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.
Eligible Conditions
- Post-operative Ileus
- Postoperative Nausea and Vomiting
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: post-operative day 1 until day of discharge
Day 1
Utility of G-POCUS as a clinical decision-making tool - quality of care metrics
Day 1
Utility of G-POCUS as a clinical decision-making tool - diet advancement
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
Control
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment
128 Total Participants · 2 Treatment Groups
Primary Treatment: Intervention · No Placebo Group · N/A
Intervention
DiagnosticTest
Experimental Group · 1 Intervention: gastric point of care ultrasound · Intervention Types: DiagnosticTestControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post-operative day 1 until day of discharge
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
416 Previous Clinical Trials
136,686 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
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Asgeirsson, Theodor, Khaled I. El-Badawi, Ali Mahmood, Jeffrey Barletta, Martin Luchtefeld, and Anthony J. Senagore. 2010. “Postoperative Ileus: It Costs More Than You Expect”. Journal of the American College of Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jamcollsurg.2009.09.028.
- Bragg D, El-Sharkawy AM, Psaltis E, Maxwell-Armstrong CA, Lobo DN. Postoperative ileus: Recent developments in pathophysiology and management. Clin Nutr. 2015 Jun;34(3):367-76. doi: 10.1016/j.clnu.2015.01.016. Epub 2015 Jan 31.
- Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17.
- Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
- 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.
- Heinberg EM, Finan MA, Chambers RB, Bazzett LB, Kline RC. Postoperative ileus on a gynecologic oncology service--do abdominal X-rays have a role? Gynecol Oncol. 2003 Jul;90(1):158-62. doi: 10.1016/s0090-8258(03)00247-6.
- Lamm R, Collins M, Bloom J, Joel M, Iosif L, Park D, Reny J, Schultz S, Yeo CJ, Beausang D, Schwenk ES, Costanzo C, Phillips BR. Postoperative Handheld Gastric Point-of-Care Ultrasound and Delayed Bowel Function. J Am Coll Surg. 2023 Jan 5. doi: 10.1097/XCS.0000000000000536. Online ahead of print.
- Lamm R, Bloom J, Collins M, Goldman D, Beausang D, Costanzo C, Schwenk ES, Phillips B. A Role for Gastric Point of Care Ultrasound in Postoperative Delayed Gastrointestinal Functioning. J Surg Res. 2022 Aug;276:92-99. doi: 10.1016/j.jss.2022.02.028. Epub 2022 Mar 24.
- Lamm R, Collins M, Bloom J, Joel M, Iosif L, Park D, Reny J, Schultz S, Phillips B, Schwenk E, Costanzo C. Novice User Learning Curve for Handheld Gastric Point of Care Ultrasound Evaluations to Detect Delayed Return of Postoperative Peristalsis. Am Surg. 2023 Feb 14:31348231156770. doi: 10.1177/00031348231156770. Online ahead of print. No abstract available.
- Mirbagheri N, Dunn G, Naganathan V, Suen M, Gladman MA. Normal Values and Clinical Use of Bedside Sonographic Assessment of Postoperative Gastric Emptying: A Prospective Cohort Study. Dis Colon Rectum. 2016 Aug;59(8):758-65. doi: 10.1097/DCR.0000000000000637.
- Nielsen, Suzanne, Louisa Degenhardt, Bianca Hoban, and Natasa Gisev. 2015. “A Synthesis of Oral Morphine Equivalents (OME) for Opioid Utilisation Studies”. Pharmacoepidemiology and Drug Safety. Wiley. doi:10.1002/pds.3945.
- Scarborough, John E., Jessica Schumacher, K. Craig Kent, Charles P. Heise, and Caprice C. Greenberg. 2017. “Associations of Specific Postoperative Complications with Outcomes After Elective Colon Resection”. JAMA Surgery. American Medical Association (AMA). doi:10.1001/jamasurg.2016.4681.
- Schwenk ES, Grant AE, Torjman MC, McNulty SE, Baratta JL, Viscusi ER. The Efficacy of Peripheral Opioid Antagonists in Opioid-Induced Constipation and Postoperative Ileus: A Systematic Review of the Literature. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):767-777. doi: 10.1097/AAP.0000000000000671.
- Sommer NP, Schneider R, Wehner S, Kalff JC, Vilz TO. State-of-the-art colorectal disease: postoperative ileus. Int J Colorectal Dis. 2021 Sep;36(9):2017-2025. doi: 10.1007/s00384-021-03939-1. Epub 2021 May 11.
- Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.
- Vather R, Trivedi S, Bissett I. Defining postoperative ileus: results of a systematic review and global survey. J Gastrointest Surg. 2013 May;17(5):962-72. doi: 10.1007/s11605-013-2148-y. Epub 2013 Feb 2.
- Wu Z, Boersema GS, Dereci A, Menon AG, Jeekel J, Lange JF. Clinical endpoint, early detection, and differential diagnosis of postoperative ileus: a systematic review of the literature. Eur Surg Res. 2015;54(3-4):127-38. doi: 10.1159/000369529. Epub 2014 Dec 10.
- Zhang X, Zheng W, Chen C, Kang X, Zheng Y, Bao F, Gan S, Zhu S. Goal-directed fluid therapy does not reduce postoperative ileus in gastrointestinal surgery: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Nov;97(45):e13097. doi: 10.1097/MD.0000000000013097.
- Lamm R, Collins M, Bloom J, Joel M, Iosif L, Park D, Reny J, Schultz S, Yeo CJ, Beausang D, Schwenk ES, Costanzo C, Phillips BR. Postoperative Handheld Gastric Point-of-Care Ultrasound and Delayed Bowel Function. J Am Coll Surg. 2023 Apr 1;236(4):554-559. doi: 10.1097/XCS.0000000000000536. Epub 2023 Jan 5.
- 2023. "Postoperative Gastric Point of Care Ultrasound (G-POCUS) in Abdominal Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05796063.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer