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NCT03520803 · ClinicalTrials.gov registry record · NA
Enhanced Recovery After Surgery in Laparoscopic Sleeve Gastrectomy
A NA study, sponsored by Hartford Hospital.
- Completed
- Registry status
- NA
- Development phase
- 132
- Enrollment target
NCT03520803 is a NA study that has completed, run by Hartford Hospital. The registered enrollment target is 132 participants.
The verdict
NCT03520803, a NA study, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 132 participants
- Enrollment target
Study 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)
Interventions
- OTHER Enhanced recovery after surgery protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2019-01-26 |
| Est. Completion | 2020-01-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03520803
The ClinicalTrials.gov registry entry for NCT03520803 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hartford Hospital, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Enhanced recovery after surgery protocol is the first listed.
NCT03520803 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03520803 about?
NCT03520803 is a clinical study titled "Enhanced Recovery After Surgery in 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 reco...
What is the current status of trial NCT03520803?
This trial is currently completed. It is a NA study. The enrollment target is 132 participants. The study started on 2019-01-26. Estimated completion is 2020-01-30.
What interventions are being tested in trial NCT03520803?
The interventions under investigation include: Enhanced recovery after surgery protocol (OTHER).
Who is sponsoring clinical trial NCT03520803?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
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