A study of complications in using harmonic scalpel versus electrocautery in post modified radical mastectomy – A randomized controlled trial

After the clearance from the IRC & IEC, all the eligible patients fulfilling inclusion criteria will be admitted through outpatient department (OPD) with informed consent, on completing full workup for surgery and anesthetic fitness. Diagnosis will be confirmed by FNAC or Trucut biopsy. Patients will be divided into two groups (A & B). Group A – Surgery to be done with harmonic scalpel. Group B – Surgery to be done with electrocautery. Randomization will be performed by group allocation concealment method (i.e) Patient will be divided randomly into two groups by single blinding technique as the investigator knows which patient is alotted in which group. Both the groups will undergo standard modified radical mastectomy with lymph node dissection up to level II. Operating time in minutes from skin incision to closure was recorded. Blood loss during the surgery was estimated by weighing the dry sponges preoperatively and subtracting the weight from the weight of postoperative used sponges (using a digital weighing scale with each gram taken as equal to one millilitre of blood). Suction was not used in the surgery. The amount of blood loss was calculated as mL. Negative pressure closed suction drains will be kept in both the groups, with one tube along the lower skin flap and another tube in axilla. In post-operative period, quantity of drain will be noted every 24hr for both groups. Postoperatively our criteria for drain removal will be when drain quantity in the last 24 hours had fallen to <30ml. Development of seroma as a complication will be defined when drain quantity continued to be >40ml after postoperative day 7 or if there is clinically evident fluid collection beneath the skin flap during follow-up of patients after discharge from hospital. After removal of drain, we will follow-up for the next 12 weeks, skin flaps will be examined regularly to see any fluid collection noticing fluctuation, flap necrosis and seroma will be confirmed with aspiration of fluid. Postoperatively, wound-related pain was assessed using visual analogue scales (VAS) scored on each postoperative morning till Postoperative Day (POD) 7. Clinical assessment of the wound was done on each postoperative morning for flap necrosis and surgical site infection (SSI) till the patient was discharged and on the first follow-up visit to the hospital. All patients will be followed up on weekly basis and during each post-operative visit, the presence of seroma and flap necrosis will be assessed clinically, and the number of aspirations required for the seroma will also documented. Comparison of proportion of group A and group B will be done. Frequency and percentage will be generated for qualitative variables such as seroma formation and flap necrosis