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
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"
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.