FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 


 
Close