Trial record 9 of 27 for:    "Abdominal Abscess"

Intraoperative Fluid Management in Laparoscopic Bariatric Surgery

This study has been completed.
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00905502
First received: May 17, 2009
Last updated: May 19, 2009
Last verified: May 2009
  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?

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • postoperative complications: mortality and morbidity (including readmissions) [ Time Frame: 30 postoperative days (PODs) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00905502

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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:
Abdominal Abscess
Abscess
Acidosis
Hemorrhage
Obesity
Obesity, Morbid
Vomiting
Suppuration
Infection
Inflammation
Pathologic Processes
Acid-Base Imbalance
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014