| CTRI Number |
CTRI/2025/10/096243 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
longitudinal analytical study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find which scoring method better predicts recovery and complications after major abdominal surgery |
|
Scientific Title of Study
|
Comparison of Modified surgical APGAR Score and ASAPS classification in predicting postoperative complications in patients undergoing 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 Tushar Sherasiya |
| Designation |
junior resident |
| Affiliation |
bharati vidyapeeth deemed to be university |
| Address |
Major operation theatre,
3rd floor, Bharati
Hospital and Research
Centre, pune-satara
road, pincode:411043
Pune
MAHARASHTRA
Pune MAHARASHTRA 411043 India |
| Phone |
9825724810 |
| Fax |
|
| Email |
tusharserasiya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shilpa Acharya |
| Designation |
Professor |
| Affiliation |
bharati vidyapeeth deemed to be university |
| Address |
Major operation theatre,
3rd floor, Bharati
Hospital and Research
Centre, pune-satara
road, pincode:411043
Pune
MAHARASHTRA
Pune MAHARASHTRA 411043 India |
| Phone |
9850900632 |
| Fax |
|
| Email |
drshilpaacharya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shilpa Acharya |
| Designation |
Professor |
| Affiliation |
bharati vidyapeeth deemed to be university |
| Address |
Major operation theatre,
3rd floor, Bharati
Hospital and Research
Centre, pune-satara
road, pincode:411043
Pune
MAHARASHTRA
MAHARASHTRA 411043 India |
| Phone |
9850900632 |
| Fax |
|
| Email |
drshilpaacharya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Tushar Sherasiya |
| Address |
Major operation theatre,
3rd floor, Bharati
Hospital and Research
Centre, pune-satara
road, pincode:411043
Pune
MAHARASHTRA |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr shilpa Acharya |
Major operation theatre,
3rd floor, Bharati
Hospital and Research
Centre, pune-satara
road, pincode:411043
Pune
MAHARASHTRA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tushar Sherasiya |
bharati hospital and research center |
Department of Anaesthesia Bharati Vidyapeeth Deemed to be
University Pune
Pune
MAHARASHTRA
411043
India Pune MAHARASHTRA |
9825724810
tusharserasiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z488||Encounter for other specified postprocedural aftercare, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults between 18–65 years undergoing elective or emergency laparotomy |
|
| ExclusionCriteria |
| Details |
Pregnant patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of mSAS in predicting post-operative complications within 30 days |
30 days post-surgery (inpatient + telephonic follow-up on day 0, 7, 15, 30) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="123" Sample Size from India="123"
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)
|
30/10/2025 |
| 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="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
|
Background and Purpose of the TrialPost-operative complications significantly affect surgical outcomes, recovery, and overall patient safety. Accurate preoperative and intraoperative risk assessment is crucial for optimizing perioperative management and resource allocation. The American Society of Anesthesiologists Physical Status (ASA-PS) classification is widely used to assess a patient’s preoperative health and comorbidities, but it does not fully account for intraoperative physiological changes. In contrast, the Modified Surgical Apgar Score (mSAS) evaluates real-time intraoperative parameters—such as estimated blood loss, mean arterial pressure, and heart rate—allowing dynamic risk prediction immediately after surgery. However, limited evidence exists comparing the predictive accuracy of these two scoring systems in patients undergoing laparotomy, a major abdominal procedure associated with significant morbidity.
This study aims to compare the Modified Surgical Apgar Score (mSAS) and ASA-PS classification in predicting post-operative complications in laparotomy patients. By identifying which system more accurately predicts adverse outcomes, the study seeks to enhance perioperative risk stratification, guide early interventions, and ultimately improve patient outcomes. |