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Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery

NCT ID: NCT04644445

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-03

Study Completion Date

2021-10-31

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery Candidate Postoperative Nausea and Vomiting Morbid Obesity

Keywords

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Bariatric Surgery Sleeve Gastrectomy Postoperative Diet Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type EXPERIMENTAL

Bariatric Full Liquid Diet

Intervention Type DIETARY_SUPPLEMENT

Patient's will receive a Bariatric Full Liquid Diet (standard bariatric clear liquid diet + protein shakes) to be started 4 hours after surgery

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Talar Tatarian, MD

Role: PRINCIPAL_INVESTIGATOR

Jefferson Health

Locations

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Jefferson Methodist Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Talar Tatarian, MD

Role: CONTACT

Phone: 215-955-0020

Email: [email protected]

Facility Contacts

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Talar Tatarian, MD

Role: primary

Talar Tatarian, MD

Role: primary

Other Identifiers

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20D.841

Identifier Type: -

Identifier Source: org_study_id