Clinical Trials Logo

Clinical Trial Summary

While laparoscopic sleeve gastrectomy (LSG) has become the most commonly performed bariatric surgery procedure in the US and worldwide, it is associated with significant postoperative nausea and vomiting (PONV), which can lead to patient readmission for rehydration and symptom control. Enhanced recovery after surgery (ERAS) is an approach that aligns the practice of anesthesia with the care given by the surgical team before, during, and after surgery. A number of prospective series, retrospective analyses and one randomized clinical trial of ERAS use in bariatric patients support the idea that ERAS in this population is feasible, effective and safe and that it is associated with shorter lengths of stay, fewer readmissions and decreased costs. In this protocol, the investigators will conduct a prospective, randomized control study using a structured and integrative perioperative plan (ERAS; n = 64) vs. current standard of care (SOC; n = 64) for patients undergoing LSG at Hartford Hospital. The investigators are guided by the idea that an enhanced recovery protocol can potentially serve to enhance the early patient experience and set the stage for a more rapid transition out of the recovery phase and into the weight loss phase of the patient's care. The investigators will incorporate a postoperative multidrug strategy targeting multiple receptors to decrease PONV and pain, similar to ERAS Society recommendations for bariatric patients.

Specific Aims and Hypotheses The central hypothesis is that the introduction of an ERAS pathway in patients undergoing LSG is feasible and will lead to better clinical outcomes.

Aim 1. To evaluate the effect that introducing an ERAS pathway will have on the use of narcotic medication for the management of postoperative pain, PONV, readiness for discharge, and overall length of stay in patients undergoing LSG.

Aim 2. To evaluate the safety of the ERAS protocol by measuring inpatient and 30-day adverse events, emergency department (ED) visits, outpatient hydration, readmission rates and delirium.

Participants will be recruited through fliers posted at Surgical Weight Loss Center locations (Glastonbury, Enfield, Hartford, Farmington, Manchester and South Windsor).

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT03520803
Study type Interventional
Source Hartford Hospital
Status Recruiting
Phase N/A
Start date February 26, 2018
Completion date January 2019

See also
  Status Clinical Trial Phase
Recruiting NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT03714646 - Beta Glucan and Acetate Production N/A
Recruiting NCT03255005 - Endomina Controlled Study N/A
Enrolling by invitation NCT03063606 - Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment Phase 2/Phase 3
Completed NCT03317587 - Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE) N/A
Terminated NCT03299881 - Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss N/A
Active, not recruiting NCT02558920 - Meta-analyses of Food Sources of Fructose-Containing Sugars and Obesity
Active, not recruiting NCT03610958 - Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss. N/A
Completed NCT02235961 - Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects Phase 1
Completed NCT03195712 - Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers N/A
Completed NCT00341406 - Fat Cell Size in Insulin Resistance
Not yet recruiting NCT03470272 - Effects of Red Light LED Therapy on Body Contouring N/A
Recruiting NCT03627104 - Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity N/A
Recruiting NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Active, not recruiting NCT02918279 - Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity Phase 3
Completed NCT00494767 - Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs Phase 1