Hartford Hospital
Hartford, Connecticut, 06102, United States
NCT Number: NCT03520803
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).
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Hartford, Connecticut, 06102, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Experimental enhanced recovery protocol for pre-surgery and post surgery
Other names: ERAS
Time frame: 1 week
Including dilaudid, zofran, haldol, phenergan, ketorolac, remeron
Time frame: 1 day
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.
Time frame: 1 week
Total length of stay in the hospital in days
Time frame: Measured continuously throughout hospital stay up to 30 days post discharge
Total number of inpatient and 30 - day adverse events
Time frame: 1 week
Delirium as measured using the Confusion Assessment Method
Time frame: Baseline
Body mass index
Time frame: 1 week
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
Time frame: 1 week
Measured using the Postoperative Nausea and Vomiting Impact Scale. Scores range from 0 - 6, >/= 5 indicates clinically important post-operative nausea/vomiting
Hartford Hospital
Other
A Prospective Randomized Study of an Enhanced Recovery After Surgery Pathway in Patients Undergoing Laparoscopic Sleeve Gastrectomy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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