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CTRI Number  CTRI/2023/11/060042 [Registered on: 20/11/2023] Trial Registered Prospectively
Last Modified On: 04/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective data collection 
Study Design  Other 
Public Title of Study   A study on different surgical procedures for endometrial cancer 
Scientific Title of Study   A Retrospective Multicenter Real-World Evidence Study of Open, Laparoscopic and Robotic-assisted Staging Surgery for Endometrial Cancer 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ISI-dVHM-001, Version 2.0 dated 25th July 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jaydip Bhaumik 
Designation  Senior Consultant and Head, Gynaecological Oncology 
Affiliation  Tata Medical Center 
Address  Department of Gynaecological Oncology, Room No. 105, First Floor, Tata Translational Cancer Research Centre,
Tata Medical Center, 14, Major Arterial Road (EW), New Town, Rajarghat, Kolkata
Kolkata
WEST BENGAL
700160
India 
Phone  03366057000  
Fax    
Email  jaydip.bhaumik@tmckolkata.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Akhil Dahiya 
Designation  Head-Clinical Affairs and Research 
Affiliation  Intuitive Surgical Pvt. Ltd. India 
Address  The Millennia, Tower A, Level 5, No. 1 and 2 Murphy Road, Ulsoor, Bangalore

Bangalore
KARNATAKA
560008
India 
Phone  08045505100  
Fax    
Email  akhil.dahiya@intusurg.com  
 
Details of Contact Person
Public Query
 
Name  Dr Akhil Dahiya 
Designation  Head-Clinical Affairs and Research 
Affiliation  Intuitive Surgical Pvt. Ltd. India 
Address  The Millennia, Tower A, Level 5, No. 1 and 2 Murphy Road, Ulsoor, Bangalore

Bangalore
KARNATAKA
560008
India 
Phone  08045505100  
Fax    
Email  akhil.dahiya@intusurg.com  
 
Source of Monetary or Material Support  
Intuitive Surgical Pvt. Ltd. India 
 
Primary Sponsor  
Name  Intuitive Surgical Pvt. Ltd. India 
Address  The Millennia, Tower A, Level 5, No. 1 and 2 Murphy Road, Ulsoor, Bangalore Karnataka 560008 
Type of Sponsor  Other [Medical Device Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jeewanram Vishnoi  All India Institute of Medical Sciences (AIIMS), Jodhpur  Room No. 509, 5th Floor, A-Block, Department of Surgical Oncology, All India Institute of Medical Sciences (AIIMS), Basni Industrial Area, Phase-2, Jodhpur – 342005
Jodhpur
RAJASTHAN 
02912831001

drjvishnoi@gmail.com 
Dr Priya Bhati  Amrita Institute of Medical Sciences, Kochi  Room No., Department of Gynae Oncology, Amrita Institute of Medical Sciences and Research Centre, Ponekkara P.O., Kochi – 682041
Ernakulam
KERALA 
04842852100

priya.ete@gmail.com 
Dr Priya Kapoor  Apollo Proton Cancer Centre, Chennai  Room No., Department of Surgical Oncology, Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai - 600041
Chennai
TAMIL NADU 
07338992222

dr.priyaskapoor@gmail.com 
Dr Somashekhar S P  Aster CMI Hospitals, Bangalore  Room No. 1, Department of Surgical, Gynaecological Oncology and Robotic Surgery, No. 43/2, New Airport Road, NH 44, Sahakar Nagar, Hebbal, Bengaluru – 560092
Bangalore
KARNATAKA 
08043420100

somashekhar.sp@asterhospital.com 
Dr Ujwala Prakash  Cancer Institute, Adyar, Chennai  Room No., 3rd Floor, Department of Gynaecology Oncology, OPD Building, Cancer Institute (WIA), No: 38, Sardar Patel Road, Adyar, Chennai – 600020
Chennai
TAMIL NADU 
04422209150

drujwalaprakash@gmail.com 
Dr Nidhi Nayyar  Dr. B.L. Kapur Hospital, Delhi  Room No., 1st Floor, Department of Gynaecologic Surgical Oncology and Robotic Surgery, Dr. B. L. Kapur Memorial Hospital, Pusa Road, Rajendra Place, New Delhi – 110005
Central
DELHI 
01130403040

drnidhinayyar@gmail.com 
Dr Swapna Mishra  Fortis Hospitals, Mohali  Room No., Department of Obstetrics and Gynaecology, Fortis Hospital, Sector - 62, Sahibzada Ajit Singh Nagar, Chandigarh – 160062
Chandigarh
CHANDIGARH 
01724692222

swapna.misra73@gmail.com 
Dr Rama Joshi  Fortis Memorial Research Institute, Gurugram, Haryana  Room No., Department of Gynae Oncology and Robotic Surgery, Fortis Memorial Research Institute, Sector - 44, Opposite HUDA City Centre, Gurugram – 122002
Gurgaon
HARYANA 
8860022554

dr.ramajoshi@gmail.com 
Dr Yogesh Kulkarni  Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Mumbai  Room No., Department of Gynaecologic Oncology and Robotic Surgery, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Four Bungalows, Andheri - West, Mumbai – 400053
Mumbai
MAHARASHTRA 
02230937215

yogesh.kulkarni@kokilabenhospitals.com 
Dr Kanika Batra Modi  Max Super Speciality Hospital, Saket, Delhi  Room No., Department of Gynaecological Oncology, East Wing, Max Super Speciality Hospital, 2, Press Enclave Road, Saket, New Delhi – 110017
South
DELHI 
01126515050

kanica.batra@gmail.com 
Dr Rohit Ranade  Mazumdar Shaw Medical Center, Bengaluru  Room No., Ground Floor, Department of Gynaecology Oncology and Robotic Surgery, 258/A, Bommasandra Industrial Area, Hosur Road, Anekal Taluk, Bangalore – 560099
Bangalore
KARNATAKA 
18003090309

rohitraghunath.ranade.dr@narayanahealth.org 
Dr Arunava Roy  Medica Superspecialty Hospital, Kolkata  Room No. 11, Second Floor, Department of Gynecologic Oncology and Women Cancer Initiative, Medica Superspecialty Hospital, 127, Mukundapur, E.M. Bypass, Kolkata – 700099
Kolkata
WEST BENGAL 
03366520000

royarun.net@gmail.com 
Dr Kaustav Basu  Narayana Superspeciality Hospital, Howrah  Room No., Department of Gynaecology Oncology and Robotic Surgery, Narayana Superspeciality Hospital, 120/1, Andul Road, Near Nabanna, Howrah, Kolkata – 711103
Kolkata
WEST BENGAL 
18003090309

dr.kaustavbasu@gmail.com 
Dr Vandana Jain  Rajiv Gandhi Cancer Institute (RGCI), Delhi  Room No., 1st Floor, D-Block, Rajiv Gandhi Cancer Institute and Research Centre, Sector - 5, Rohini, Delhi – 110085
North
DELHI 
01147022222

jain.vandana@rgcirc.org 
Dr Jaydip Bhaumik  Tata Medical Center, Kolkata  Room No. 105, First Floor, Department of Gynaecological Oncology, Tata Translational Cancer Research Centre, Tata Medical Center, 14, Major Arterial Road (EW), New Town, Rajarghat, Kolkata - 700160
Kolkata
WEST BENGAL 
03366057000

jaydip.bhaumik@tmckolkata.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Aster CMI Hospital Institutional Ethics Committee  Approved 
Clinical Research Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Not Applicable 
Institutional Ethics Committee  Not Applicable 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee - Academics  Approved 
Institutional Ethics Committee – Biomedical Research  Approved 
Institutional Ethics Committee, Devki Devi Foundation  Approved 
Institutional Review Board  Approved 
Institutional Review Board  Approved 
Narayan Health Medical Ethics Committee  Approved 
NSH Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C579||Malignant neoplasm of female genital organ, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1. Subject who was 18 years of age or older at the time of surgery
2. Subject who has undergone any of open, laparoscopic and robotic-assisted staging surgery [total hysterectomy with or without any of the following: (a) bilateral salpingo-oophorectomy, (b) peritoneal cytology/lavage, (c) lymph node dissection, (d) adhesiolysis, (e) sentinel lymph node mapping, (f) omentectomy] for Stages I-III endometrial cancer (Stage I-III, as per 8th Edn, 2017 AJCC TNM and FIGO Surgical Staging Systems for Endometrial Cancer)
 
 
ExclusionCriteria 
Details  1. Subject who has undergone any of open, laparoscopic and robotic-assisted endometrial resection for Stage IV endometrial cancer (as per 8th Edn, 2017 AJCC TNM and FIGO Surgical Staging Systems for Endometrial Cancer) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is to retrospectively assess the perioperative outcomes through discharge and the short-term clinical outcomes from discharge to 90 days after open, laparoscopic, or robotic-assisted staging surgery for endometrial cancer  Till discharge, and from discharge to 90 days after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome of this study is to retrospectively assess the oncological outcomes, disease-free survival, and overall survival from postoperative day 91 and beyond up to 5 years after open, laparoscopic, or
robotic-assisted staging surgery for endometrial cancer
 
From postoperative day 91 and beyond, up to 5 years after surgery 
 
Target Sample Size   Total Sample Size="8000"
Sample Size from India="8000" 
Final Enrollment numbers achieved (Total)= "2768"
Final Enrollment numbers achieved (India)="2768" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/11/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

From a treatment standpoint, multidisciplinary, multimodality treatment is indicated for the management of endometrial cancer. For Endometrial cancer cases suitable for surgery (irrespective of stage), Total hysterectomy with Bilateral salpingo-oophorectomy (TH/BSO) with surgical staging is offered. Adjuvant radiation (brachytherapy/EBRT) with/without systemic therapy is offered, depending on patients and disease factors. In patients not suitable for surgery, radiation and/or systemic therapy are offered. Patients are then re-evaluated for surgical resection. While offering surgical treatment to patients with Stages I, II, and III endometrial cancer, the selection of technique (open, laparoscopic, or robotic-assisted) is an important discussion point amongst the surgical team as well as with the patient. Leading guidelines advocate TH/BSO and lymph node assessment may be performed by any surgical route (eg, laparoscopic, robotic, vaginal, abdominal. Although these guidelines recommend a minimally invasive approach as the standard in uterine-confined disease due to a lower rate of surgical site infection, transfusion, venous thromboembolism, decreased hospital stay, and lower cost of care, without compromise in oncologic outcomes. There is a large body of global published literature with respect to the techniques of surgery for endometrial cancer. However, the majority of evidence emanates from the Western world, and there is a paucity of evidence in Indian settings. We could not find any multi-centric study from India for any of these techniques (single arm or multiple cohorts). To fill this gap, there is a need for a multi-centric real-world evidence study from India that can serve as a local benchmark for perioperative, oncological, and functional outcomes for staging surgery for endometrial cancer.

 
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