| 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
|
|
|
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
|
|
|
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 – 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 discharge. If patient is discharged before 30 days post-op period, we’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. |