Clinical trial NCT04747691: Assessing Gastric Motility and Distention in Postoperative Gastrointestinal Surgery Using Bedside Gastric Ultrasound: Predicting Risk of Aspiration Pneumonia, Ileus, Return of Bowel Function
Official title: Assessing Gastric Motility and Distention in Postoperative Gastrointestinal Surgery Using Bedside Gastric Ultrasound: Predicting Risk of Aspiration Pneumonia, Ileus, Return of Bowel Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Ileus
Postoperative Nausea
Postoperative Complications
Postoperative Nausea and Vomiting
Postoperative Vomiting
Aspiration Vomitus
Keywords: Postoperative Complications
Postoperative Ileus
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients scheduled for colorectal surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tolerance of diet advancement
timeFrame: 0 - 14 days
Secondary outcomes:
measure: Emesis
timeFrame: 0 - 14 days
measure: Time to first flatus
timeFrame: 0 - 14 days
measure: Aspiration pneumonitis
timeFrame: 0 - 14 days
measure: Time to first bowel movement
timeFrame: 0 - 14 days
Other outcomes:
measure: Nausea
timeFrame: 0 - 14 days
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References:
citation: Haskins SC, Kruisselbrink R, Boublik J, Wu CL, Perlas A. Gastric Ultrasound for the Regional Anesthesiologist and Pain Specialist. Reg Anesth Pain Med. 2018 Oct;43(7):689-698. doi: 10.1097/AAP.0000000000000846.
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citation: Wolthuis AM, Bislenghi G, Fieuws S, de Buck van Overstraeten A, Boeckxstaens G, D'Hoore A. Incidence of prolonged postoperative ileus after colorectal surgery: a systematic review and meta-analysis. Colorectal Dis. 2016 Jan;18(1):O1-9. doi: 10.1111/codi.13210.
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citation: Vather R, O'Grady G, Bissett IP, Dinning PG. Postoperative ileus: mechanisms and future directions for research. Clin Exp Pharmacol Physiol. 2014 May;41(5):358-70. doi: 10.1111/1440-1681.12220.