Clinical trial NCT03520803: Enhanced Recovery After Surgery in Laparoscopic Sleeve Gastrectomy
Official title: A Prospective Randomized Study of an Enhanced Recovery After Surgery Pathway in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
bariatric surgery
enhanced recovery after surgery
sleeve gastrectomy
gastric bypass
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).


Eligibility criteria: Inclusion Criteria:

• Patients scheduled to have laparoscopic sleeve gastrectomy at our surgical weight loss center

Exclusion Criteria:

* Participants whose primary language is not English;
* Patients who are wheel chair-bound and those who are on dialysis with end stage renal disease;
* Patients who have known allergic reactions to any of the ERAS protocol medications, which upon review by the clinical team are deemed clinically significant;
* Patients with a history of cardiac events or a prolonged QTc interval on preoperative EKG which could in the opinion of the investigators increase their risk for prolonged QTc interval when certain ERAS medications are given in combination;
* Patients who have chronic kidney disease (contraindication to use NSAIDs) or are currently taking narcotic pain medications

Primary outcomes:
measure: Rate of post-operative administration of narcotics or rescue anti-nausea medications
timeFrame: 1 week
measure: Readiness for discharge
timeFrame: 1 day
measure: Hospital length of stay
timeFrame: 1 week
Secondary outcomes:
measure: Adverse events
timeFrame: Measured continuously throughout hospital stay up to 30 days post discharge
measure: Delirium
timeFrame: 1 week
Other outcomes:
measure: BMI
timeFrame: Baseline
measure: Pain
timeFrame: 1 week
measure: Post-operative nausea and vomiting
timeFrame: 1 week
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Pavlos K Papasavas, MD
role: PRINCIPAL_INVESTIGATOR
References: