Clinical trial NCT03435003: Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
Official title: Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Nausea and Vomiting
Laparoscopic Sleeve Gastrectomy
Keywords: Bariatric Procedure
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: To test this hypothesis, participants undergoing sleeve gastrectomy will be randomized to two groups: control vs Nausea specific-intervention group. All subjects will be assessed with a nausea specific questionnaire at 1, 4, 12, 24 hours and 3 weeks after surgery. Patient satisfaction with recovery will be assessed using specialized questionnaires at baseline, 24 hrs. and 3 weeks following surgery. Serial assessments of nausea, vomiting, quality of life and quality of recovery, will allow the investigators to identify an effect on incidence and severity of Post-operative Nausea and Vomiting. Importantly, the investigators will evaluate for an impact in patient-reported measures of quality of life.

The total sample size is 83. This study will provide valuable insight on the epidemiology of post-operative nausea and vomiting after hospital discharge following Sleeve gastrectomy, which is currently poorly characterized. By allowing the investigators to assess the overall incidence of nausea and vomiting at different time points, this study will afford the opportunity to identify a time period of high incidence and further adjust our prevention efforts accordingly in future studies.

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

Primary outcomes:
measure: Number of Participants With PONV-related Delay of Hospital Discharge
timeFrame: up to 1 week post-operation (up to 2 weeks from baseline)
Secondary outcomes:
measure: Severity of PONV Measured Using a 10-point Verbal Rating Scale.
timeFrame: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
measure: Severity of PONV Measured Using the Rhodes Index
timeFrame: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
measure: Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey
timeFrame: 24 hours and 3 weeks
measure: GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey
timeFrame: Baseline, 24 hours and 3 weeks
measure: Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
timeFrame: Baseline, 24 hours and 3 weeks
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook University
name: Konstantinos Spaniolas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naeem Z, Nie L, Drakos P, Yang J, Gan TJ, Pryor AD, Spaniolas K. The Relationship Between Postoperative Nausea and Vomiting and Early Self-Rated Quality of Life Following Laparoscopic Sleeve Gastrectomy. J Gastrointest Surg. 2021 Aug;25(8):2107-2109. doi: 10.1007/s11605-021-04923-4. Epub 2021 Feb 2. No abstract available.