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OpenTrials
Completed

NCT Number: NCT04747691

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bedside gastric ultrasound

Diagnostic Test

Bedside ultrasound exam of the stomach

Primary outcomes

  1. Tolerance of diet advancement

    Time frame: 0 - 14 days

    Includes replacement of NGT, downgrading diet

Secondary outcomes

  1. Emesis

    Time frame: 0 - 14 days

  2. Time to first flatus

    Time frame: 0 - 14 days

  3. Aspiration pneumonitis

    Time frame: 0 - 14 days

    Clinical or radiographic evidence of aspiration

  4. Time to first bowel movement

    Time frame: 0 - 14 days

Other outcomes

  1. Nausea

    Time frame: 0 - 14 days

Sponsors and collaborators

Lead sponsor

Eric Schwenk

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2021
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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