Clinical trial NCT04644445: Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery
Official title: Impact of High-Protein Bariatric Diet on the Prevention of Postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery Candidate
Postoperative Nausea and Vomiting
Morbid Obesity
Keywords: Bariatric Surgery
Sleeve Gastrectomy
Postoperative Diet
Postoperative Nausea and Vomiting
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Postoperative nausea and vomiting are common occurrences following bariatric surgery, occurring in up to 80% of patients and contributing to increased healthcare utilization and delays in discharge. This study aims to evaluate the impact of a high-protein liquid diet on postoperative nausea, vomiting, and length of stay after laparoscopic or robotic sleeve gastrectomy.

Detailed description: Patients with obesity or morbid obesity who are scheduled to undergoing robotic or laparoscopic sleeve gastrectomy will be screened at their preoperative visit. If they meet inclusion/exclusion criteria, they will be invited to participate in the study and written informed consent will be obtained. If the patient consents to participation, they will be randomized to either the control arm or intervention arm. All patients will undergo sleeve gastrectomy in a standard fashion, either laparoscopically or robotically, as discussed with their bariatric surgeon. Post-operative diet will be initiated 4 hours after surgery. The specific diet received will depend on which arm the patient is randomized into. Post-operative assessments will be completed at various time points for all patients. These include a Verbal Rating Scale of Nausea and Vomiting, Rhodes Index Survey, and Quality of Recover-15 Survey. All patients will track their oral intake on a spreadsheet which will be provided. Additional demographic and clinical data will be collected from the Electronic Medical Record. After hospital discharge, patients will follow up in the clinic one week and one month after surgery, per routine. After the one-month visit, the patient's study participation will be considered complete.

Eligibility criteria: Inclusion Criteria:

* Adult patient undergoing robotic or laparoscopic sleeve gastrectomy
* Patient able to provide written informed consent
* Patient able to understand and comply with study guidelines

Exclusion Criteria:

* Inability to provide consent
* Previous history of bariatric or gastroesophageal surgery
* Chronic nausea/vomiting
* Hemoglobin A1C 9 or higher
* Therapeutic anticoagulation
* Celiac disease or gluten sensitivity/intolerance/allergy

Primary outcomes:
measure: Postoperative nausea and vomiting related delay in hospital discharge
timeFrame: through hospital discharge, an average of two days after surgery
Secondary outcomes:
measure: Length of Stay
timeFrame: through hospital discharge, an average of two days after surgery
measure: Severity of Postoperative Nausea and Vomiting
timeFrame: Baseline until 1 month after surgery
measure: Patient Self-Reported Quality of Recovery
timeFrame: Baseline until 1 month after surgery
measure: Hospital Antiemetic Usage
timeFrame: through hospital discharge, an average of two days after surgery
measure: Cost of Hospital Stay
timeFrame: Up to 30 days after surgery
measure: Weight Loss
timeFrame: Up to 30 days after surgery
measure: 30-Day Events
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Methodist Hospital
state: Pennsylvania
Study officials:
affiliation: Jefferson Health
name: Talar Tatarian, MD
role: PRINCIPAL_INVESTIGATOR
References: