跳至主要内容
临床试验/CTRI/2024/09/073604
CTRI/2024/09/073604尚未招募3 期

Role of scrotal support in reducing post operative pain, edema, hematoma following laparoscopic inguinal hernia surgery: A randomized control trial

Deeksha kumbhawat1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年9月23日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
To assess and compare the incidence of post-operative scrotal complications viz., scrotal pain, hematoma and seroma formation at 24 hours, 72 hours and 7 days after laparoscopic groin hernia surgery in patients with uncomplicated, incomplete inguinal hernia with or without the use of scrotal support.

研究概览

简要总结

The practice of supporting the scrotum following inguinal hernia surgery is a universal practice. The groin hernia surgery has evolved from open repair to minimally invasive one over time with consequent decrease in incidence of post-operative local complications. The utility of scrotal support in reducing local complications following laparoscopic repair of inguinal hernia has seldom been investigated despite the advantages of minimally invasive surgery. Through this RCT, we attempt to investigate the utility of scrotal support in preventing post-operative pain, edema and hematoma in patients undergoing laparoscopic repair for small and medium sized inguinal hernia

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Male

入选标准

  • 1.ASA grade 1 2.Small and medium sized hernia 3.Uncomplicated inguinal hernia.

排除标准

  • 1.Patient not willing 2.Bilateral hernia 3.Patient on anticoagulant medications 4.Patient with coexisting scrotal or testicular pathology.

结局指标

主要结局

To assess and compare the incidence of post-operative scrotal complications viz., scrotal pain, hematoma and seroma formation at 24 hours, 72 hours and 7 days after laparoscopic groin hernia surgery in patients with uncomplicated, incomplete inguinal hernia with or without the use of scrotal support.

时间窗: 24Hr, 72Hr, 7 days after surgery

次要结局

  • To compare the incidence of scrotal complications with duration of surgery, type of inguinal hernia (direct or indirect), type of inguinal hernia surgery (TAPP or TEP) & between small & medium sized inguinal hernias.(24Hr, 72Hr, 7 days after surgery)

研究者

发起方
Deeksha kumbhawat
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Deeksha kumbhawat

AIIMS NEW DELHI

研究点 (1)

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