| CTRI Number |
CTRI/2026/04/107284 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying What happened to patients with low serum albumin if undergoing emergency laparotomy |
|
Scientific Title of Study
|
A prospective observational study of association of serum albumin level with occurrence of complications in patients undergoing emergency laparotomy |
| 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 Vinod Arajanbhai Prajapati |
| Designation |
Post graduate resident |
| Affiliation |
Department of general surgery Government medical college BHAVNAGAR |
| Address |
Department of general surgery government medical college BHAVNAGAR
Dr Hemant vaidhya road kalanala panwadi BHAVNAGAR
Bhavnagar
GUJARAT
364001
India |
| Phone |
9979692738 |
| Fax |
|
| Email |
vinodprajapati102046@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smit Mehta |
| Designation |
Assistant professor |
| Affiliation |
Department of general surgery Government medical college BHAVNAGAR |
| Address |
Department of general surgery government medical college BHAVNAGAR
Dr Hemant mehta road kalanala panwadi BHAVNAGAR
Bhavnagar
GUJARAT
364001
India |
| Phone |
8905735051 |
| Fax |
|
| Email |
dr.smitmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smit Mehta |
| Designation |
Assistant professor |
| Affiliation |
Department of general surgery Government medical college BHAVNAGAR |
| Address |
Department of general surgery government medical college BHAVNAGAR
Dr Hemant Mehta road kalanala panwadi BHAVNAGAR
Bhavnagar
GUJARAT
364001
India |
| Phone |
8905735051 |
| Fax |
|
| Email |
dr.smitmehta@gmail.com |
|
|
Source of Monetary or Material Support
|
| General surgery department government medical college BHAVNAGAR gujarat india 364001 |
|
|
Primary Sponsor
|
| Name |
Dr Vinod Arajanbhai Prajapati |
| Address |
General surgery department government medical college BHAVNAGAR gujarat india 364001 |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Vinod Prajapati |
Sir T general hospital BHAVNAGAR gujarat india 364001 |
Department of general surgery government medical college BHAVNAGAR
Bhavnagar
GUJARAT |
9979692738
vinodprajapati102046@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patient with age greater than and equal to 18 undergoing emergency laparotomy |
|
| ExclusionCriteria |
| Details |
If re operation within 30 days of initial laparotomy
If patient is already taking albumin therapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient Complications developed |
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Death
Discharged
|
15 months |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
11/04/2026 |
| 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="3"
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
|
By this study I will come to know that person with low serum albumin if undergoing emergency laparotomy then which post operative Complications he or she is going to encounter and with its associated age wise comparison duration of hospital stay discharge death |