Enhanced Recovery After Surgery in Laparoscopic Sleeve Gastrectomy
Status: | Recruiting |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 5/17/2018 |
Start Date: | February 26, 2018 |
End Date: | January 2019 |
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).
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).
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
We found this trial at
1
site
80 Seymour St
Hartford, Connecticut 6102
Hartford, Connecticut 6102
(860) 545-5000
Principal Investigator: Pavlos K Papasavas, MD
Phone: 860-246-2071
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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