Ileus PostoperativeNCT05796063
Postoperative Gastric Point of Care Ultrasound (G-POCUS) in Abdominal Surgery
A study testing gastric point of care ultrasound in people with Ileus Postoperative and Postoperative Nausea and Vomiting, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ileus Postoperative, Postoperative Nausea and Vomiting
- What is being tested?
- gastric point of care ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Micaela L Collins, MD contact
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Benjamin Phillips, MD
About this study
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?
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.
Read the 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.
- Being tested
- gastric point of care ultrasound
- Keywords
- gastric ultrasound, delayed bowel function, postoperative ileus
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric point of care ultrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The results from the intervention group will be compared to the control group (which will also proceed according to a standardized algorithm that reflects the current standard of care) to determine if there are differences in length of stay and aspiration pneumonia/pneumonitis between groups.
Measured: post-operative day 1 until day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Ileus PostoperativeStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Phillips, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796063
- Sponsor's protocol ID
- iRISID-2022-1082
- Status last verified
- Apr 2023
- First submitted
- 7 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20113944Bragg 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.
PubMed 25819420Gustafsson 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.
PubMed 21242424Gustafsson 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.
PubMed 30426190Haskins 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.
PubMed 30052550Heinberg 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.
PubMed 12821357Lamm 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.
PubMed 36602237Lamm 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.
PubMed 35339785Lamm 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.
PubMed 36787243Mirbagheri 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.
PubMed 27384094Nielsen 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.
PubMed 26693665Scarborough 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.
PubMed 27926773Schwenk 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.
PubMed 29016552Sommer 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.
PubMed 33977334Van 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.
PubMed 24893784
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT05796063
- Acronym / sponsor ID
- iRISID-2022-1082
- Keywords
- gastric ultrasound, delayed bowel function, postoperative ileus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: gastric point of care ultrasoundOn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastric point of care ultrasoundPatients 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. | Diagnostic test | Intervention |
Primary outcome
Utility of G-POCUS as a clinical decision-making tool - diet advancement
Time frame: post-operative day 1 until day of discharge from the hospital for patients in the intervention group
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.
1 secondary outcome
Utility of G-POCUS as a clinical decision-making tool - quality of care metrics
Time frame: post-operative day 1 until day of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Background: PubMed 20113944Asgeirsson 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.
- Background: PubMed 25819420Bragg 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.
- Background: PubMed 21242424Gustafsson 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.
- Background: PubMed 30426190Gustafsson 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.
- Background: PubMed 30052550Haskins 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.
- Background: PubMed 12821357Heinberg 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.
- Background: PubMed 36602237Lamm 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.
- Background: PubMed 35339785Lamm 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.
- Background: PubMed 36787243Lamm 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.
- Background: PubMed 27384094Mirbagheri 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.
- Background: PubMed 26693665Nielsen 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.
- Background: PubMed 27926773Scarborough 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.
- Individual participant dataSharing planned: No
Related trials for Ileus Postoperative
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micaela L Collins, MD contact
Benjamin Phillips, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gastric point of care ultrasound in people with Ileus Postoperative and Postoperative Nausea and Vomiting, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Phillips, MD (215-955-5869, benjamin.phillips@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility of G-POCUS as a clinical decision-making tool - diet advancement (time frame: post-operative day 1 until day of discharge from the hospital for patients in the intervention group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05796063, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.