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NCT03435003 · ClinicalTrials.gov registry record · Phase 4
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
A Phase 4 study, sponsored by Stony Brook University.
- Completed
- Registry status
- Phase 4
- Development phase
- 83
- Enrollment target
NCT03435003: Completed Phase 4 study, sponsored by Stony Brook University.
NCT03435003 is a Phase 4 study that has completed, run by Stony Brook University. The registered enrollment target is 83 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03435003, a Phase 4 study, has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 83 participants
- Enrollment target
Study Summary
Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and aims to assess the effect of a post-operative nausea and vomiting-specific intervention. The investigators hypothesize that the intervention group will experience a reduction of nausea-related prolonged hospital stay and significantly improve patient-reported quality of recovery from surgery and quality of life.
Primary Outcome
The primary outcome would be incidence of PONV-related delay of hospital discharge following laparoscopic gastrectomy. Based on the current clinical pathway, patients are expected to be discharged on postoperative day 1 (day after surgery). A delay in discharge due to PONV will be the primary outcome.
Interventions
- DRUG Dexamethasone
- DRUG Ondansetron
- DRUG Aprepitant 80 mg Oral Capsule
- DRUG scopolamine transdermal
- PROCEDURE Total intravenous anesthesia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2017-08-28 |
| Est. Completion | 2019-04-01 |
| Phase | Phase 4 |
What the finished NCT03435003 record still lists
NCT03435003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT03435003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03435003 about?
NCT03435003 is a clinical study titled "Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy". Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and aims to assess the eff...
What is the current status of trial NCT03435003?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 83 participants. The study started on 2017-08-28. Estimated completion is 2019-04-01.
What interventions are being tested in trial NCT03435003?
The interventions under investigation include: Dexamethasone (DRUG), Ondansetron (DRUG), Aprepitant 80 mg Oral Capsule (DRUG), scopolamine transdermal (DRUG), Total intravenous anesthesia (PROCEDURE).
Who is sponsoring clinical trial NCT03435003?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03435003's enrollment target sits among peer trials
83 937th of 2000 higher than 1,062 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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