Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04848415
Other study ID # OCCLUS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date September 1, 2022

Study information

Verified date April 2021
Source Nantes University Hospital
Contact Philippe LE CONTE, PhD
Phone 33 2 40 28 39 34
Email philippe.leconte@chu-nantes.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

As reported in previous studies, Point-of-Care Ultrasound (POCUS) has good performance for the diagnosis of bowel obstruction even when compared with CT. This inexpensive, radiation-free tool is available in a majority of ED. It is performed at the patient's bedside with immediate results. The learning curve allows Emergency Physicians (EP) to perform this exam after a relative brief training period. The investigators aim to investigate the ability of POCUS performed before CT to exclude the diagnosis of bowel obstruction in patients admitted for abdominal pain.


Description:

Bowel obstruction (BO) is frequently suspected in the Emergency Department (ED). Computed Tomography (CT) is commonly used to diagnose this disease. However, CT is not always available in real-time, requires technician times, is associated with increased cost and exposes patients to radiations. The researchers will investigate the diagnosis performances of POCUS for the diagnosis of BO with comparison with CT which will be considered as the gold standard. The wain objective will be the ability to exclude the diagnosis of BO, the main criteria being the negative predictive value. The secondary objectives will be the diagnosis performances (sensitivity, specificity, positive predictive value), duration and difficulty of POCUS


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date September 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria : - Adult patients - Abdominal pain - Suspected bowel obstruction Exclusion Criteria : - Documented end-of-life precluding CT realization

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Point-of-Care Ultrasound
Patients admitted to the ED with abdominal pain and suspicion of bowel obstruction : realization of a Point-of-Care Ultrasound after clinical exam by the Emergency Physician in charge as a standard of care. Beside usual findings, the investigators will search for signs of bowel obstruction: dilated and incompressible small bowel loop, back-and-forth peristalsis sign. Determination of probability of small bowel obstruction. Realization of a computed tomography in search of small bowel obstruction.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Negative predictive value of POCUS Negative predictive value of POCUS for the diagnosis of bowel obstruction compared with computed tomography result Through ED stay, up to 24 hours
Secondary Positive predictive value of POCUS for the diagnosis of bowel obstruction Positive predictive value Through ED stay, up to 24 hours
Secondary Sensitivity of POCUS for the diagnosis of bowel obstruction sensitivity of POCUS, for the diagnosis of bowel obstruction compared with computed tomography result Through ED stay, up to 24 hours
Secondary Specificity of POCUS for the diagnosis of bowel obstruction specificity of POCUS, for the diagnosis of bowel obstruction compared with computed tomography result Through ED stay, up to 24 hours
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05442164 - Effect of Implementation of the Danish Emergency Surgery (DANAKIR) Support Network on Post-discharge Outcomes After Major Emergency Abdominal Surgery
Recruiting NCT04675606 - Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies N/A
Completed NCT04613063 - Proximal Intestinal Obstruction Syndrome (PIOS) in a Patient With Cystic Fibrosis: A New Syndrome
Recruiting NCT06089551 - Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery Phase 4
Completed NCT03202576 - Nasogastric Tube Securement Comparison Study N/A
Terminated NCT01507233 - A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B302 Phase 4
Completed NCT01040364 - Internal Hernias After Laparoscopic Gastric Bypass N/A
Terminated NCT01507220 - A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301 Phase 4
Completed NCT04898842 - Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet N/A
Not yet recruiting NCT05253222 - Methodology and Clinical Value of RIT in Intestinal Obstructive Diseases Mediated by Colonic TET N/A
Recruiting NCT04709445 - Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses N/A
Recruiting NCT04539028 - Emergency General Surgery for Non-trauma
Terminated NCT01911793 - Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery N/A
Recruiting NCT03150992 - EDMONd - Elemental Diet in Bowel Obstruction N/A
Terminated NCT02116881 - Incisional Hernia and Adhesion-Related Bowel Obstruction N/A
Recruiting NCT00164879 - Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers Phase 3
Completed NCT03350022 - Sham Feeding Post-operative Infants N/A
Not yet recruiting NCT03593252 - Bowel Preparation in Elective Pediatric Colorectal Surgery N/A
Completed NCT05753709 - Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Prospective Study N/A
Enrolling by invitation NCT05085353 - Fetal Outcomes Among Pregnant Emergency General Surgery Patients