Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery

Last updated: December 7, 2020
Sponsor: Thomas Jefferson University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lactose Intolerance

Colic

Obesity

Treatment

N/A

Clinical Study ID

NCT04644445
20D.841
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 112
Study Start date:
November 03, 2020
Estimated Completion Date:
October 31, 2021

Study 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.

Connect with a study center

  • Jefferson Methodist Hospital

    Philadelphia, Pennsylvania 19148
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

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