| CTRI Number |
CTRI/2024/03/063493 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A observational study to understand the effect of albumin level changes in respect to post surgical complication. |
|
Scientific Title of Study
|
A Study For Analysis of Pre And Post Operative Fluctuations
In Serum Albumin Levels As Predictor of Abdominal
Surgery Related Outcomes At UPUMS Saifai:A Follow Up 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 |
Atul Kumar |
| Designation |
Junior Resident |
| Affiliation |
UPUMS Saifai Etawah |
| Address |
R.N. 226 Department of General Surgery Department of General Surgery Etawah UTTAR PRADESH 206130 India |
| Phone |
7895900472 |
| Fax |
|
| Email |
yadavdratul343@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Anil Kumar |
| Designation |
Profesor |
| Affiliation |
UPUMS Saifai Etawah |
| Address |
Department of General Surgery UPUMS Saifai Department of General Surgery Etawah UTTAR PRADESH 206130 India |
| Phone |
9458409337 |
| Fax |
|
| Email |
profanilrims@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Atul Kumar |
| Designation |
Junior Resident |
| Affiliation |
UPUMS Saifai Etawah |
| Address |
R.N. 226 Department of General Surgery Department of General Surgery Etawah UTTAR PRADESH 206130 India |
| Phone |
7895900472 |
| Fax |
|
| Email |
yadavdratul343@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical science Saifai Etawah |
|
|
Primary Sponsor
|
| Name |
UPUMS Saifai Etawa |
| Address |
Saifai Etawah pin cod 206130 |
| 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 Atul Kumar |
Uttar Pradesh University of Medical Science Saifai Etawah pin 206130 Saifai Etawah |
R.N. 226 Department of Surgery Etawah UTTAR PRADESH |
7895900472
yadavdratul343@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Uttar Pradesh University of Medical Sciences Saifai,Etawah |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patient who will undergo abdominal surgery. |
|
| ExclusionCriteria |
| Details |
Age below 14 years old and above 70 years old
Patient who got Albumin correction.
Patient with liver cirrhosis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establishment of serum albumin changes with respect to post abdominal surgery outcomes. |
Albumin level will be note 24 hour prior operative procedure and after that 24 hour interval with outcomes till post operative day 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
t will be easy to predict the outcome of surgery related complications
that might help in selection of procedure in pre op period. |
At the time of result. |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
12/03/2024 |
| 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="1" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Aoife M Ryan et al (2007) The aim of this study
was to determine if the absolute albumin level on the first postoperative day
was of value in predicting in-hospital complications. A
retrospective study of 200 patients undergoing esophagectomy for malignant
disease at St. James Hospital between 1999 and 2005 was performed . Serum
albumin concentration on the first postoperative day is a better predictor of
surgical outcome than many other preoperative risk factors. It is a low cost
test that may be used as a prognostic tool to detect the risk of adverse
surgical outcomes.
Gaetan-Romain Joliat
et al(2022) Postoperative
complications are frequent after gastrointestinal surgery and early prediction
remains an unmet need. Serum albumin shows a rapid decrease after surgery, and
this decline (ΔAlb) may reflect the intensity of the surgical stress response
and thereby be a predictor of postoperative complications. This study aimed to
comprehensively review the available data on ΔAlb in gastrointestinal surgery.
PRISMA guidelines were followed to conduct a systematic review of the
literature in MEDLINE and Embase. Studies assessing the role of ΔAlb to predict
complications after gastrointestinal surgery were included. Alb appeared as a
valuable and promising biomarker to anticipate complications after
gastrointestinal surgery. Future efforts are needed to determine whether and
how ΔAlb may be integrated in clinical practice to guide clinicians in the
perioperative management of patients.
"Now in this Study we
are going to evaluate incidence of particular complication with respect to
change in Albumin level" |