| CTRI Number |
CTRI/2024/08/072115 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of outcome in patients with hypoalbuminemia in postoperative period after major abdominal surgeries |
|
Scientific Title of Study
|
Assessment of Outcome in Patients with Hypoalbuminemia in Postoperative Period after Major Abdominal
Surgeries. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushbu Hemant Vaidya |
| Designation |
Junior Resident |
| Affiliation |
Datta meghe institute of higher education and research |
| Address |
General surgery department , Jawaharlal nehru medical college, sawangi(meghe),wardha , pincode-442004, maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
8141064052 |
| Fax |
|
| Email |
khushbu179506@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RK SHINDE |
| Designation |
professor |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi(Meghe), Wardha |
| Address |
General surgery department , jawaharlal nehru medical college , sawangi (meghe) , wardha , pincode-442004, maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
8087148087 |
| Fax |
|
| Email |
raju.shinde95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RK SHINDE |
| Designation |
professor |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi(Meghe), Wardha |
| Address |
DEPT OF GENERAL SURGERY, JNMC, DMIHER SAWANGI (MEGHE)
Wardha
MAHARASHTRA
442004
India |
| Phone |
8087148087 |
| Fax |
|
| Email |
raju.shinde95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher education and research, Sawangi (meghe), wardha, Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Khushbu Hemant Vaidya |
| Address |
Datta Meghe Institute of Higher education and research, Sawangi (meghe), wardha, Maharashtra, India 442001 |
| 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 |
| Dr Khushbu hemant vaidya |
Acharya vinoba bhave rural hospital |
Department of General Surgery, Acharya vinoba bhave rural hospital, sawangi (meghe), wardha, Maharashtra, India, pincode-442001
Wardha
MAHARASHTRA |
8141064052
khushbu179506@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing major abdominal surgeries and that in the age group of 18-70 years were
included.
o Patient with known co-morbidities that are corrected |
|
| ExclusionCriteria |
| Details |
o Patient of either abdominal emergency surgery with uncontrolled co-morbidities.
o Patient with liver diseases, and kidney diseases (Failure).
o Patient with sepsis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1-To estimate the serum albumin level in major elective abdominal surgeries on pre operative day and postoperative day 1 and day 3 and day 5
2-correlation of serum albumin level with outcome pre operative day and postoperative day 1 and day 3 and day 5
|
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-Correlation of hospital stay with albumin & INR & CRP levels
2- Association of outcomes with albumin & INR & CRP levels on day of discharge & after 15 days of discharge & after 30 days of discharge
3-average day of discharge in patient with hypoalbuminemia & without hypoalbuminemia |
30 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The present study is aimed to examine the level of albumin pre post-operative level in the context of predicted complications of surgeries in patients undergoing major abdominal surgeries Objective is to estimate the serum albumin level in major elective abdominal surgeries, To estimate the serum albumin level on post-operation day 1.3 & 5 and To correlate complications, like wound healing & leak of anastomosis This study will include a patient who is eligible for above mention inclusion criteria after signing an informed consent especially designed proforma will be filled by each patient with proforma having general information about the patient, pre, and post-operative albumin level. First on the day of admission sr. albumin and CRP levels will be measured. Postoperatively sequential measurements of sr. Alb & CRP will be conducted on day 1, 3 and 5. On the basis of the obtained levels of S.A & CRP: the increment & decrement in the levels will be evaluated followed by corrections if needed will be provided to the pt. Outcome Wound Infection Wound Dehiscence Anastomotic Leak Intra-Abdominal Abscess The representative abdominal procedure included in this study will be: A. Open or laparoscopic cholecystectomy B. Upper GI resection like bypass surgeries, gastrectomy, esophagectomy, resection anastomosis. Liver and pancreatic surgery D. Urological procedure. E. Gastric Tumor surgeries F. Exploratory laparotomy |