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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified, |
|
Intervention / Comparator Agent
|
|
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.
|