A RANDOMISED CONTROL STUDY COMPARING THE PLACEMENT OF 2 DRAINS, THAT IS, IN AXILLA AND PECTORAL SKIN FLAP VERSUS SINGLE DRAIN IN AXILLA POST MODIFIED RADICAL MASTECTOMY IN PREVENTING POST OPERATIVE SEROMA AND LOCAL COMPLOCATIONS

Phase 2

Not yet recruiting

Conditions: Malignant neoplasms of breast,

Registration Number: CTRI/2023/02/049897

Lead Sponsor: DR DEEPALI SHETTY

Brief Summary: Breast cancer has seen a rapid rise inincidence, becoming the leading cause of global cancer incidence in 2020.Choice of treatment is Modified Radical Mastectomy (MRM). Most commonlyencountered complication of MRM is formation of seroma, which can be preventedby the use of closed suction drainage system, preferable active suctiondrainage.

ThisProspective Randomised controlled study attempts to compare the efficacy andthe morbidities associated with use of combined axillary and pectoral drainversus single axillary drainage post modified radical mastectomy.

Objectives:Assessing the incidence of seroma formation, post op wound infection, durationof drain insitu, drain output and length of hospital stay

Womenwith histologically proven breast cancer, stage 1,2 3 not undergoingneoadjuvant therapy undergoing MRM, will be included in the study and will berandomized into 2 groups using envelope method, Group A (single axillary drain)and Group B (combined axillary and pectoral drainage), with 78 patients in eachgroup (total sample size 156)

Standardizedoperative procedure and post-operative course will be followed in all patientsin both groups in drain emptying and dressing

Patient will be followed up postoperativelyto evaluate drain output, incidence of surgical site infection, flap necrosis,seroma formation (clinically and quantified with ultrasonography), timing ofdrain removal and total duration of hospital stay.

Data willcollected and analyzed with SPSS version 28.

The quantitative data will be reported as meanand standard deviation. Differences between means will be tested with Studentâ€™st-test and the incidence of seroma, flap necrosis and wound infection will bereported as number and percentages and Fisherâ€™s exact test/ Chi square testwill be employed.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 156

Inclusion Criteria

Histologically proven Breast cancer patients of Stage 1 and II undergoing Modified Radical Mastectomy Stage III breast cancer not receiving neo-adjuvant treatment undergoing Modified Radical Mastectomy.

Exclusion Criteria

Recurrent breast cancer Patients receiving Neoadjuvant chemotherapy or Radiotherapy Metastatic breast cancer.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess occurrence of post-operative seroma with use of single versus double drainage in modified radical mastectomy, in patients with histologically proven breast cancer not undergoing neoadjuvant therapy	1ST, 3RD, 5TH, 7TH, 9TH DAY POST OPERATIVELY

Secondary Outcome Measures

Name	Time	Method
Post-operative pain	Occurrence of Flap necrosis

Trial Locations

Locations (1): AIIMS NAGPUR
🇮🇳
Nagpur, MAHARASHTRA, India
AIIMS NAGPUR
🇮🇳Nagpur, MAHARASHTRA, India
DR DEEPALI J SHETTY
Principal investigator
9008811623
djshetty97@gmail.com