Postoperative Gastric Point of Care Ultrasound (G-POCUS) in Abdominal Surgery

April 6, 2023 updated by: Thomas Jefferson University

Postoperative Gastric Point of Care Ultrasound (G-POCUS) in Abdominal Surgery: Can G-POCUS Guidance in Clinical Management of Gastrointestinal Recovery Lead to Better Outcomes?

The purpose of this research is to determine if gastric point of care ultrasound (G-POCUS) can be used to help clinicians determine when to feed patients or when to insert or remove nasogastric tubes for patients recovering from colorectal or abdominal surgery.

Patients enrolled in the intervention group will have G-POCUS exams performed after surgery. The results of the exams will be used to make clinical decisions.

Researchers will compare these patients to patients receiving the usual care in the hospital after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Delayed bowel function (DBF) and postoperative ileus (POI), or disruption of the normal forward peristaltic bowel activity after abdominal surgery are common complications in general surgery patients that can lead to nausea, emesis, bowel perforation, or aspiration pneumonitis. DBF and POI increase length of stay, morbidity, and mortality in general surgery patients. It is extremely difficult to predict who will develop DBF and POI. Further, diagnosing patients with postoperative DBF or POI is almost entirely based upon clinical acumen, history, and physical exam. To date no imaging or laboratory studies are specifically recommended to diagnose these complications.

Gastric Point of Care Ultrasound (G-POCUS) is a simple and reliable imaging modality that can be performed at the bedside and does not involve ionizing radiation. In the pilot study, it was hypothesized that G-POCUS volume (ie: whether a patient's stomach appears full or empty) would correlate with measures of delayed bowel functioning based on identification of full versus empty stomach postoperatively following colorectal surgery. We found that patients with full stomachs had a higher incidence of DBF, length of stay, emesis, and need for nasogastric tube (NGT) placement.

This will be a randomized single-blinded study of handheld G-POCUS in which the study population will be inpatients hospitalized after abdominal/colorectal surgery. Patients will be randomized to an unblinded intervention arm or an unblinded standard of care arm. On postoperative day 1 (POD1), patients will be asked if they are having any GI symptoms. These are defined as presence of nausea, emesis, belching, and/or hiccups. In the intervention arm, clinicians will use the results of G-POCUS and presence/absence of GI symptoms to inform decision making according to one of two standardized algorithms. In the control arm, presence of GI symptoms will be assessed, and once of two standardized algorithms which are representative of the current standard of care for postoperative diet management. Data from both groups will be used to determine if the G-POCUS studies' results can predict the incidence of primary or secondary outcomes (control) or if intervening on results of G-POCUS can decrease the incidence of undesirable outcomes.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
          • Benjamin Phillips, MD

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria:

    • Completed signed and dated informed consent form
    • Willing to comply with all study procedures
    • Male or female, 18 years of age or older
    • Presenting for a schedule elective colorectal/abdominal surgery, either open, robotic, or laparoscopic

Exclusion Criteria:

  • History of gastroparesis or known gastric/intestinal motility disorder
  • History of gastric/bariatric surgery
  • Intubated/sedated postoperatively
  • Presence of open abdominal wounds (including abdominal wound vac)
  • Patients who received a complex abdominal wall reconstruction
  • Class III/IV Wound (Contaminated/Infected/Dirty)
  • Surgery was emergent/urgent/unscheduled
  • NGT placed or present at time of operation
  • Presence of ileostomy/colostomy
  • J-pouch reconstruction patients
  • Currently pregnant patients
  • Patients aged <18 years old

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
On postoperative day one, patients will be asked if they are having any GI symptoms. These are defined as presence of nausea, emesis, belching, and/or hiccups. In the intervention arm, clinicians will use the results of G-POCUS and presence/absence of GI symptoms to inform decision making according to one of two standardized algorithms.
Diagnostic test: gastric point of care ultrasound
Patients will receive a gastric point of care ultrasound to evaluate for delayed gastric emptying. Gastric POCUS studies will be obtained using Kosmos, a handheld portable ultrasound that is FDA approved for clinical use. This product has already been validated for use, and this is not a novel application of the technology.
No Intervention: Control
On postoperative day one, patients will be asked if they are having any GI symptoms. These are defined as presence of nausea, emesis, belching, and/or hiccups. In the control arm, presence of GI symptoms will be assessed, and once of two standardized algorithms which are representative of the current standard of care for postoperative diet management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility of G-POCUS as a clinical decision-making tool - diet advancement
Time Frame: post-operative day 1 until day of discharge from the hospital for patients in the intervention group
Patients enrolled in the intervention arm will have G-POCUS exams performed. A previously validated algorithm will be used to determine if their stomach is full or empty. Based on this result, decisions by the clinical team will be made regarding the patients' diet, need for nasogastric decompression using a standardized algorithm.
post-operative day 1 until day of discharge from the hospital for patients in the intervention group

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility of G-POCUS as a clinical decision-making tool - quality of care metrics
Time Frame: post-operative day 1 until day of discharge
The results from the intervention group will be compared to the control group (which will also proceed according to a standardized algorithm that reflects the current standard of care) to determine if there are differences in length of stay and aspiration pneumonia/pneumonitis between groups.
post-operative day 1 until day of discharge

Collaborators and Investigators

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

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Benjamin Phillips, MD, Thomas Jefferson University

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 (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iRISID-2022-1082

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

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.

Clinical Trials on Postoperative Nausea and Vomiting

Clinical Trials on gastric point of care ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe