Enhanced Recovery After Surgery in Laparoscopic Sleeve Gastrectomy

A Prospective Randomized Study of an Enhanced Recovery After Surgery Pathway in Patients Undergoing Laparoscopic Sleeve Gastrectomy

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).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Enhanced recovery after surgery protocol

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care
Experimental: Experimental; ERAS protocol	Other: Enhanced recovery after surgery protocol; Experimental enhanced recovery protocol for pre-surgery and post surgery; Other Names: ERAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of post-operative administration of narcotics or rescue anti-nausea medications	Including dilaudid, zofran, haldol, phenergan, ketorolac, remeron	1 week
Readiness for discharge	Readiness for discharge score: Taking 5 factors into account. Scores can range from 0 to 5 with a higher score representing higher readiness for discharge.	1 day
Hospital length of stay	Total length of stay in the hospital in days	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Total number of inpatient and 30 - day adverse events	Measured continuously throughout hospital stay up to 30 days post discharge
Delirium	Delirium as measured using the Confusion Assessment Method	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Body mass index	Baseline
Pain	Measured using the Pain Numeric Rating Scale. Patients are asked to rate their current pain with a low score representing less pain and a high score representing more pain Scores range from 0 - 10, as follows 2= mild pain, does not limit activities; 4= moderate pain, can do most activities with rest; 6= unable to do some activities because of pain; 8= severe pain, unable to do most activities because of pain; 10 = excruciating, unable to do any activities because of pain	1 week
Post-operative nausea and vomiting	Measured using the Postoperative Nausea and Vomiting Impact Scale. Scores range from 0 - 6, >/= 5 indicates clinically important post-operative nausea/vomiting	1 week

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Investigators: Principal Investigator: Pavlos K Papasavas, MD, Hartford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2019
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: obesity; bariatric surgery; sleeve gastrectomy; gastric bypass; enhanced recovery after surgery
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: HHC-2017-0146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No