Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04644445
• Other study ID #: 20D.841
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: December 2020
• Source: Thomas Jefferson University
• Contact: Talar Tatarian, MD
• Phone: 215-955-0020
• Email: talar.tatarian[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Jefferson Methodist Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

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