| CTRI Number |
CTRI/2025/07/091625 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study on sudden blockage of the intestines |
|
Scientific Title of Study
|
A prospective study of acute intestinal obstruction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek Sharma |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Room no 66 pg boys hostel no 4 Varunarjun medical college shahjahanpur road banthra
Room no 178 opd Department of surgery Varunarjun medical college shahjahanpur road banthra
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
07387384121 |
| Fax |
|
| Email |
sharma.abhishek86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R V Bhosle |
| Designation |
Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of surgery Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
09850642668 |
| Fax |
|
| Email |
bhosleraghuveer123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R V Bhosle |
| Designation |
Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of surgery Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
UTTAR PRADESH
242307
India |
| Phone |
09850642668 |
| Fax |
|
| Email |
bhosleraghuveer123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of surgery Varun arjun medical college and rohilkhand hospital lucknow road banthara district shahjahanpur Shahjahanpur
UTTAR PRADESH
242307 India |
|
|
Primary Sponsor
|
| Name |
Dr Abhishek Sharma |
| Address |
Department of surgery Varun arjun medical college and rohilkhand hospital lucknow road banthara district shahjahanpur Shahjahanpur
UTTAR PRADESH
242307 India |
| Type of Sponsor |
Private medical college |
|
|
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 Abhishek Sharma |
Rohilkhand Hospital Banthara Shahjahanpur |
Department of Surgery Varun Arjun Medical College Banthara Shahjahanpur Uttar Pradesh India Shahjahanpur
UTTAR PRADESH
Shahjahanpur
UTTAR PRADESH |
07387384121
sharma.abhishek86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Varun Arjun Medical College and Rohilkhand Hospital NH24 Banthara shahjahanpur Uttar Pradesh 242307 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
standard management of acute intestinal obstruction |
all patients managed according to hospital protocol initial resuscitation diagnostic imaging decision for conservative versus surgical intervention based on clinical judgement and image findings |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
This study included patients who had a sudden blockage in the intestines confirmed by tests like X ray CT scan or during surgery
It focused on people aged 18 to 60 years divided into three groups 18 to 30 31 to 45 and 46 to 60 years Only those who gave permission to take part were included
The study looked at both types of blockage one caused by a physical problem called mechanical and the other without a physical block such as paralytic ileus
Patients had common symptoms such as stomach pain vomiting constipation and swelling of the abdomen |
|
| ExclusionCriteria |
| Details |
Patients were excluded from the study if they had undergone recent abdominal surgery within the past 30 days to avoid confusion with postoperative ileus those with chronic conditions affecting bowel movement like intestinal pseudo obstruction or motility disorders were also not included pregnant women were excluded to avoid risks to the fetus and because pregnancy can change how the body responds to illness patients with serious health problems such as severe heart disease or kidney failure were also left out to prevent complications or unclear results in addition anyone unable to give informed consent and without a legal representative was excluded finally patients who were unlikely to follow the study plan or attend follow-up visits were also not included |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the most common causes of acute intestinal obstruction and assess the effectiveness of different management strategies based on patient recovery symptom resolution and hospital stay duration |
3month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the accuracy of diagnostic methods imaging and clinical tools analyze variations in clinical presentation by age and cause monitor complications such as bowel ischemia or perforation and assess short term and long term outcomes including mortality recurrence and quality of life post treatment |
3month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/08/2025 |
| 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="0"
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
|
This prospective study aims to understand acute intestinal obstruction by examining its causes symptoms diagnosis treatment methods complications and outcomes The objectives include identifying common causes like adhesions or hernias analyzing how symptoms vary with different causes and age groups comparing the effectiveness of diagnostic tools like X-rays and CT scans and evaluating both conservative and surgical treatments The study also looks at complications such as bowel ischemia and assesses both short-term and long-term outcomes The goal is to improve patient care and develop better treatment guidelines |