CTRI Number |
CTRI/2021/11/037892 [Registered on: 10/11/2021] Trial Registered Prospectively |
Last Modified On: |
08/11/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
comparing the differences after using monopolar electrocautery or harmonic scalpel in patients of breast cancer |
Scientific Title of Study
|
Comparing post-operative outcome for patients undergoing modified radical mastectomy for carcinoma breast using monopolar electrocautery versus harmonic scalpel |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Harsh Tiku |
Designation |
Post Graduate Junior Resident |
Affiliation |
GOVT MEDICAL COLLEGE AND HOSPITAL |
Address |
SURGERY OFFICE BLOCK D LEVEL 3, GOVT MEDICAL COLLEGE AND HOSPITAL, CHANDIGARH
Chandigarh CHANDIGARH 160030 India |
Phone |
9814601192 |
Fax |
|
Email |
harshtiku312@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Rajeev Sharma |
Designation |
Professor |
Affiliation |
Governemnet medical college and hospital, sector 32, Chandigarh |
Address |
SURGERY OFFICE BLOCK D LEVEL 3, GOVT MEDICAL COLLEGE AND HOSPITAL, CHANDIGARH
Chandigarh CHANDIGARH 160030 India |
Phone |
9646121562 |
Fax |
|
Email |
rjvsharma63@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Harsh Tiku |
Designation |
Post Graduate Junior Resident |
Affiliation |
Governemnet medical college and hospital, sector 32, Chandigarh |
Address |
SURGERY OFFICE BLOCK D LEVEL 3, GOVT MEDICAL COLLEGE AND HOSPITAL, CHANDIGARH
Chandigarh CHANDIGARH 160030 India |
Phone |
9814601192 |
Fax |
|
Email |
harshtiku312@gmail.com |
|
Source of Monetary or Material Support
|
Government medical college and hospital, Chandigarh |
|
Primary Sponsor
|
Name |
Harsh Tiku |
Address |
GOVT MEDICAL COLLEGE AND HOSPITAL, SECTOR 32 CHANDIGARH |
Type of Sponsor |
Other [] |
|
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 HARSH TIKU |
GOVT MEDICAL COLLEGE AND HOSPITAL |
SURGERY OFFICE, D BLOCK LEVEL 3, GOVT MEDICAL COLLEGE AND HOSPITAL, SECTOR 32 CHANDIGARH Chandigarh CHANDIGARH |
9814601192
harshtiku312@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL CORE COMMITTEE GMCH CHD |
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 |
Intervention |
MODIFIED RADICAL MASTECTOMY |
BY COMPARING POST OPERATIVE OUTCOMES USING MONOPOLAR ELECTROCAUTERY AND HARMONIC SCALPEL IN MODIFIED RADICAL MASTECTOMY FOR 28 DAYS POST SURGERY |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
1. Diagnosed pre operative cases of breast cancer. |
|
ExclusionCriteria |
Details |
1. Inflammatory breast carcinoma
2. Those who have received neoadjuvant
radio/chemotherapy
3. Metastatic carcinoma
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1.To compare post operative seroma formation/total drain output in patients undergoing surgery for breast cancer using monopolar electrocautery versus harmonic scalpel. |
from admission to 30 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To compare post operative pain in patients undergoing surgery for breast cancer using monopolar electrocautery versus harmonic scalpel.
2. To compare post operative complication of flap necrosis in patients undergoing surgery for breast cancer using monopolar electrocautery versus harmonic scalpel.
3. To compare intraoperative duration.
|
From admission to 30 days |
|
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)
|
10/11/2021 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
10/11/2021 |
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) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
It is a Randomized prospective interventional study. the study will be conducted in the Department of Surgery at Govt. Medical College & Hospital, Chandigarh, after approval from the institutional ethics committee. Patients will be enrolled only after taking written and informed consent.
Inclusion Criteria: 1. Diagnosed preoperative cases of breast cancer. Exclusion Criteria: 1. Inflammatory breast carcinoma 2. Those who have received neoadjuvant radio/chemotherapy 3. Metastatic carcinoma The study will be conducted for a period of 18 months. All patients with carcinoma breast reporting in GMCH, Chandigarh for treatment will be screened for the study. A minimum of 50 cases of malignant breast lesions will be enrolled. All the selected/enrolled patients will be investigated on the basis of a triple assessment. A thorough history, as well as a clinical examination, will be done. Routine investigations like complete haemogram, coagulogram, serum electrolytes, renal and liver function tests, electrocardiogram and chest X-ray will be done. Specific Radiological examination like Sonomammography and/or X-ray mammography will be done. Magnetic resonance mammography (MRI)/ computed tomography (CT)/positron emission tomography (PET) scan will be done as and when required. FNAC/ Tru cut biopsy for tissue diagnosis will also be done. All the patients meeting the inclusion criteria and consenting for the study will be finally selected. The patients will be divided into the Harmonic Scalpel group and Electrocautery group randomly by the lottery method. The time to be noted from skin incision to raising of the flaps during modified radical mastectomy. · The patients will be followed postoperatively for a period of one month. Postoperative pain, drain output and flap necrosis will be checked for a period of one month. · Post operative pain will be assessed daily till the discharge of the patient using VAS score. · The daily drain output will be noted. · The drain will be removed when the drain output is less than 30mL/ 24 hours. · local complications like seroma formation and flap necrosis will be noted. · The uncomplicated patients will be discharged on postoperative day 7. · The patients will be followed up weekly till 1 month with daily drain outputs and complications, if present · Drains, if present, will be removed during follow up if the daily drain output is less than 30mL for at least 3 consecutive days. · The total drain output will be noted on the removal of the drain along with the day of drain removal. · The total drain output, post-operative pain, postoperative complications, days for which the drain is kept will be compared for the two groups. |