| CTRI Number |
CTRI/2025/07/092069 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To assess the effectiveness of COLCHICINE in reducing inflammation after major oncological surgeries |
|
Scientific Title of Study
|
Effect of Colchicine as premedication on perioperative inflammatory
response in relation to IL6 and CRP levels in major elective oncological
surgeries: a pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prerna Bhola |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical College |
| Address |
Room no.3026, 3rd floor, OT complex, ESIC Medical College Hospital, Sanathnagar, Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9440152961 |
| Fax |
|
| Email |
dr.prernabhola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R. Gopinath |
| Designation |
Professor |
| Affiliation |
ESIC Medical College |
| Address |
Room no.3021, 3rd floor, OT complex, ESIC Medical College Hospital, Sanathnagar, Hyderabad
TELANGANA
500038
India |
| Phone |
9848024306 |
| Fax |
|
| Email |
gopi59@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prerna Bhola |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical College |
| Address |
Room no.3026, 3rd floor, OT complex, ESIC Medical College Hospital, Sanathnagar, Hyderabad
TELANGANA
500038
India |
| Phone |
9440152961 |
| Fax |
|
| Email |
dr.prernabhola@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital, sanathnagar, hyderabad, telangana, india- 500038 |
|
|
Primary Sponsor
|
| Name |
ESIC medical college |
| Address |
sanathnagar, hyderabad, telangana, india- 500038 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| prerna bhola |
ESIC Medical College Hospital |
anaesthesia department, 3rd floor, OT Complex, ESIC Medical college hospital, Sanathnagar, hyderabad- 500038
Hyderabad
TELANGANA |
9440152961
dr.prernabhola@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, ESIC Medical College and Hospital and superspeciality hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
placebo sugar pills |
single dose of placebo pill will be given orally to the oncosurgery patient 2 hours prior to surgery and samples taken for IL6 and CRP levels before shifting the patient to OT and on postoperative day 1. |
| Intervention |
tablet colchicine 1.2 mg |
single dose of colchicine 1.2 mg will be given orally to the oncosurgery patient 2 hours prior to surgery and samples taken for IL6 and CRP levels before shifting the patient to OT and on the postoperative day 1.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
major elective gastrointestinal or gynaecological
tumour resection in ASA I and II patients of both sexes. |
|
| ExclusionCriteria |
| Details |
age less than 18 years, patients unable to give consent, patients posted for any emergency surgery, patients with renal or hepatic impairment, patients with history of allergy to colchicine and patients with immunosuppressive illness other than neoplasm will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the preoperative with postoperative values of IL6 and CRP levels to know the effectiveness of colchicine as anti-inflammatory agent in oncological surgery patients to be considered as part of ERAS model. |
preoperatively at 9 am on morning of surgery and at 9 am on morning of postoperative day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
In the present pilot study, we wish to evaluate the efficacy of administration of colchicine as premedication in suppressing the postoperative inflammatory response in terms of IL6 and CRP levels on the first postoperative day such that it can be incorporated in the protocol for Early Recovery After Surgery to improve patient outcomes. Primary pilot objective will be to compare the levels of inflammatory markers namely IL6 and CRP preoperatively and postoperatively after administering single dose of 1.2 mg oral colchicine on the morning of planned surgery. This pilot study can also serve as the foundation for a larger multicentre trial. |