoperatively.
Intervention Type
Drug
Intervention Name(s)
Lactated Ringer's solution
Other Intervention Name(s)
low fluid volume
Intervention Description
Patients in the RG received 4 ml/kg•hr of Lactated Ringer's solution (RL) throughout the intra-operative period
Intervention Type
Drug
Intervention Name(s)
Lactated Ringer's solution
Other Intervention Name(s)
high fluid volume
Intervention Description
patients in the LG received 10 ml/kg•hr of RL solution intraoperatively
Primary Outcome Measure Information:
Title
postoperative complications: mortality and morbidity (including readmissions)
Time Frame
30 postoperative days (PODs)
Secondary Outcome Measure Information:
Title
GI recovery: time until the patient resumed drinking and consuming soft food
Time Frame
3 PODs
Title
length of hospital stay
Time Frame
postoperative period
Title
differences in hematocrit, creatinine concentrations and oxygen saturation in the first and third postoperative days and with discharge
Time Frame
primary hospitalization
Title
the number of patients receiving transfusion of blood and blood products
Time Frame
3 PODs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Idit Matot, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andrei Keidar, MD
Organizational Affiliation
Hadassa medical organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
15199035
Citation
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.
Results Reference
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PubMed Identifier
15479938
Citation
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.
Results Reference
background
PubMed Identifier
17036576
Citation
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.
Results Reference
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Intraoperative Fluid Management in Laparoscopic Bariatric Surgery

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