Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery

Not Applicable

• Conditions: Bariatric Surgery Candidate; Postoperative Nausea and Vomiting; Morbid Obesity
• Interventions: Dietary Supplement: Bariatric Full Liquid Diet

• Registration Number: NCT04644445
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study First Submitted: 2020-11-02
• Study Start: 2020-11-03
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-25
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-09
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention	Bariatric Full Liquid Diet	Bariatric full liquid diet (clear liquid diet + protein shakes) to be started 4 hours after surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Patient Self-Reported Quality of Recovery	Baseline until 1 month after surgery	Patient reported quality of recovery based on survey
Length of Stay	through hospital discharge, an average of two days after surgery	Time from end of surgery to discharge from hospital
Severity of Postoperative Nausea and Vomiting	Baseline until 1 month after surgery	Patient reported severity based on surveys
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)
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
30-Day Events	Up to 30 days after surgery	Complications, ED Visits, Readmissions
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

Trial Locations

Locations (2)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Jefferson Methodist Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States