Bariatric Surgery Candidate, Morbid Obesity, Postoperative Nausea and Vomiting
Conditions
Keywords
Bariatric Surgery, Sleeve Gastrectomy, Postoperative Diet, Postoperative Nausea and Vomiting
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.
Interventions
DIETARY_SUPPLEMENTBariatric Full Liquid Diet
Patient's will receive a Bariatric Full Liquid Diet (standard bariatric clear liquid diet + protein shakes) to be started 4 hours after surgery
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea and vomiting related delay in hospital discharge | through hospital discharge, an average of two days after surgery | Inability to be discharged from the hospital on postoperative day 1 due to postoperative nausea and vomiting. This will be measured by inability to maintain oral intake of 4-6 ounces an hour due to feeling of nausea or vomiting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Postoperative Nausea and Vomiting | Baseline until 1 month after surgery | Patient reported severity based on surveys |
| Patient Self-Reported Quality of Recovery | Baseline until 1 month after surgery | Patient reported quality of recovery based on survey |
| Hospital Antiemetic Usage | through hospital discharge, an average of two days after surgery | Total amount and type of antiemetic medication received while in the hospital |
| Length of Stay | through hospital discharge, an average of two days after surgery | Time from end of surgery to discharge from hospital |
| Weight Loss | Up to 30 days after surgery | Percent excess weight loss (EWL) and total weight loss (TWL) 1 week and 1 month after surgery |
| 30-Day Events | Up to 30 days after surgery | Complications, ED Visits, Readmissions |
| Cost of Hospital Stay | Up to 30 days after surgery | Total cost of hospital stay after surgery (including initial admission and any readmissions, ED visits, if applicable) |
Countries
United States
Contacts
Primary ContactTalar Tatarian, MD
Outcome results
None listed