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

Primary Purpose

Ileus Postoperative, Postoperative Nausea and Vomiting

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gastric point of care ultrasound
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ileus Postoperative focused on measuring gastric ultrasound, delayed bowel function, postoperative ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Thomas Jefferson University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Utility of G-POCUS as a clinical decision-making tool - diet advancement
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.

Secondary Outcome Measures

Utility of G-POCUS as a clinical decision-making tool - quality of care metrics
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.

Full Information

First Posted
March 7, 2023
Last Updated
April 6, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT05796063
Brief Title
Postoperative Gastric Point of Care Ultrasound (G-POCUS) in Abdominal Surgery
Official Title
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?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (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
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus Postoperative, Postoperative Nausea and Vomiting
Keywords
gastric ultrasound, delayed bowel function, postoperative ileus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
gastric point of care ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Utility of G-POCUS as a clinical decision-making tool - diet advancement
Description
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.
Time Frame
post-operative day 1 until day of discharge from the hospital for patients in the intervention group
Secondary Outcome Measure Information:
Title
Utility of G-POCUS as a clinical decision-making tool - quality of care metrics
Description
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.
Time Frame
post-operative day 1 until day of discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Phillips, MD
Phone
215-955-5869
Email
benjamin.phillips@jefferson.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Micaela L Collins, MD
Email
micaela.collins@jefferson.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Phillips, MD
Organizational Affiliation
Thomas Jefferson University
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
Benjamin Phillips, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Postoperative Gastric Point of Care Ultrasound (G-POCUS) in Abdominal Surgery

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