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CTRI Number  CTRI/2024/05/066684 [Registered on: 02/05/2024] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Microbiological profile in perforation peritonitis 
Scientific Title of Study   To study microbiological profile in perforation peritonitis with respect to anatomical site of perforation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MUSLIHATH K P 
Designation  Post graduate resident 
Affiliation  Atal Medical and Research University, Himachal Pradesh 
Address  Department of General Surgery Indhira Gandhi Medical College Shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  8770826583  
Fax    
Email  MUSLIHAUSMAN@GMAIL.COM  
 
Details of Contact Person
Scientific Query  
Name  Dr Ved Sharma 
Designation  Associate professor 
Affiliation  Atal Medical and Research University, Himachal Pradesh 
Address  Department of General Surgery Indhira Gandhi Medical College Shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418477766  
Fax    
Email  drvksharma6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ved Sharma 
Designation  Associate professor 
Affiliation  Atal Medical and Research University, Himachal Pradesh 
Address  Department of General Surgery Indhira Gandhi Medical College Shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418477766  
Fax    
Email  drvksharma6@gmail.com  
 
Source of Monetary or Material Support  
Department of General Surgery Indhira Gandhi Medical College Shimla 
 
Primary Sponsor  
Name  Self 
Address  DEPARTMENT OF GENERAL SURGERY, IGMC SHIMLA UG AND PG HOSTEL IGMC SHIMLA 
Type of Sponsor  Government medical college 
 
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 
Dr MuslihathK P  General Surgery department  Indhira Gandhi Medical College Shimla Shimla
Shimla
HIMACHAL PRADESH 		 8770826583

muslihausman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Instituitional Committee IGMC, Shimla  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K638||Other specified diseases of intestine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  patient more than 18 years presenting with perforation peritonitis 
 
ExclusionCriteria 
Details  Patient with immunocompromised states
diabetes mellitus
Multiple areas of perforation
Gynecological causes of perforation
patient managed with intra abdominal drain pre operatively.
Age less than 18 years excluded.
Pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate association between perforation peritonitis and microbiological profile at presentation intraoperatively and post op outcome.  to estimate association between perforation peritonitis and microbiological profile at presentation intraoperatively and post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
To study outcomes (wound sepsis, discharge or death) of perforation peritonitis post operatively
 		 Post operative period 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   20/05/2024 
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="0"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  Study result

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response (Others) -  on request

  4. For what types of analyses will this data be available?
    Response (Others) -  future study references

  5. By what mechanism will data be made available?
    Response (Others) -  on request

  6. For how long will this data be available start date provided 08-05-2024 and end date provided 22-04-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Patient coming to emergency room with perforation peritonitis are recruited considering the inclusion and exclusion criteria, after due verbal consent and admitted to department of general surgery.  
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