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CTRI Number  CTRI/2022/09/045958 [Registered on: 27/09/2022] Trial Registered Prospectively
Last Modified On: 11/10/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   Survival after exenteration surgery for rectal cancer 
Scientific Title of Study   Outcomes of Pelvic Exenteration in Rectal cancer: An Institutional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nizamudheen MP 
Designation  Associate Professor 
Affiliation  Malabar Cancer Centre, Thalassery 
Address  Malabar Cancer Centre Thalassery Kannur Kerala

Kannur
KERALA
670103
India 
Phone    
Fax    
Email  drnizamudheen@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vijayasarathy 
Designation  Senior Resident 
Affiliation  Malabar Cancer Centre, Thalassery 
Address  Malabar Cancer Centre Thalassery Kannur Kerala

Kannur
KERALA
670103
India 
Phone    
Fax    
Email  drvijiayasarathy1988@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vijayasarathy 
Designation  Senior Resident 
Affiliation  Malabar Cancer Centre, Thalassery 
Address  Malabar Cancer Centre Thalassery Kannur Kerala


KERALA
670103
India 
Phone    
Fax    
Email  drvijiayasarathy1988@gmail.com  
 
Source of Monetary or Material Support  
Malabar Cancer Center, Thalassery 
 
Primary Sponsor  
Name  Malabar Cancer Center 
Address  Thalassery, Kannur Kerala 
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 
Vijayasarathy S  Malabar Cancer Centre  Department of Surgical Oncology, Thalassery
Kannur
KERALA 		 9176618802

drvijayasarathy1988@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, Malabar cancer center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C20||Malignant neoplasm of rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients with rectal cancer who underwent pelvic exenteration in Malabar Cancer Center during the period Jan 2009- Dec 2020 
 
ExclusionCriteria 
Details  Second malignancy except non-melanomatous skin cancers 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Overall survival
Disease free survival
Recurrence rates will be assessed

 		 overall survival and disease-free survival at 3 yrs and 5 yrs 
 
Secondary Outcome  
Outcome  TimePoints 
morbidity and mortality rates  30 day morbidity and 30 day mortality 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   30/09/2022 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

OUTCOMES OF PELVIC EXENTERATION IN RECTAL CANCER: AN INSTITUTIONAL STUDY

  1. RESEARCH QUESTION

What are the factors predicting treatment outcomes and long term survival following pelvic exenteration for rectal cancer?


  1. AIMS AND OBJECTIVES

  2. AIM To evaluate long term survival and postoperative outcomes following pelvic exenteration for locally advanced primary and recurrent rectal cancer

  3. PRIMARY OBJECTIVE To determine the overall survival and disease free survival  To determine the morbidity and mortality rates following pelvic exenteration SECONDARY OBJECTIVE To determine prognostic factors associated with postoperative outcomes and survival.

  1. METHODOLOGY

  1. STUDY SETTING

Department of Surgical Oncology, Malabar Cancer Center, Thalassery


  1. STUDY DESIGN

Retrospective


  1. STUDY POPULATION

All patients with locally advanced primary and recurrent rectal cancer who underwent pelvic exenteration in MCC during the study period


  1. STUDY PERIOD

January 2009 - December 2020


  1. INCLUSION CRITERIA

  • Locally advanced or recurrent adenocarcinoma of rectum requiring pelvic exenteration


  1. EXCLUSION CRITERIA

  • Patients with second malignancy(except non-melanomatous skin cancer)


  1. DATA COLLECTION METHOD & SOURCE

Clinical data, treatment details and follow up data will be collected from the medical records division, MCC. 


  1. DEFINITIONS

Overall survival

Duration from date of registration to date of death or last follow up

Disease free survival

Duration from date of completion of surgery to date of recurrence or last follow up

Posterior pelvic exenteration

Resection of rectum, anal canal and uterus

Total pelvic exenteration

Resection of rectum, anal canal, uterus and bladder

Extended pelvic exenteration

Resection of structures additional to total exenteration like piriformis, sacrum

Customized pelvic exenteration

Resection extent lesser than posterior or total exenteration like prostate, vaginal wall

 
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