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临床试验/CTRI/2023/02/049897
CTRI/2023/02/049897尚未招募2 期

A prospective randomized controlled study to compare the efficacy of combined Axillary and Pectoral drainage versus Sole Axillary drainage in Modified Radical Mastectomy

DR DEEPALI SHETTY1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2023年2月25日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
156
试验地点
1
主要终点
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

研究概览

简要总结

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 Student’st-test and the incidence of seroma, flap necrosis and wound infection will bereported as number and percentages and Fisher’s exact test/ Chi square testwill be employed.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
Female

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

时间窗: 1ST, 3RD, 5TH, 7TH, 9TH DAY POST OPERATIVELY

次要结局

  • Post-operative pain(Occurrence of Flap necrosis)

研究者

发起方
DR DEEPALI SHETTY
申办方类型
Other [self]

研究点 (1)

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