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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  
Nil 
 
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  
Status 
Not Applicable 
 
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 Trial

Post-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.

 
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