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CTRI Number  CTRI/2024/11/077378 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   External validation of SORT- a surgical outcome risk tool in patients undergoing open abdominal surgery at an Indian tertiary hospital center. 
Scientific Title of Study   External validation of surgical risk assessment tool(SORT) in predicting perioperative mortality in patients undergoing exploratory laparotomy surgery at an Indian tertiary care center and its possible feasibility in predicting postoperative morbidity. 
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 Rohan Shashi Patil 
Designation  Junior Resident 
Affiliation  KMC Manipal 
Address  Department of General surgery, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576401
India 
Phone  7798888627  
Fax    
Email  rohan.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bharath SV 
Designation  Associate professor 
Affiliation  Scientific query person 
Address  Department of General surgery, Kasturba Hospital, Manipal. Manipal Academy of Higher Education, Manipal
Department of General surgery, Kasturba Hospital, Manipal. Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576401
India 
Phone  9611203140  
Fax    
Email  bharath.sv@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Rohan Shashi Patil 
Designation  Junior Resident 
Affiliation  KMC Manipal 
Address  Department of General surgery, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576401
India 
Phone  7798888627  
Fax    
Email  rohan.kmcmpl2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba medical college, Manipal, Udupi, Karnataka, India 576104 
 
Primary Sponsor  
Name  Rohan Patil 
Address  Dept. Of General Surg, KMC Manipal, Udupi, Karnataka, India 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRohan Patil  Kasturba Hospital   General surgery OPD room no. 4, Manipal, Udupi, Karnataka, India 576104
Udupi
KARNATAKA 
7798888627

rohan.kmcmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical college/Kasturba Hospital Institutional EthicalCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 interventions. At no point - will patients be divided into 2 groups (cases and control groups). There is no randomisation. All data that will be taken for the study will be completely observational from patients files and charts. No data for the study will involve any intervention. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1)patients undergoing exploratory laparotomy in department of general surgery, Dept. of GIS and Dept. Surgical oncology.
2)Patients consenting to be part of study. 
 
ExclusionCriteria 
Details  1)Patients not willing to be part of study.
2)Patient lost to follow up. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sensitivity, specificity and independent t value of SORT as tool to look for its validation in Indian tertiary care center.  For each patient will be followed up on day- 1,3,7,10, 1month 
 
Secondary Outcome  
Outcome  TimePoints 
Post-op morbidities will be looked for like- Surgical site infection, intra abdominal collection, paralytic ileus, enterocutenous fistula, atelectasis, urinary tract infection, abdominal wall dehiscience or incisional hernia   Each patient will be followed up on day-1,3,7,10,30th day to check on postoperative morbidity based on per abdominal findings, vital parameters like BP,pulse, spo02, drain tube collection, fluid input/output, ryles tube output. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   28/11/2024 
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 Applicable 
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  

Single centre, Prospective, observational - longitudinal, Non-randomized. All the patients undergoing exploratory laparotomy participate in this study. This study will be conducted in Department of General Surgery, Department of Gastrointestinal surgery and Department of Surgical Oncology, Kasturba hospital, Manipal. The purpose of study is to externally validate- SORT(surgical outcome risk tool) in predicting post operative mortality in exploratory laparotomy based on following tool parameters â€“ procedure code, operation severity, American Society of Anaesthesiologists’ physical status classification (ASA), clinical urgency, surgical site (thoracic, gastrointestinal or vascular surgery), cancer (active malignancy within the last 5 years) and age, all of which are available pre-operatively.

After patients have consented for this study, we will extract and included demographic data and clinical data. 

We will also follow-up on, intra-op findings, postoperative clinicaland laboratory details during hospital stay on day-1, day-3, day-7, day 10 and day of dischargeIf patient is discharged before 30 days post-op periodwe’ll be following up via telephonic conversation on post-op 30th day regarding general condition of patient. We’ll define mortality as any patient death that occurring during the first 30 days or during the hospital stay if longer than 30 days. The predicted risk of mortality will be calculated using the SORT models.

And same scores will be used to check SORT’s very feasibility in predicting postoperative morbidity in patients undergoing same procedure.

 
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