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CTRI Number  CTRI/2021/02/031154 [Registered on: 09/02/2021] Trial Registered Prospectively
Last Modified On: 05/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   The effect of obesity in operations of cancer of the urogenital tract. 
Scientific Title of Study   Does obesity affect perioperative and postoperative outcomes in urological oncological surgeries? 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Skandh Bhatia 
Designation  Junior Resident 
Affiliation  Department of General Surgery, Kasturba Medical College, Manipal 
Address  Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD building, Kasturba Hospital, Manipal, Uudpi-576104

Udupi
KARNATAKA
576104
India 
Phone  8827217235  
Fax    
Email  skandh.bhatia@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena L Karanth 
Designation  Professor and Head of Unit 
Affiliation  Department of General Surgery, Kasturba Medical College, Manipal 
Address  Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD building, Kasturba Hospital, Manipal, Uudpi-576104

Udupi
KARNATAKA
576104
India 
Phone  9845417715  
Fax    
Email  veena.karanth@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Chitra Bhat 
Designation  Assistant Professor 
Affiliation  Department of General Surgery, Kasturba Medical College, Manipal 
Address  Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD building, Kasturba Hospital, Manipal, Uudpi-576104

Udupi
KARNATAKA
576104
India 
Phone  8618480414  
Fax    
Email  chitra.bhat@manipal.edu  
 
Source of Monetary or Material Support  
DEPARTMENT OF UROLOGY, KASTURBA HOSPITAL, MANIPAL 
 
Primary Sponsor  
Name  Dr Veena L Karanth 
Address  Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD building, Kasturba Hospital, Manipal, Uudpi-576104 
Type of Sponsor  Other [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 
SKANDH BHATIA  KASTURBA HOSPITAL, MANIPAL  Department of Urology, 1st floor, Smt. Sharada Madhav Pai OPD building, Kasturba Hospital, Manipal, Uudpi-576104
Udupi
KARNATAKA 		 8827217235

skandh.bhatia@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients undergoing surgery for any tumour of the urogenital origin. 
 
ExclusionCriteria 
Details  Patients below 18 years of age.
Patients unfit for surgery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The non obese group of patients is expected to have better peri and postperative outcome and a lesser rate of complications than the obese group  -Post operative day 2 to assess perioperative complications.
-After 1 week to assess other postoperative complications.
-The day of discharge if patient is planned for discharge before 1 week. 
 
Secondary Outcome  
Outcome  TimePoints 
The non obese group of patients is expected to have lesser severity of complications than the obese group.  -Post operative day 2 to assess perioperative complications.
-After 1 week to assess other postoperative complications.
-The day of discharge if patient is planned for discharge before 1 week. 
 
Target Sample Size   Total Sample Size="298"
Sample Size from India="298" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="136" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2021 
Date of Study Completion (India) 07/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response (Others) -  Peers involved in the manuscript review for publication and any regulatory authority.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  The Editor of the Journal or Head of the regulatory authority.

  6. For how long will this data be available start date provided 08-02-2021 and end date provided 08-02-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

It is a prospective observational study which will be conducted at Kasturba hospital, Manipal. A written informed consent will be taken from every patient who fits into the inclusion criteria for enrolment into the study. Proforma will be used to collect data from enrolled patients. A total of 136 patients who will undergo surgery for urological carcinoma at Kasturba hospital will be included in the study. The Body Mass Index will be calculated as per the Quetelet’s formula:BMI= Wt.(kgs)/Ht.2(Mts)

Standard data will be collected during patient’s admissions as part of routine clinical practice at our institution. Data will be extracted from this database. Observation of the patients will be done by using the data collection tool/proforma.

 
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