Intraoperative Fluid Management in Laparoscopic Bariatric Surgery
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Morbid Obesity Acidosis Intra-Abdominal Abscess Hemorrhage Reflux Vomiting |
Drug: Lactated Ringer's solution |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intraoperative Fluid Management in Laparoscopic Bariatric Surgery - Does it Make a Difference? |
- postoperative complications: mortality and morbidity (including readmissions) [ Time Frame: 30 postoperative days (PODs) ] [ Designated as safety issue: Yes ]
- GI recovery: time until the patient resumed drinking and consuming soft food [ Time Frame: 3 PODs ] [ Designated as safety issue: No ]
- length of hospital stay [ Time Frame: postoperative period ] [ Designated as safety issue: Yes ]
- differences in hematocrit, creatinine concentrations and oxygen saturation in the first and third postoperative days and with discharge [ Time Frame: primary hospitalization ] [ Designated as safety issue: Yes ]
- the number of patients receiving transfusion of blood and blood products [ Time Frame: 3 PODs ] [ Designated as safety issue: Yes ]
| Enrollment: | 107 |
| Study Start Date: | April 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: low 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 LG received 10 ml/kg•hr of RL solution intraoperatively
Other Name: high fluid volume
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Israel | |
| Hadassah Medical Organization | |
| Jerusalem, Israel, 91120 | |
| Study Chair: | Idit Matot, MD | Tel-Aviv Sourasky Medical Center |
| Principal Investigator: | Andrei Keidar, MD | Hadassa medical organization |
More Information
Publications:
| Responsible Party: | Prof Idit Matot, Sourasky medical center |
| ClinicalTrials.gov Identifier: | NCT00905502 History of Changes |
| Other Study ID Numbers: | TASMC-09-IM-38590207-CTIL |
| Study First Received: | May 17, 2009 |
| Last Updated: | May 19, 2009 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
Obesity fluid management postoperative complications bariatric surgery hemostasis |
Additional relevant MeSH terms:
|
Abscess Acidosis Hemorrhage Obesity Obesity, Morbid Vomiting Abdominal Abscess Suppuration Infection Inflammation |
Pathologic Processes Acid-Base Imbalance Metabolic Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Signs and Symptoms, Digestive |
ClinicalTrials.gov processed this record on June 18, 2013