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CTRI Number  CTRI/2024/09/073200 [Registered on: 02/09/2024] Trial Registered Prospectively
Last Modified On: 28/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Best outcome of pelvic exenteration for rectal cancer - An International Multicentre Study 
Scientific Title of Study   International Benchmarking Study of Pelvic Exenteration for Rectal Cancer (BeSt-PE) 
Trial Acronym  BeSt-PE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Avanish Saklani 
Designation  Professor and Colorectal Surgeon 
Affiliation  Tata memorial hospital dr ernest Borges marg parel Mumbai 
Address  Department of Surgical Oncology tata memorial hospital dr ernest Borges marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  7400319886  
Fax    
Email  asaklani@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Avanish Saklani 
Designation  Professor and Colorectal Surgeon 
Affiliation  Tata memorial hospital dr ernest Borges marg parel Mumbai 
Address  Department of Surgical Oncology tata memorial hospital dr ernest Borges marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  7400319886  
Fax    
Email  asaklani@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Avanish Saklani 
Designation  Professor and Colorectal Surgeon 
Affiliation  Tata memorial hospital dr ernest Borges marg parel Mumbai 
Address  Department of Surgical Oncology tata memorial hospital dr ernest Borges marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  7400319886  
Fax    
Email  asaklani@hotmail.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  Surgical Outcomes Research Centre (SOuRCe) at the Royal Prince Alfred Hospital. 
Address  Royal Prince Alfred Hospital, Level 9, Building, 89 Missenden Rd, Camperdown NSW 2050, Australia 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
Brazil
India
Japan
Netherlands
New Zealand
Norway
Sweden
Thailand
United Kingdom
United States of America  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Avanish Saklani  Tata Memorial Hospital  Division of Colorectal services, Department of surgical oncology,Homi Bhabha Building 12th floor,Room No.1212,Tata Memorial Hospital,Dr.ernest borges street parel,Mumbai and ACTREC Kharghar Navi Mumbai Ext.7176
Mumbai
MAHARASHTRA 		 7400319886
91-22-24146937
asaklani@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata memorial center Institutional Ethics Committee I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K628||Other specified diseases of anus and rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  •Locally advanced primary or locally recurrent adenocarcinoma of the rectum
•Total PE (complete en bloc resection of the anus, rectum, genitourinary viscera, reproductive internal organs, regional lymph nodes, and peritoneum)
 
 
ExclusionCriteria 
Details  •Minimally invasive procedures
•Synchronous metastases
•Palliative intent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Perioperative
1)Duration of surgery (minutes)
2)Estimated blood loss (mL)
3)Total length of hospital stay (days)

Morbidity and Mortality
1)Comprehensive Complication Index, measured at discharge
2)Return to the operating theatre
3)Mortality, measured at 30 days

Oncological
1)R0 resection 		 30 Days 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="763"
Sample Size from India="70" 
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)   12/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/07/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
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 - NO
Brief Summary   Pelvic exenteration (PE) is now widely considered the standard of care for appropriately selected patients presenting with locally advanced or recurrent rectal cancer . Due to the encouraging oncological and quality of life outcomes reported for these patients in recent decades, there has been increasing interest in PE globally and a corresponding increase in the number of colorectal surgeons and specialist centres offering exenterative surgery. Such radical surgery is, however, associated with substantial morbidity , functional consequences and at least a temporary reduction in quality of life , and is therefore only justified by the reasonable chance of cure, for which R0 resection margins have been consistently identified as the most important predictor . Several recent comparative studies have demonstrated substantial variability in outcomes of PE between centres, particularly with respect to rates of R0 resection .

Benchmarking is a well established concept in economics, where it is a concept commonly applied to quality improvement. More recently benchmarking has been used to assess surgical performance in complex abdominal surgery . In this context, benchmarking involves identifying a procedure of interest and comparing the outcomes of that procedure at a particular centre to the best possible outcomes (the benchmark) . The difference between a centre’s outcome and the benchmark is a measure of the potential for improvement. This study aims to identify the international benchmark thresholds for pelvic exenteration for locally advanced primary and recurrent rectal cancer, i.e. the best possible outcomes achievable at experienced, specialists centres. This will allow centres (particularly those early in their learning curve) to continuously compare their performance to defined international benchmarks and identify areas for potential improvement.

 
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