Determine the Efficacy of Closed Suction Drain After Hydrocelectomy in Primary Vaginal Hydrocele: An Open-label Randomised Controlled Trial (END Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Hematoma
研究概览
简要总结
There is no clear consensus regarding the benefits of putting a closed suction drain after eversion of the sac in a hydrocele of the tunica vaginalis testis. Our study will find out the benefits if at all of a closed suction drain in hydrocele surgery. The potential complications expected after hydrocelectomy surgery are bleeding, infection, redness, and pain. There is no such trial to date to determine the benefits of putting a closed suction drain after hydrocelectomy surgery.
详细描述
Study objectives:
- Primary:
To compare the postoperative complication rates of hematoma, skin edema and surgical site infection after hydrocelectomy, between patients with or without a closed suction drain (CSD). 2. Secondary:
To compare postoperative pain (testalgia) between the two groups of patients.
Study setting: All patients over 18 years of age attending the outpatient department of General Surgery at AIIMS, Bhubaneswar with the diagnosis of idiopathic hydrocele and planned for elective surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All patients over 18 years of age diagnosed with primary hydrocele by clinical and ultrasonographic confirmation, undergoing hydrocelectomy surgery.
排除标准
- •Patient not giving consent to participate
- •Patients with ASA (American Society of Anaesthesiology) grade 3 & 4
- •Patients with congenital or secondary hydrocele
- •Patients with recurrent disease, pyocele or filarial scrotum
结局指标
主要结局
Hematoma
时间窗: Post operative period of 1 month
Post-operative swelling of scrotum with skin discolouration and oozing of blood through the incision site
Skin edema
时间窗: Post operative period of 1 month
Boggy swelling of scrotal wall
Surgical site infection
时间窗: Post operative period of 1 month
Seropurulent discharge from the incision site with systemic signs of infection like fever, tachycardia and local signs like edema, redness and tenderness
次要结局
- Testalgia(post operative period of 1 month)
研究者
Dr. Prakash Kumar Sasmal
Additional Professor,Dept of General Surgery
All India Institute of Medical Sciences, Bhubaneswar