| CTRI Number |
CTRI/2024/11/077411 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Non randomized open clinical trial |
| Study Design |
Other |
|
Public Title of Study
|
comparision ofTranexamic Acid Versus Botropase in Reducing postoperative Bleeding And seroma Formation after Modified Radical Mastectomy |
|
Scientific Title of Study
|
A Comparative Study Of Using Tranexamic Acid Versus Botropase Reducing postoperative Bleeding And seroma Formation Following Modified Radical Mastectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhargav Medagani |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Department of General Surgery, 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
9949810831 |
| Fax |
|
| Email |
medagani.23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar Verma |
| Designation |
Professor and HOD, Department of General Syrgery |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Department of General Surgery, 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
9412164832 |
| Fax |
|
| Email |
docpkverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Kumar Verma |
| Designation |
Professor and HOD, Department of General Syrgery |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Department of General Surgery, 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand
UTTARANCHAL
263139
India |
| Phone |
9412164832 |
| Fax |
|
| Email |
docpkverma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Medagani Bhargav
Department of General Surgery, 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand 263139 |
|
|
Primary Sponsor
|
| Name |
Dr Medagani Bhargav |
| Address |
Department of General Surgery, 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand 263139 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Medagani Bhargav |
Dr. Susheela Tiwari Hospital, Haldwani |
Department of General Surgery, 2nd Floor, Dr. Susheela Tiwari Hospital, Haldwani, Nainital
Nainital
UTTARANCHAL |
9949810831
medagani.23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, GMC, Haldwani |
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 |
Inj. Botropase |
Breast cancer patients who are operated in other units in the department will receive Inj.botropase 2ml
intravenously at the time of induction of anesthesia and followed by 2 ml intra venously 12 hourly for 5
days and will be labelled as group B. |
| Intervention |
Tranexamic acid |
The patients who meet the inclusion criteria will be included in the study and will receive
Inj.Tranexamic acid first dose (1gm IV in 100ml Normal Saline) initially at the the time of induction of
anesthesia, followed by inj tranexamic acid 500mg 8 hourly for 5 days from postoperative day1. These
patients will be labelled as Group A and will be operated in the same unit in the surgery department |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Patients giving informed consent.
Female patients with operable breast cancer undergoing modified radical mastectomy of age more
than 18 year. |
|
| ExclusionCriteria |
| Details |
• Advanced breast cancer patients in which upfront surgery is not indicated.
• Known thrombotic disease or high risk of thromboembolism.
• Patients on anticoagulants.
• Denial of consent.
• Pregnant females.
• Patients deemed unfit for surgery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of tranexamic acid and botropase in reduction of
postoperative bleeding and seroma formation in post Modified radical Mastectomy
patients |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce
Postoperative wound healing time.
Postoperative hospital stay.
Postoperative surgical site infections. |
2 weeks |
|
|
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)
|
17/12/2024 |
| 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="1"
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
|
The patients who meet the inclusion criteria will be included in the study and will receive Inj.Tranexamic acid first dose (1gm IV in 100ml Normal Saline) initially at the the time of induction of anesthesia, followed by oral tab Tranexamic acid 500mg 8 hourly for 5 days from POD1. These patients will be labelled as Group A and will be operated in the same unit in the surgery department. Breast cancer patients who are operated in other units in the department will receive Inj.botropase 2ml intravenously at the time of induction of anesthesia and followed by 2 ml intra venously 12 hourly for 5 days and will be labelled as group B. Demographic data and following data will be collected and will be analysed for the following parameters. 1 Post operative bleeding-will be measured clinically through drain placed intraoperatively or by USG guidance if needed. 2 Seroma formation- will be measured clinically through the intraoperative drain and through USG if needed. 3 Postoperative wound healing time-will be calculated from POD 1 and we will count the number of days the wound takes to heal completely and it will be assessed clinically. 4 Postoperative hospital stay- we will count the number of days the patient takes to get discharged. 5 Post operative wound infection – wound infection will be assessed by clinical symptoms like fever, pain, discharge and signs like erythema, local rise of temperature, tenderness and discharge from the wound. 6 Demography and spectrum of patients |