Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bariatric Surgery Candidate
  • Morbid Obesity
  • Postoperative Nausea and Vomiting
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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. ...

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.

Tracking Information

NCT #
NCT04644445
Collaborators
Not Provided
Investigators
Principal Investigator: Talar Tatarian, MD Jefferson Health