Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Morbid Obesity; Bariatric Surgery Candidate; Postoperative Nausea and Vomiting
• Intervention / Treatment: Dietary supplement: Bariatric Full Liquid Diet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Talar Tatarian, MD; Email: talar.tatarian@jefferson.edu
      • Principal Investigator: Talar Tatarian, MD
    • Philadelphia, Pennsylvania, United States, 19148
      • Recruiting
      • Jefferson Methodist Hospital
      • Contact: Talar Tatarian, MD; Email: talar.tatarian@jefferson.edu
      • Principal Investigator: Talar Tatarian, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard bariatric clear liquid diet to be started 4 hours after surgery
Experimental: Intervention; Bariatric full liquid diet (clear liquid diet + protein shakes) to be started 4 hours after surgery	Dietary supplement: Bariatric 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Talar Tatarian, MD, Jefferson Health

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative Nausea and Vomiting; Bariatric Surgery; Sleeve Gastrectomy; Postoperative Diet
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Nausea; Vomiting; Obesity, Morbid; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 20D.841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No