| CTRI Number |
CTRI/2024/12/077580 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on effectiveness of WHO surgical safety checklist in patients undergoing laparoscopic operations in a big referral hospital |
|
Scientific Title of Study
|
To study the efficacy and outcome of WHO surgical safety checklist in laparotomy patients in a tertiary healthcare centre |
| 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 P Jagan Mohan Reddy |
| Designation |
Junior Resident |
| Affiliation |
HERITAGE INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of General Surgery,
NH2, GT Road Bypass,
Bhadwar,
Varanasi.
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
8977776278 |
| Fax |
|
| Email |
sunnyjaganreddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Mojeeb Ahsan |
| Designation |
General Surgeon |
| Affiliation |
HERITAGE INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room No. 111, Department of General Surgery, Heritage Institute of Medical Sciences, NH2, GT Road Bypass, Bhadwar,
VARANASI
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
9897884620 |
| Fax |
|
| Email |
mojeeb.ahsan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Jagan Mohan Reddy |
| Designation |
Junior Resident |
| Affiliation |
HERITAGE INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of General Surgery,
NH2, GT Road Bypass,
Bhadwar,
Varanasi.
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
8977776278 |
| Fax |
|
| Email |
sunnyjaganreddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Heritage Institute of Medical Sciences, NH2, GT Road Bypass, Bhadwar, Varanasi - 221311, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr P Jagan Mohan Reddy |
| Address |
Junior Resident,
Department of General Surgery,
Heritage Institute of Medical Sciences,
NH2, GT Road Bypass,
Bhadwar, Varanasi - 221311
Uttar Pradesh, India |
| 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 |
| Dr Jagan Mohan Reddy |
HERITAGE INSTITUTE OF MEDICAL SCIENCES |
Department of General Surgery,
NH2, GT Road Bypass,
Bhadwar, Varanasi - 221311.
Varanasi
UTTAR PRADESH |
8977776278
sunnyjaganreddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Heritage Institute of Medical Sciences |
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 |
WHOs Surgical safety checklist |
WHOs surgical safety checklist will be applied before surgical procedure in this group |
| Comparator Agent |
Without WHOs Surgical safety checklist |
WHOs safety checklist will not be applied before surgical procedure in this group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients presenting to Surgery department and undergoing laparotomy |
|
| ExclusionCriteria |
| Details |
Not willing for follow-up visits till 30 days |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical wellbeing and wound status |
Post-procedure
1 week
15 days
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intra-operative complications |
Periprocedure |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
16/12/2024 |
| 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="1"
Months="6"
Days="10" |
|
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
|
It is a randomized control trail (RCT) that
will be conducted at HIMS, Varanasi.
Patients presenting to Surgery dept and undergoing
laparotomy will be enrolled in the study.
Informed
consent in writing will be taken from all enrolled patients.
Study Objectives: To
compare the outcome in laparotomy patients in which surgical safety checklist
is used and in those where surgical safety checklist is not used.
To
compare the outcome in terms of surgical site infection, wound dehiscence,
hospital stay, antibiotic usage and mortality.
Postoperative
patients are followed up till 30 days
from date of discharge and complications are noted and compared with data of
patients checklist not used in laparotomy |