跳至主要内容
临床试验/CTRI/2025/07/091474
CTRI/2025/07/091474尚未招募4 期

To compare Post operative outcomes of Single drain versus Double drain placement in Modified Radical Mastectomy,a Randomized Controlled Trail

DEPARTMENT OF GENERAL SURGERY AIIMS GORAKHPUR1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年8月8日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Comparison of postoperative Seroma formation in Single drain placement vs Double drain placement in Modified Radical Mastectomy patients.

研究概览

简要总结

Breast cancer is the most common malignancy worldwide and a leading cause of cancer related death among women. Modified Radical Mastectomy remains a cornerstone of surgical management, but postoperative complications such as seroma formation remain a significant concern. Seroma, the most frequent complication following mastectomy, occurs in 3 to 85 percent of cases and can result in flap necrosis, infection, and wound dehiscence. The use of closed suction drains is a common strategy to reduce seroma formation, but there is ongoing debate regarding the optimal number of drains.

The study will be conducted at the Department of General Surgery, All India Institute of Medical Sciences, Gorakhpur Uttar Pradesh India. This tertiary care centre is equipped with advanced medical facilities and a high volume of surgical cases, providing a suitable environment for conducting a randomized controlled trial. The setting ensures access to a diverse patient population undergoing Modified Radical Mastectomy, allowing for robust data collection and analysis. This study is a prospective, randomized, controlled, single blinded, parallel assignment, single centre trial designed to compare post operative outcomes of single drain versus double drain placement in patients undergoing Modified Radical Mastectomy. A patient who will fulfil the inclusion criteria and does not satisfy any of the exclusion criteria will be randomized into two groups. Group A (Single Drain Group)  single drain will be placed beneath the mastectomy flap and coming out through axilla. Group B (Double Drain Group) Two drains will be placed one in the axilla and the other beneath the mastectomy flap. All patients will have a 16 French  negative suction drain placed intraoperatively. The drain output will be measured and recorded daily. Drains will be removed once the daily output falls below 10 ml.All patients will receive the same postoperative care, including antibiotics and other medications, to minimize treatment variability. Statistical analysis will be performed to assess differences in outcomes between the two groups. The study evaluates outcomes including incidence of seroma, Pain, Flap necrosis, Wound Gaping and Lymphedema will be accessed in post operative period on Day 1, Day 3, Day 7, Day 10, day 15 and Day 30. The results of this study will provide evidence to Rationalize the use of Single Drain or Double drain and guide best practices, improve patient outcomes, and optimize healthcare resource utilization in Modified Radical Mastectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All operable cases of Carcinoma Breast who will undergo Modified Radical Mastectomy.

排除标准

  • Patient who Refused To give Consent for The Study.

结局指标

主要结局

Comparison of postoperative Seroma formation in Single drain placement vs Double drain placement in Modified Radical Mastectomy patients.

时间窗: Primary outcomes will be assessed post operatively after completion of surgery on Day 1, Day 3, Day 7, Day 10, day 15 and Day 30.

次要结局

  • To compare postoperative(1. Pain)

研究者

发起方
DEPARTMENT OF GENERAL SURGERY AIIMS GORAKHPUR
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Vikas Prasad

All India Institute of Medical Sciences Gorakhpur

研究点 (1)

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