comparing the differences after using monopolar electrocautery or harmonic scalpel in patients of breast cancer
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2021/11/037892
- Lead Sponsor
- Harsh Tiku
- Brief Summary
It is a Randomizedprospective 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 50
1.Diagnosed pre operative cases of breast cancer.
1.Inflammatory breast carcinoma 2.Those who have received neoadjuvant radio/chemotherapy 3.Metastatic carcinoma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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.
Trial Locations
- Locations (1)
GOVT MEDICAL COLLEGE AND HOSPITAL
🇮🇳Chandigarh, CHANDIGARH, India
GOVT MEDICAL COLLEGE AND HOSPITAL🇮🇳Chandigarh, CHANDIGARH, IndiaDR HARSH TIKUPrincipal investigator9814601192harshtiku312@gmail.com