NCT04644445

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

November 3, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

November 2, 2020

Last Update Submit

December 7, 2020

Conditions

Bariatric Surgery CandidatePostoperative Nausea and VomitingMorbid Obesity

Keywords

Bariatric SurgerySleeve GastrectomyPostoperative DietPostoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Length of Stay

    through hospital discharge, an average of two days after surgery

  • Severity of Postoperative Nausea and Vomiting

    Baseline until 1 month after surgery

  • Patient Self-Reported Quality of Recovery

    Baseline until 1 month after surgery

  • Hospital Antiemetic Usage

    through hospital discharge, an average of two days after surgery

  • Cost of Hospital Stay

    Up to 30 days after surgery

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Dietary Supplement: Bariatric Full Liquid Diet

Interventions

Bariatric Full Liquid DietDIETARY_SUPPLEMENT

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient undergoing robotic or laparoscopic sleeve gastrectomy
  • Patient able to provide written informed consent
  • Patient able to understand and comply with study guidelines

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Jefferson Methodist Hospital

Philadelphia, Pennsylvania, 19148, United States

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and VomitingObesity, Morbid

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomitingObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Talar Tatarian, MD

    Jefferson Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Talar Tatarian, MD

CONTACT

215-955-0020talar.tatarian@jefferson.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 25, 2020

Study Start

November 3, 2020

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

December 9, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)