Assessing Gastric Motility and Distention in Postoperative Gastrointestinal Surgery Using Bedside Gastric Ultrasound: Predicting Risk of Aspiration Pneumonia, Ileus, Return of Bowel Function

June 2, 2022 updated by: Eric Schwenk
Point-of-care gastric ultrasound will be used to measure stomach contents postoperative in patients who underwent colorectal surgery. Stomach volume and status (empty or full) will be compared retrospectively to the standard clinical criteria for diet advancement to determine if stomach volume via ultrasound is associated with successful diet advancement, nausea/vomiting, nasogastric tube replacement, length of stay, and other clinical outcomes. Clinicians performing clinical care will be blinded to the ultrasound exam results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patient population: Patients undergoing colorectal surgery will be enrolled prospectively (both cancer and non-cancer patients).

Inclusion Criteria:

  • Patients aged > 18 years of age
  • Patients undergoing colorectal surgery (both cancer and non-cancer)

Exclusion Criteria:

  • Patients < 18 years of age

  • Patients with previous gastric surgery

    • Patients with inadequate or difficult baseline gastric ultrasound images
    • Any other patient deemed a poor study candidate by the treating physicians

Research Design/Protocol: We will perform postoperative point-of-care ultrasound examinations in colorectal surgery patients and will record gastric volumes at set time points, including preoperative and the morning of postoperative day 1. The surgical team, who will be blinded to the results of the ultrasound exam, will make decisions to advance diet, remove nasogastric tube, and begin oral medications based on standard clinical criteria. At the completion of the study we will determine if there is any association between gastric volume on ultrasound and patient complications, such as nausea/vomiting, replacement of nasogastric tube, aspiration of gastric contents, inability to tolerate solid diet, prolonged admission/length of stay, and other clinical outcomes.

Outcomes: Our exploratory outcome measures will be tolerance of diet, replacement of NG tube, nausea/vomiting, time to flatus, aspiration pneumonia/pneumonitis, and length of stay.

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients scheduled for colorectal surgery

Description

Inclusion Criteria:

  • Patients aged > 18 years of age
  • Patients undergoing colorectal surgery (both cancer and non-cancer)

Exclusion Criteria:

  • Patients < 18 years of age

  • Patients with previous gastric surgery

    • Patients with difficult or poor ultrasound images at baseline
    • Any patient deemed a poor candidate by the treating physicians

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients assessed with postoperative bedside gastric ultrasound
This patient population will include postoperative patients who received a gastrointestinal surgery and are being assessed with the bedside gastric ultrasound.
Diagnostic test: Bedside gastric ultrasound
Bedside ultrasound exam of the stomach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance of diet advancement
Time Frame: 0 - 14 days
Includes replacement of NGT, downgrading diet
0 - 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emesis
Time Frame: 0 - 14 days
0 - 14 days
Time to first flatus
Time Frame: 0 - 14 days
0 - 14 days
Aspiration pneumonitis
Time Frame: 0 - 14 days
Clinical or radiographic evidence of aspiration
0 - 14 days
Time to first bowel movement
Time Frame: 0 - 14 days
0 - 14 days

Other Outcome Measures

Outcome Measure
Time Frame
Nausea
Time Frame: 0 - 14 days
0 - 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eric Schwenk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2021

Primary Completion (Actual)

June 8, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 2, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20D.1009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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