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CTRI Number  CTRI/2019/11/022010 [Registered on: 14/11/2019] Trial Registered Prospectively
Last Modified On: 14/11/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Forward in time study, to determine the association of pre-operative nutritional status with the 90 days post-operative complications among patients undergoing urinary bladder removal surgery 
Scientific Title of Study   Prospective cohort study to determine the association of pre-operative nutritional status with 90 days morbidity among patients undergoing Radical cystectomy for Muscle Invasive Bladder Cancer 
Trial Acronym  Pre-Nut MARC 
Secondary IDs if Any  
Secondary ID  Identifier 
3101_v.2.0_dated 08.10.2019  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ganesh Bakshi 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Surgical Oncology (Urology), Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  0224176228  
Fax    
Email  bakshigk@tmc.gov.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ganesh Bakshi 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Surgical Oncology (Urology), Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  0224176228  
Fax    
Email  bakshigk@tmc.gov.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ganesh Bakshi 
Designation  Professor, Department of Surgical Oncology (Urology) 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai 400012
Dr. E Borges Marg, Parel, Mumbai 400012

MAHARASHTRA
400012
India 
Phone  0224176228  
Fax    
Email  bakshigk@tmc.gov.in  
 
Source of Monetary or Material Support  
Tata Memorial Centre, Dr E Borges Marg, Parel, Mumbai 400012, Maharashtra 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Dr. E Borges Marg, Parel, Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
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 Ganesh Bakshi  Tata Memorial Centre  Dr. E Borges Marg, Parel, Mumbai 400012
Mumbai (Suburban)
MAHARASHTRA 
9869331584

bakshigk@tmc.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adult patients [age ≥ 18 years].
2. Planned for Radical cystectomy.
3. Patients who can read,write and
understand English language.
4. Who give written informed consent
 
 
ExclusionCriteria 
Details  1. Patients unfit/unwilling for surgery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To correlate the preoperative nutritional status with the 90 days morbidity in patients undergoing radical cystectomy for muscle invasive bladder cancer.  pre-operative nutritional status recorded upto within one week prior to surgery and morbidity upto 90 days post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the effect of the preoperative nutritional status on the peri-operative parameters - duration of surgery, estimated blood loss, amount of blood transfused.  During radical cystectomy. 
2. To assess the effect of the pre-operative nutritional status on the length of hospital stay, readmission rates and the day of ureteric stent removal.  From day of surgery upto 90 days post-operatively 
3. To determine the prevalence of pre-operative poor nutritional status among the patients undergoing radical cystectomy.  Once within one week prior to surgery  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   14/11/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   We intend to publish the results post completion of the study, at conferences and leading journals.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Bladder cancer is among the top ten cancers in the world. Muscle invasive bladder cancer constitutes of approximately one-fourth of the total bladder cancers. Radical cystectomy which is the gold standard treatment for bladder cancer is associated with higher morbidity and mortality. Also nutritional status of patients is associated with post surgical recovery of patients. Most of the literature on association of pre-operative malnutrition and post radical cystectomy complications comes from retrospective studies. Therefore we intend to perform a prospective cohort study to assess the association of pre-operative nutritional status and 90 days morbidity in patients undergoing radical cystectomy.


 
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