| CTRI Number |
CTRI/2025/07/092123 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see effect of validity of one scoring system in predicting complications after surgery |
|
Scientific Title of Study
|
Validation of American College of Surgeons National Surgical Quality Improvement Programme Surgical risk calculator scoring in predicting the adverse outcomes and postoperative complications in indian patients undergoing elective surgeries – 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 |
singam geetha |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute of Medical Sciences Hyyderabad: Pincode: 500082 |
| Address |
Department of Anaesthesia
OT3
specality block
Nizams Institute of Medical Sciences
Panjagutta
Hyderabad
Telangana
Hyderabad
TELANGANA
500082
India |
| Phone |
09441043075 |
| Fax |
|
| Email |
singamgeetha11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vanaja valapala |
| Designation |
Senior Resident |
| Affiliation |
Nizams Institute of Medical Sciences Hyyderabad: Pincode: 500082 |
| Address |
Department of Anaesthesia
Room no: 5
Specality block
Nims
Panjagutta
Hyderabad
Telangana
Hyderabad
TELANGANA
500082
India |
| Phone |
08688288733 |
| Fax |
|
| Email |
valapalavanaja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
singam geetha |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute of Medical Sciences Hyyderabad: Pincode: 500082 |
| Address |
Department of Anaesthesia
OT3
specality block
Nizams Institute of Medical Sciences
Panjagutta
Hyderabad
Telangana
Hyderabad
TELANGANA
500082
India |
| Phone |
09441043075 |
| Fax |
|
| Email |
singamgeetha11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Singam Geetha |
| Address |
OT3
specality block
Nizams Institute Of Medical Sciences
Hyderabad |
| 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 |
| Singam Geetha |
Nizams Institute of Medicel sciences |
Department of Anaesthesia
OT3
specality block
Nims
Panjagutta
Hyderabad
Telangana
Hyderabad
TELANGANA |
09441043075
singamgeetha11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nims institutional Ethics Commitee |
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 |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All elective surgeries done under general anaesthesia/ spinal anaesthesia/epidural anaesthesia/combined spinal -epidural anaesthesia |
|
| ExclusionCriteria |
| Details |
patients refusal
pregnant women
emergency indication
surgeries under local anaesthesia
ENT, opthalmic surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see Validation of ACS NSQIP SRC Scoring in predicting the adverse outcomes and postoperative complications |
preop to postop 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see the efficacy of NSQIP sore on predicting less common and serious complications |
preop to opstop 30 days |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
11/08/2025 |
| 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="0"
Months="3"
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
|
500 people undergoing various elective surgeries will be recruited after institute ethics approval, CTRI registration and patients written informed consent. Demographic and clinical data including 20 specific risk factors will be entered into online ACS NSQIP risk calculator. Preoperative characteristics and the current procedural terminology code (CPT) will be entered for each patient seperately.. The results of the calculator will include all complications including serious complications. Followup of all these complications will be done postop in ICU, ward, cilinic, personal phone calls .And the incidence of all these complications will be noted as gold standard for this study. And the validity of this NSQIP score in predicting this score will be noted |