Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery

Thomas Jefferson University

Status: Unknown

Conditions: Postoperative Nausea and Vomiting; Bariatric Surgery Candidate; Morbid Obesity

Treatments: Dietary Supplement: Bariatric Full Liquid Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04644445

20D.841

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Control

No Intervention group

Description:

Standard bariatric clear liquid diet to be started 4 hours after surgery

Intervention

Experimental group

Description:

Bariatric full liquid diet (clear liquid diet + protein shakes) to be started 4 hours after surgery

Treatment:

Dietary Supplement: Bariatric Full Liquid Diet