| 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
|
|
|
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
|
|
|
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. |