Morbid Obesity Clinical Trial
Official title:
Intraoperative Fluid Management in Laparoscopic Bariatric Surgery - Does it Make a Difference?
Verified date | May 2009 |
Source | Tel-Aviv Sourasky Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 107 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Organization | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center |
Israel,
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. Review. Erratum in: JAMA. 2005 Apr 13;293(14):1728. — View 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. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative complications: mortality and morbidity (including readmissions) | 30 postoperative days (PODs) | Yes | |
Secondary | GI recovery: time until the patient resumed drinking and consuming soft food | 3 PODs | No | |
Secondary | length of hospital stay | postoperative period | Yes | |
Secondary | differences in hematocrit, creatinine concentrations and oxygen saturation in the first and third postoperative days and with discharge | primary hospitalization | Yes | |
Secondary | the number of patients receiving transfusion of blood and blood products | 3 PODs | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03657927 -
A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients
|
N/A | |
Recruiting |
NCT04934826 -
Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese Patients After the Roux Y Gastric Bypass
|
N/A | |
Completed |
NCT03181347 -
The Microbiology of Bariatric Surgery
|
N/A | |
Completed |
NCT03886870 -
Obesity, Lifestyle and Work Intervention
|
N/A | |
Active, not recruiting |
NCT04433338 -
The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery
|
N/A | |
Completed |
NCT03553849 -
Utilization of Very Low Calorie Diet in Obese General Surgery Patients
|
N/A | |
Completed |
NCT05854875 -
Diabetes Remission After RYGBP and RYGBP With Fundus Resection
|
N/A | |
Not yet recruiting |
NCT03203161 -
Registry on Obesity Surgery in Adolescents
|
||
Not yet recruiting |
NCT03601273 -
Bariatric Embolization Trial for the Obese Nonsurgical
|
Phase 1 | |
Recruiting |
NCT02129296 -
Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01564732 -
Multicenter Prospective Randomized Controlled Trial of Plicated Laparoscopic Adjustable Gastric Banding
|
N/A | |
Completed |
NCT02033265 -
Ultrasound-Guided Axillary Brachial Plexus Block: Influence of Obesity
|
||
Completed |
NCT01963637 -
Gastric Volumetry by Gastric Tomodensitometry With Gas
|
N/A | |
Not yet recruiting |
NCT01652105 -
Randomized Trial of Preoperative Diets Before Bariatric Surgery
|
N/A | |
Completed |
NCT01955993 -
Fentanyl Metabolism in Obese Adolescents
|
N/A | |
Completed |
NCT01149512 -
Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program
|
N/A | |
Terminated |
NCT01759550 -
Prospective Case-Series of Ligasure Advance Pistol Grip and LigaSure Blunt Tip
|
||
Recruiting |
NCT01685177 -
Single Anastomosis Duodeno-Ileal Bypass vs Standard Duodenal Switch as a Second Step After Sleeve Gastrectomy in the Super-Morbid Obese Patient
|
N/A | |
Terminated |
NCT01041261 -
Effects of a Novel Dietary Intervention on Body Composition After Laparoscopic Gastric Bypass Surgery
|
N/A | |
Completed |
NCT02414893 -
Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients
|
N/A |