Phase 4
Completed N=83
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
Post-operative Nausea and Vomiting · Laparoscopic Sleeve Gastrectomy
Source: ClinicalTrials.gov NCT03435003 ↗
Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Number of Participants With PONV-related Delay of Hospital Discharge — 0; 4 Participants
◆ Published Evidence
Emerging
2citations · ~0 / year
The Relationship Between Postoperative Nausea and Vomiting and Early Self-Rated Quality of Life Following Laparoscopic Sleeve Gastrectomy.
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.
Linked Publications
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The Relationship Between Postoperative Nausea and Vomiting and Early Self-Rated Quality of Life Following Laparoscopic Sleeve Gastrectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With PONV-related Delay of Hospital Discharge |
0; 4 | — |
| SECONDARY Severity of PONV Measured Using a 10-point Verbal Rating Scale. |
0.12; 0.10; 2.29; 3.68; 1.46; 2.76 | — |
| SECONDARY Severity of PONV Measured Using the Rhodes Index |
0.08; 0.19; 1.79; 6.17; 0.69; 5.26 | — |
| SECONDARY Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey |
120.59; 109.29; 137.53; 130.64 | — |
| SECONDARY GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey |
108.34; 107.52; 100.71; 98.03 | — |
| SECONDARY Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument |
29; 29; 7; 8; 3; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients (18 years and older) undergoing LSG
Exclusion Criteria
- Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents)
- Inability to provide informed consent
- History of chronic nausea and emesis requiring medication
- Poorly controlled diabetes (HgA1c>9 mg/dl),
- History of previous bariatric or gastro-esophageal surgery
Data sourced from ClinicalTrials.gov (NCT03435003) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.