| CTRI Number |
CTRI/2018/04/013162 [Registered on: 11/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
The role of serum interleukin-6 level in predicting the postoperative complications after ovarian cancer surgery |
|
Scientific Title of Study
|
Serum interleukin-6 (IL-6) levels in prognosticating postoperative complications after ovarian cancer surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vibhavari Naik |
| Designation |
Senior Consultant Anaesthesiologist and Intensivist |
| Affiliation |
Basavatarakam Indo-American Cancer Hospital and Research Institute |
| Address |
Department of Anaesthesiology Basavatarakam Indo-American Cancer Hospital and Research Institute Block 1 4th floor Road no 10 Banjara hills Hyderabad Telangana
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
|
| Fax |
|
| Email |
vibnaik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vibhavari Naik |
| Designation |
Senior Consultant Anaesthesiologist and Intensivist |
| Affiliation |
Basavatarakam Indo-American Cancer Hospital and Research Institute |
| Address |
Department of Anaesthesiology, Basavatarakam Indo-American Cancer Hospital and Research Institute Block 1 4th floor Road no 10 Banjara hills Hyderabad Telangana
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
|
| Fax |
|
| Email |
vibnaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vibhavari Naik |
| Designation |
Senior Consultant Anaesthesiologist and Intensivist |
| Affiliation |
Basavatarakam Indo-American Cancer Hospital and Research Institute |
| Address |
Department of Anaesthesiology Basavatarakam Indo-American Cancer Hospital and Research Institute Block 1 4th floor Road no 10 Banjara hills Hyderabad Telangana
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
|
| Fax |
|
| Email |
vibnaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rosche Diagnostics GmbH Sandhoferstrasse 116D - 68305 Mannheim Germany |
|
|
Primary Sponsor
|
| Name |
Dr Vibhavari Naik |
| Address |
Department of Anaesthesilogy
Basavatarakam Indo-American Cancer Hospital and Research Centre
Hyderabad |
| Type of Sponsor |
Other [Principal investigator] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr D Radharani |
HOD Microbiology
Basavatarakam Indo-American Cancer Hospital and Research Centre |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vibhavari Naik |
Basavatarakam Indo-American Cancer Hospital and Research Institute |
Department of Anaesthesiology Block 1 4th floor Road no 10
Banjara Hills
Hyderabad
Hyderabad
ANDHRA PRADESH |
9959189958
vibnaik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Basavatarakam Indo-American Cancer Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
carcinoma ovary, (1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
All Carcinoma Ovary patients posted for ovarian cytoreduction surgery will be included |
|
| ExclusionCriteria |
| Details |
Patients posted for emergency procedures will be excluded
Patients who refuse to consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mortality
Complications |
During hospital stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Length of ICU stay
Length of Hospital stay |
During hospital stay |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
27/02/2017 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Interleukin-6 (IL-6) is an acute phase cytokine, with a pro-inflammatory character. Raised serum IL-6 levels have been associated with acute and chronic inflammatory conditions including cancer. An elevated serum IL-6 level has been associated with an adverse prognosis in patients with different types of cancers, including ovarian cancer. Ovarian cancer surgery has shown to be associated with a high risk (up to 34%) of 30-day postoperative morbidity. This can significantly affect the hospital stay, costs and the psychological well-being of the patient. There are no studies evaluating the changes in the serum levels of IL-6 postoperatively in ovarian cancer surgery, and its relation to postoperative complications. Our objectives are - 1.To determine if the serum level of interleukin-6 (IL-6) was elevated pre-operatively in patients with ovarian cancer in our patient population.
2.To determine if high serum levels of IL-6 post-operatively can predict increased postoperative morbidity due to postoperative complications. We hypothesize that rise in serum IL-6 levels postoperatively, can help to prognosticate postoperative complications after ovarian cytoreductive surgery. |