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CTRI Number  CTRI/2024/08/072057 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Snap shot study 
Study Design  Single Arm Study 
Public Title of Study   RAVISRO Study - Postoperative Outcomes of Radical Visceral resections in Oncosurgery 
Scientific Title of Study   Postoperative outcomes of oncology patients undergoing radical visceral resections - a multi-centric observational study (RaVisRO study). 
Trial Acronym  RAVISRO 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepa Chandramohan 
Designation  Senior Consultant and Head  
Affiliation  MVR Cancer Centre and Research Institute 
Address  Department of Critical Care Medicine MVR Cancer Centre and Research institute Kozhikode

Kozhikode
KERALA
673601
India 
Phone  7012035765  
Fax    
Email  drdeepac@mvrccri.co  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepa Chandramohan 
Designation  Senior Consultant and Head  
Affiliation  MVR Cancer Centre and Research Institute 
Address  Department of Critical Care Medicine MVR Cancer Centre and Research institute Kozhikode

Kozhikode
KERALA
673601
India 
Phone  7012035765  
Fax    
Email  drdeepac@mvrccri.co  
 
Details of Contact Person
Public Query
 
Name  Dr Deepa Chandramohan 
Designation  Senior Consultant and Head  
Affiliation  MVR Cancer Centre and Research Institute 
Address  Department of Critical Care Medicine MVR Cancer Centre and Research institute Kozhikode

Kozhikode
KERALA
673601
India 
Phone  7012035765  
Fax    
Email  drdeepac@mvrccri.co  
 
Source of Monetary or Material Support  
MVR Cancer Centre and Research Institute Kozhikode  
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 18  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rakesh Garg  AIIMS New Delhi  Department of Oncoanesthesia and Palliative Medicine, Ansari Nagar, New Delhi 110029
New Delhi
DELHI 
9810394950

drrgarg@hotmail.com 
Dr Lakshmi Kumar  Amrita Institute of Medical Sciences and Research Centre  Department of Anesthesiology and Critical Care, Ponekkara Rd, Edappally, Kochi, Ernakulam, Kerala 682041
Ernakulam
KERALA 
9496211333

Lakshmi.k.238@gmail.com 
Dr Kapil Raj  Apollo Cancer Centre  Department of Surgical Oncology, No 320, Anna Salai, Teynampet, Nandanam, Chennai 600 035
Chennai
TAMIL NADU 
9840414398

kapilcdm@gmail.com 
Dr Vibhavari Naik  Basavatarakam Indo-American Cancer Hospital and Research Institute  Department of Anesthesiology, Road No 10, Banjara Hills, Hyderabad, Telangana 500034
Hyderabad
TELANGANA 
9959189958

vibnaik@gmail.com 
Dr Ritesh Tapkire  Cachar cancer hospital and research centre   Department of Surgical Oncology, CCHRC, Silchar, Assam 788015
Cachar
ASSAM 
7002053437

ritesh.tapkire@cacharcancerhospital.org 
Dr Sunil Kumar  HCG Cancer Hospital  Department of Anaesthesiology and Critical Care, No 8, HCG Towers, P Kalinga Rao Rd, Sampangiram Nagar, Bengaluru, Karnataka 560027
Bangalore
KARNATAKA 
9241271214

drsunilkumar.r@hcgel.com 
Dr Snita Sinukumar  Jehangir Hospital  Department of Surgical oncology, 32, Sassoon Road, Pune 411001
Pune
MAHARASHTRA 
9619649377

snitanag@gmail.com 
Dr Shashidhar GS  Kidwai Memorial Institute of Oncology  Department of Anesthesiology, Hosur Road, Bangalore 560029
Bangalore
KARNATAKA 
9008028611

drshashi_2007@yahoo.co.in 
Dr Sameer Gupta  King George Medical University  Department of Surgical Oncology, Shah Mina Rd, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 
9794361103

sameerdr79@gmail.com 
Dr Jyotirmay Kirtania  Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital  Department of Anesthesiology, Critical Care and Pain Management, BHU Campus, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH 
9330960138

jyotirmay@mpmmcc.tmc.gov.in 
Dr Sivakumar Mahalingam  MGM Cancer Institute and Healthcare   Department of Surgical Oncology, Nelson Manickam Road, Rajeswari St, Rajaram Mehta Nagar, Aminjikarai, Chennai, Tamil Nadu 600029
Chennai
TAMIL NADU 
9840365402

itzdrsiva@gmail.com 
Dr Deepa Chandramohan  MVR Cancer Centre and Research Institute  Department of Critical care medicine, Room No 1305, MVRCCRI, Vellalassery, Kozhikode -673601
Kozhikode
KERALA 
7012035765

drdeepac@mvrccri.co 
Dr Indira Gurajala  Nizams Institute of Medical Sciences  Department of Anesthesiology, NIMS, Hyderabad, Telangana 500082
Hyderabad
TELANGANA 
7729932044

indiradevraj@yahoo.co.in 
Dr NK Vinod  Sri Shankara Cancer Hospital and Research Centre  Department of Anaesthesiology and Critical Care, 1st cross, Shankarapuram, Basavanagudi, Bangalore 560004
Bangalore
KARNATAKA 
9980761214

nkvinod@hotmail.com 
Dr Sudipta Mukherjee  Tata Medical Center Kolkata  Department of Critical Care Medicine, 14 MAR EW, New Town, Rajarhat, Kolkata, West Bengal 700 160
Kolkata
WEST BENGAL 
8697688050

sudiptanrs@gmail.com 
Dr Malini Joshi  Tata Memorial Centre Advanced Centre for Treatment, Research and Education in Cancer   Department of Anesthesiology and Critical Care, Plot No 1 and 2, Sector 22, Kharghar, Navi Mumbai 410210
Mumbai
MAHARASHTRA 
9987226657

jmalini2007@rediffmail.com 
Dr Sohan Solanki  Tata Memorial Hospital Mumbai  Department of Anaesthesiology and Critical Care, Dr E Borges Road, Parel, Mumbai 400 012
Mumbai
MAHARASHTRA 
9869253201

sohansolanki@gmail.com 
Dr Aruna Prabhu  Thangam Cancer Center   Department of Surgical Oncology, 54, Dr Sankaran Road, Trichy Main Rd, Namakkal, Tamil Nadu 637001
Namakkal
TAMIL NADU 
9870221368

dranuprabhu.surgeon@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
IEC MVR Cancer Centre and Research Institute Calicut  Approved 
IEC of AIMS Kochi  Approved 
IEC of BIACHRI Hyderabad  Approved 
IEC of Jehangir Hospital  Approved 
IEC of MGM Cancer Institute and Healthcare  Approved 
IEC of MPMMCC and HBCH Varanasi  Approved 
IEC of NIMS Hyderabad  Approved 
IEC of Sri Shankara Cancer Foundation and Sri Shankara Cancer Hospital and Research Centre  Approved 
IEC of Tata Medical Center Kolkata  Approved 
IEC of TMH Mumbai  Approved 
IEC TMC ACTREC  Approved 
Thangam Hospital IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C260||Malignant neoplasm of intestinal tract, part unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients aged 18 years and above who are undergoing elective onco-surgical procedures that involve radical visceral resections and are shifted postoperatively to the surgical ICU.
1) Cytoreductive surgery (CRS) plus Hyperthermic Intraperitoneal Chemotherapy
(HIPEC)
2) Transthoracic esophagectomy (TTE) plus 3-field lymph node dissection
3) Hepatectomy
4) Parenchyma-sparing liver metastatectomy
5) Radical cholecystectomy
6) Extrahepatic biliary tree excision
7) Whipple’s procedure with or without vascular reconstruction
8) Retroperitoneal sarcoma excision
9) Pelvic exenteration surgery 
 
ExclusionCriteria 
Details  Redo surgeries that involve radical visceral resections within 30 days of primary surgery will be excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of Clavien-Dindo postoperative complications and the Comprehensive Complication Index (CCI)  at discharge and at 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Morbidity predictors  90 days 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   16/08/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Onco-surgical procedures involving radical visceral resections often pose major challenges to the intensive care physicians and surgeons during the postoperative period. The higher morbidity and mortality rates noted are not only due to the complex nature of these surgical procedures, but also due to the postoperative stormy course that involves major fluid shifts, major blood loss, multiple blood transfusions, dyselectrolytemias, sepsis, anastomotic leaks, major adverse cardiac events, pulmonary complications and re-admission to intensive care unit (ICU). Various factors such as age, body mass index (BMI), American Society of Anesthesiologists (ASA) grade, pre-operative albumin levels, stage of cancer, surgical complexity, frailty status, duration of surgery, intraoperative blood loss, transfusion of blood products and cumulative fluid balance predict the occurrence of postoperative complications. The higher incidence of overall and severe complications (i.e., higher comprehensive complication index or CCI) noted in these patients especially during the immediate postoperative period can lead to increased length of stay (LOS) in the ICU and in the hospital, higher ICU re-admission rate, increased re-intubation rate and higher mortality rates. A thorough knowledge of these morbidity predictors, postoperative complications and outcomes can help in anticipation, prevention, early detection and timely management of these complexities. We, therefore intend to conduct a study to observe the outcomes following oncological surgeries that involve radical visceral resections.
 
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