| CTRI Number |
CTRI/2025/10/096478 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
26/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking for bowel blockage using bedside ultrasound in the emergency room: How well does it work |
|
Scientific Title of Study
|
Diagnostic accuracy of point of care Ultrasound for detecting small bowel obstruction in Emergency Department A Prospective Observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammed Fahad |
| Designation |
Junior Resident |
| Affiliation |
AIIMS BHOPAL |
| Address |
3rd floor
Trauma and Emergency Medicine department
AIIMS Bhopal
Bhopal MADHYA PRADESH 462020 India |
| Phone |
94968439841 |
| Fax |
|
| Email |
mohammed.jr2025@aiimsbhopal.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Saurabh Trivedi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS BHOPAL |
| Address |
3rd floor
Trauma and Emergency Medicine
AIIMS Bhopal
Bhopal MADHYA PRADESH 462020 India |
| Phone |
7042461338 |
| Fax |
|
| Email |
saurabh.tem@aiimsbhopal.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Mohammed Fahad |
| Designation |
Junior Resident |
| Affiliation |
AIIMS BHOPAL |
| Address |
3rd floor
Trauma and Emergency Medicine
AIIMS Bhopal
Bhopal MADHYA PRADESH 462020 India |
| Phone |
94968439841 |
| Fax |
|
| Email |
mohammed.jr2025@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS BHOPAL
saket Nagar,Bhopal,India
PIN:462020 |
|
|
Primary Sponsor
|
| Name |
AIIMS BHOPAL |
| Address |
Saket Nagar
462020 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohammed Fahad |
AIIMS BHOPAL |
1st floor
Trauma and Emergency Medicine department Bhopal MADHYA PRADESH |
94968439841
drfahadmhd7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee- Student Research (IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R100||Acute abdomen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients aged 18 to 65 years, presenting to the emergency department with symptoms and signs suggestive of small bowel obstruction, including but not limited to:
i. Abdominal pain
ii. Abdominal distension
iii. Nausea and vomiting
iv. Changes in bowel habits (e.g., obstipation)
b. Patients (or legal guardians) providing informed consent for participation in the study. |
|
| ExclusionCriteria |
| Details |
i. Patients with hemodynamic instability precluding POCUS.
ii. Patients with known intra-abdominal malignancy or inflammatory bowel disease.
iii. Patients with a recent history of abdominal surgery (within the past 30 days)
iv. Patients who are not consenting for Ultrasound examination
v. Patients in whom CECT scan is not feasible
vi. Patients who have deranged Renal function Test.
vii .Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome
•
Diagnostic accuracy of individual POCUS features for small bowel obstruction diagnosis. |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Diagnostic accuracy of the combined POCUS criteria.
Diagnostic accuracy of POCUS compared to CECT & X-ray.
Time-to-diagnosis (from triage to definitive diagnosis) for each modality.
Predictive value of combinations of POCUS features using logistic regression or ROC analysis. |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="91" Sample Size from India="91"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Small bowel obstruction is a common and potentially life-threatening surgical emergency frequently encountered in the emergency department. Patients often present with colicky abdominal pain, vomiting, abdominal distension, and failure to pass flatus or feces. The most common etiologies of SBO differ by region, however ,intra abdominal adhesions following prior surgery remain the leading cause in developed countries, as per both sources .Other causes include hernias, neoplasms, Crohn’s disease, volvulus, and intussusception .In recent years, point-of-care ultrasonography (POCUS) has emerged as a valuable, non-invasive, bedside tool in the emergency setting. The approach is novel in it broad age range and focus on patients with clinical features of small bowel obstruction with bed side ultrasound abdominal examination and comparing with computed tomography reports. Studies have shown that with appropriate training, emergency physicians can effectively use bedside USG to detect signs of SBO, such as dilated bowel loops, abnormal peristalsis, and transition points .Key Ultrasound Features for Diagnosing SBO includes Dilated Small Bowel Loops: Diameter >2.5 cm, Altered Peristalsis: Hyperperistalsis in early stages as the bowel attempts to overcome the blockage. Hypoperistalsis or absent peristalsis in late or ischemic stages, Identification of the Transition Point :Crucial for determining the exact site of obstruction, Bowel Wall thickness >3 mm, Presence of Free Fluid: Anechoic fluid around bowel loops or in the abdomen, Whirl sign: Suggests volvulus or twisted mesentery. Target sign: May indicate intussusception. In this study, the aim is to investigate the diagnostic accuracy of pocus for detecting small bowel obstruction in emergency department patients compared to x ray and Computed Tomography findings .By examining these, we seek to understand whether point of care ultrasound can use non-invasive tool for rapid assessment of small bowel obstruction in Emergency department .X ray ABDOMEN Findings includes Dilated small bowel loops : More than 3 cm in diameter, Air-fluid levels:. Multiple levels with a "step-ladder" appearance, Paucity of gas in the colon and rectum :Suggests distal obstruction, "String of beads" sign: Small pockets of air trapped between valvulae conniventes in a fluid-filled bowel loop .Seen best on supine films, Valvulae conniventes :Thin, closely spaced mucosal folds that traverse the full width of the bowel .CT ABDOMEN FINDINGS includes Dilated small bowel loops Diameter >2.5–3 cm, Collapsed distal bowel and colon, Transition point :The area where dilated bowel suddenly becomes collapsed, "Small bowel feces sign "Mottled gas and particulate matter in the lumen, suggesting stasis of contents ,Air-fluid levels, Strangulation or ischemia indicators :Bowel wall thickening (>3 mm), Closed-loop obstruction: U-shaped or C-shaped loop of dilated bowel. "Whirl sign" of twisted mesentery. |