Enhanced Recovery After Surgery in Laparoscopic Sleeve Gastrectomy

NCT03520803 | Completed

• 1 other identifier: HHC-2017-0146
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity

Keywords

obesity; bariatric surgery; enhanced recovery after surgery; sleeve gastrectomy; gastric bypass

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Adverse events

  Measured continuously throughout hospital stay up to 30 days post discharge

• Delirium

  1 week

Other Outcomes (3)

• BMI

  Baseline

• Pain

  1 week

• Post-operative nausea and vomiting

  1 week

Study Arms (2)

Experimental

EXPERIMENTAL

ERAS protocol

Other: Enhanced recovery after surgery protocol

Control

NO INTERVENTION

Standard of care

Interventions

Enhanced recovery after surgery protocol OTHER

Experimental enhanced recovery protocol for pre-surgery and post surgery

Also known as: ERAS

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pavlos K Papasavas, MD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: May 11, 2018
• Study Start: January 26, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

US (1)