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G-POCUS for Post-operative Ileus
N/A
Recruiting
Led By Benjamin Phillips, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative day 1 until day of discharge
Awards & highlights
Study Summary
This trial will test if G-POCUS can help doctors decide when to feed & insert/remove tubes in patients who had colorectal/abdominal surgery.
Who is the study for?
This trial is for adults over 18 who are having scheduled elective colorectal or abdominal surgery. They must be able to follow the study's procedures and sign a consent form. It's not for those with open wounds, emergency surgeries, existing nasogastric tubes, stomach/intestinal issues, past gastric surgery, or pregnant women.Check my eligibility
What is being tested?
The trial tests if using G-POCUS (a type of ultrasound) after surgery can help decide when patients should eat or need nasogastric tubes compared to standard hospital care. One group will receive G-POCUS exams post-surgery; their results guide clinical decisions.See study design
What are the potential side effects?
G-POCUS is generally safe but may cause minor discomfort during the procedure. There are no significant side effects associated with this non-invasive imaging technique.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative day 1 until day of discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative day 1 until day of discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Utility of G-POCUS as a clinical decision-making tool - diet advancement
Secondary outcome measures
Utility of G-POCUS as a clinical decision-making tool - quality of care metrics
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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.
Group II: ControlActive Control1 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 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.
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Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,361 Total Patients Enrolled
2 Trials studying Postoperative Nausea and Vomiting
154 Patients Enrolled for Postoperative Nausea and Vomiting
Benjamin Phillips, MDPrincipal InvestigatorThomas Jefferson University
1 Previous Clinical Trials
224 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a J-pouch reconstruction.My surgery was unplanned and done urgently.I have an open wound on my abdomen.I have an ileostomy or colostomy.I have had weight loss surgery in the past.I was put on a breathing machine and sedated after surgery.I am scheduled for elective surgery on my colon or abdomen.My wound is severely infected or very dirty.I had surgery to rebuild my abdominal wall.I am 18 years old or older.I have a history of slow stomach emptying or other digestive movement issues.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this trial open to volunteers at the present time?
"Per clinicaltrials.gov, this experiment is currently seeking participants with the initial posting on April 1st and most recent update occuring a week later on April 6th."
Answered by AI
What is the scope of the study population for this clinical trial?
"Affirmative. The clinicaltrials.gov website indicates that the trial is actively searching for participants, with a listing posted on April 1st 2023 and last updated 6 days later. A total of 128 patients are needed from one centre to complete the study."
Answered by AI
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