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

Completed

• Conditions: Postoperative Ileus; Postoperative Nausea; Postoperative Complications; Postoperative Nausea and Vomiting; Postoperative Vomiting; Aspiration Vomitus
• Interventions: Diagnostic Test: Bedside gastric ultrasound

• Registration Number: NCT04747691
• Lead Sponsor: Eric Schwenk

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Study Start: 2021-02-12
• Primary Completion: 2021-06-08
• Study Completion: 2021-07-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients assessed with postoperative bedside gastric ultrasound	Bedside gastric ultrasound	This patient population will include postoperative patients who received a gastrointestinal surgery and are being assessed with the bedside gastric ultrasound.

Primary Outcome Measures

Name	Time	Method
Tolerance of diet advancement	0 - 14 days	Includes replacement of NGT, downgrading diet

Secondary Outcome Measures

Name	Time	Method
Emesis	0 - 14 days
Time to first flatus	0 - 14 days
Time to first bowel movement	0 - 14 days
Aspiration pneumonitis	0 - 14 days	Clinical or radiographic evidence of aspiration

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States