Postoperative Gastric Point of Care Ultrasound (G-POCUS) in Abdominal Surgery

NCT05796063 | Unknown

• 1 other identifier: iRISID-2022-1082
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileus Postoperative; Postoperative Nausea and Vomiting

Keywords

gastric ultrasound; delayed bowel function; postoperative ileus

Outcome Measures

Primary Outcomes (1)

• Utility of G-POCUS as a clinical decision-making tool - diet advancement

  Patients enrolled in the intervention arm will have G-POCUS exams performed. A previously validated algorithm will be used to determine if their stomach is full or empty. Based on this result, decisions by the clinical team will be made regarding the patients' diet, need for nasogastric decompression using a standardized algorithm.

  post-operative day 1 until day of discharge from the hospital for patients in the intervention group

Secondary Outcomes (1)

• Utility of G-POCUS as a clinical decision-making tool - quality of care metrics

  post-operative day 1 until day of discharge

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Diagnostic Test: gastric point of care ultrasound

Control

NO 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.

Interventions

gastric point of care ultrasound DIAGNOSTIC_TEST

Patients will receive a gastric point of care ultrasound to evaluate for delayed gastric emptying. Gastric POCUS studies will be obtained using Kosmos, a handheld portable ultrasound that is FDA approved for clinical use. This product has already been validated for use, and this is not a novel application of the technology.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (18)

• Asgeirsson T, El-Badawi KI, Mahmood A, Barletta J, Luchtefeld M, Senagore AJ. Postoperative ileus: it costs more than you expect. J Am Coll Surg. 2010 Feb;210(2):228-31. doi: 10.1016/j.jamcollsurg.2009.09.028. Epub 2009 Nov 18.

  PMID: 20113944 BACKGROUND

• 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.

  PMID: 25819420 BACKGROUND

• 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.

  PMID: 21242424 BACKGROUND

• 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.

  PMID: 30426190 BACKGROUND

• 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.

  PMID: 30052550 BACKGROUND

• 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.

  PMID: 12821357 BACKGROUND

• 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.

  PMID: 36602237 BACKGROUND

• 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.

  PMID: 35339785 BACKGROUND

• 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 Dec;89(12):6290-6292. doi: 10.1177/00031348231156770. Epub 2023 Feb 14. No abstract available.

  PMID: 36787243 BACKGROUND

• 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.

  PMID: 27384094 BACKGROUND

• Nielsen S, Degenhardt L, Hoban B, Gisev N. A synthesis of oral morphine equivalents (OME) for opioid utilisation studies. Pharmacoepidemiol Drug Saf. 2016 Jun;25(6):733-7. doi: 10.1002/pds.3945. Epub 2015 Dec 22.

  PMID: 26693665 BACKGROUND

• Scarborough JE, Schumacher J, Kent KC, Heise CP, Greenberg CC. Associations of Specific Postoperative Complications With Outcomes After Elective Colon Resection: A Procedure-Targeted Approach Toward Surgical Quality Improvement. JAMA Surg. 2017 Feb 15;152(2):e164681. doi: 10.1001/jamasurg.2016.4681. Epub 2017 Feb 15.

  PMID: 27926773 BACKGROUND

• 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.

  PMID: 29016552 BACKGROUND

• 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.

  PMID: 33977334 BACKGROUND

• 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.

  PMID: 24893784 BACKGROUND

• 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.

  PMID: 23377782 BACKGROUND

• 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.

  PMID: 25503902 BACKGROUND

• 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.

  PMID: 30407319 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Benjamin Phillips, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Phillips, MD

CONTACT

215-955-5869; benjamin.phillips@jefferson.edu

Micaela L Collins, MD

CONTACT

micaela.collins@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 3, 2023
• Study Start: April 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)