Enhanced Recovery After Surgery in Laparoscopic Sleeve Gastrectomy

NCT ID: NCT03520803

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-26
• Study Completion Date: 2020-01-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental

ERAS protocol

Group Type: EXPERIMENTAL

Enhanced recovery after surgery protocol

Intervention Type: OTHER

Experimental enhanced recovery protocol for pre-surgery and post surgery

Control

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Enhanced recovery after surgery protocol

Experimental enhanced recovery protocol for pre-surgery and post surgery

Intervention Type: OTHER

Other Intervention Names

ERAS

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pavlos K Papasavas, MD

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Locations

Hartford Hospital

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

HHC-2017-0146

Identifier Type: -

Identifier Source: org_study_id