Clinical trial NCT05796063: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ileus Postoperative
Postoperative Nausea and Vomiting
Keywords: gastric ultrasound
delayed bowel function
postoperative ileus
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Utility of G-POCUS as a clinical decision-making tool - diet advancement
timeFrame: post-operative day 1 until day of discharge from the hospital for patients in the intervention group
Secondary outcomes:
measure: Utility of G-POCUS as a clinical decision-making tool - quality of care metrics
timeFrame: post-operative day 1 until day of discharge
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Benjamin Phillips, MD
role: PRINCIPAL_INVESTIGATOR
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