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CTRI Number  CTRI/2024/11/077338 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 21/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparison of surgical morbidity and cancer outcomes of patient undergoing lymphnode removal manually vs robotic 
Scientific Title of Study   Laparoscopic vs robotic lateral pelvic lymph node dissection in locally advanced rectal cancer: a cohort study comparing peri-operative morbidity and short-term oncological outcomes 
Trial Acronym  NIL 
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 Street, Parel, Mumbai (India) 
Address  Department of Surgical Oncology Tata memorial hospital Dr Ernest Borges Marg Parel Mumbai MAHARASHTRA 400012 India

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 Street, Parel, Mumbai (India) 
Address  Department of Surgical Oncology Tata memorial hospital Dr Ernest Borges Marg Parel Mumbai MAHARASHTRA 400012 India


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 Street, Parel, Mumbai (India) 
Address  Department of Surgical Oncology Tata memorial hospital Dr Ernest Borges Marg Parel Mumbai MAHARASHTRA 400012 India


MAHARASHTRA
400012
India 
Phone  7400319886  
Fax    
Email  asaklani@hotmail.com  
 
Source of Monetary or Material Support  
No funding required for this study as retrospective study Infrastructure support will be provided by study site Tata Memorial hospital Dr Earnest Borges Marg Parel Mumbai 400012,India 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Avanish Saklani  Tata Memorial HospitaI  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
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 Centre Institutional Ethics Committee II  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  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  consecutive patients with non-metastatic, histopathologically-proven rectal adenocarcinoma with significant lateral pelvic lymphadenopathy, undergoing elective curative-intent minimally-invasive (laparoscopic or robotic) TME or extended-TME and LPLND, regardless of the receipt of neoadjuvant therapy during the study period.  
 
ExclusionCriteria 
Details  Patients with a history of having undergone pelvic surgery in the past, histologies other than adenocarcinoma, or presenting with locally-advanced tumors requiring adjacent organ resections or pelvic exenterations. Pateint with incomplete medical records 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
i.Postoperative morbidity
ii.Positive margins (including CRM)
iii.Median LPLN yield (IQR)
iv.LPLN positivity rate
v.Lateral Pelvic Recurrence rate
vi.2-year Event-free Survival
vii.2-year Overall Survival
 		 2 years
 
 
Secondary Outcome  
Outcome  TimePoints 
i.Distribution of complications in the postoperative period.
ii.Length of hospital stay
iii.Intra-operative blood loss
 		 2 years 
 
Target Sample Size   Total Sample Size="115"
Sample Size from India="115" 
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)   11/12/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Robotic surgery has been associated with superior short-term outcomes in patients undergoing total mesorectal excision (TME) for organ-confined rectal cancer. However, whether this approach offers an additional benefit over laparoscopy when performing lateral pelvic lymph node dissection (LPLND) with TME or extended TME in locally-advanced rectal cancer (LARC) with clinically-significant lateral pelvic lymphadenopathy is not known.

 
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