Recruiting

G-POCUS

Sponsor:

Thomas Jefferson University

Code:

NCT05796063

Conditions

Ileus Postoperative

Postoperative Nausea and Vomiting

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

gastric point of care ultrasound

Study Details

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.

Conditions

Ileus Postoperative

Postoperative Nausea and Vomiting

Study ID

NCT05796063

Start date

Apr 1, 2023

Status verified date

Apr, 2023

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Apr 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Benjamin Phillips, MD

215-955-5869benjamin.phillips@jefferson.edu

Micaela L Collins, MD

micaela.collins@jefferson.edu

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

More Information

Sponsor

Thomas Jefferson University

Last update posted

Apr 7, 2023

Last verified

Apr, 2023

Keywords

  • gastric ultrasound
  • delayed bowel function
  • postoperative ileus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2023-04-07.