Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of High-Protein Bariatric Diet on the Prevention of Postoperative Nausea and Vomiting

Conditions
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Bariatric Surgery Candidate, Postoperative Nausea and Vomiting, Morbid Obesity

Intervention / Treatment
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* Dietary Supplement: Bariatric Full Liquid Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard bariatric clear liquid diet to be started 4 hours after surgery | |
| Experimental: Intervention<br>Bariatric full liquid diet (clear liquid diet + protein shakes) to be started 4 hours after surgery | Dietary Supplement: Bariatric Full Liquid Diet<br>* Patient's will receive a Bariatric Full Liquid Diet (standard bariatric clear liquid diet + protein shakes) to be started 4 hours after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting related delay in hospital discharge | 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. | through hospital discharge, an average of two days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Time from end of surgery to discharge from hospital | through hospital discharge, an average of two days after surgery | 
| Severity of Postoperative Nausea and Vomiting | Patient reported severity based on surveys | Baseline until 1 month after surgery | 
| Patient Self-Reported Quality of Recovery | Patient reported quality of recovery based on survey | Baseline until 1 month after surgery | 
| Hospital Antiemetic Usage | Total amount and type of antiemetic medication received while in the hospital | through hospital discharge, an average of two days after surgery | 
| Cost of Hospital Stay | Total cost of hospital stay after surgery (including initial admission and any readmissions, ED visits, if applicable) | Up to 30 days after surgery | 
| Weight Loss | Percent excess weight loss (EWL) and total weight loss (TWL) 1 week and 1 month after surgery | Up to 30 days after surgery | 
| 30-Day Events | Complications, ED Visits, Readmissions | Up to 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric Surgery, Sleeve Gastrectomy, Postoperative Diet, Postoperative Nausea and Vomiting