Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery
Primary Purpose
Bariatric Surgery Candidate, Postoperative Nausea and Vomiting, Morbid Obesity
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bariatric Full Liquid Diet
Sponsored by
About this trial
This is an interventional prevention trial for Bariatric Surgery Candidate focused on measuring Bariatric Surgery, Sleeve Gastrectomy, Postoperative Diet, Postoperative Nausea and Vomiting
Eligibility Criteria
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
Sites / Locations
- Thomas Jefferson University HospitalRecruiting
- Jefferson Methodist HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Standard bariatric clear liquid diet to be started 4 hours after surgery
Bariatric full liquid diet (clear liquid diet + protein shakes) to be started 4 hours after surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Length of Stay
Time from end of surgery to discharge from hospital
Severity of Postoperative Nausea and Vomiting
Patient reported severity based on surveys
Patient Self-Reported Quality of Recovery
Patient reported quality of recovery based on survey
Hospital Antiemetic Usage
Total amount and type of antiemetic medication received while in the hospital
Cost of Hospital Stay
Total cost of hospital stay after surgery (including initial admission and any readmissions, ED visits, if applicable)
Weight Loss
Percent excess weight loss (EWL) and total weight loss (TWL) 1 week and 1 month after surgery
30-Day Events
Complications, ED Visits, Readmissions
Full Information
NCT ID
NCT04644445
First Posted
November 2, 2020
Last Updated
December 7, 2020
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT04644445
Brief Title
Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery
Official Title
Impact of High-Protein Bariatric Diet on the Prevention of Postoperative Nausea and Vomiting
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Postoperative Nausea and Vomiting, Morbid Obesity
Keywords
Bariatric Surgery, Sleeve Gastrectomy, Postoperative Diet, Postoperative Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard bariatric clear liquid diet to be started 4 hours after surgery
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Bariatric full liquid diet (clear liquid diet + protein shakes) to be started 4 hours after surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
Bariatric Full Liquid Diet
Intervention Description
Patient's will receive a Bariatric Full Liquid Diet (standard bariatric clear liquid diet + protein shakes) to be started 4 hours after surgery
Primary Outcome Measure Information:
Title
Postoperative nausea and vomiting related delay in hospital discharge
Description
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.
Time Frame
through hospital discharge, an average of two days after surgery
Secondary Outcome Measure Information:
Title
Length of Stay
Description
Time from end of surgery to discharge from hospital
Time Frame
through hospital discharge, an average of two days after surgery
Title
Severity of Postoperative Nausea and Vomiting
Description
Patient reported severity based on surveys
Time Frame
Baseline until 1 month after surgery
Title
Patient Self-Reported Quality of Recovery
Description
Patient reported quality of recovery based on survey
Time Frame
Baseline until 1 month after surgery
Title
Hospital Antiemetic Usage
Description
Total amount and type of antiemetic medication received while in the hospital
Time Frame
through hospital discharge, an average of two days after surgery
Title
Cost of Hospital Stay
Description
Total cost of hospital stay after surgery (including initial admission and any readmissions, ED visits, if applicable)
Time Frame
Up to 30 days after surgery
Title
Weight Loss
Description
Percent excess weight loss (EWL) and total weight loss (TWL) 1 week and 1 month after surgery
Time Frame
Up to 30 days after surgery
Title
30-Day Events
Description
Complications, ED Visits, Readmissions
Time Frame
Up to 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Talar Tatarian, MD
Phone
215-955-0020
Email
talar.tatarian@jefferson.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talar Tatarian, MD
Organizational Affiliation
Jefferson Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talar Tatarian, MD
Email
talar.tatarian@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Talar Tatarian, MD
Facility Name
Jefferson Methodist Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talar Tatarian, MD
Email
talar.tatarian@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Talar Tatarian, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery
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