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临床试验/NCT07681700
NCT07681700已完成不适用

Evaluating the Effect of Drainage on the Incidence of Seroma After Laparoscopic Trans Abdominal Preperitoneal Inguinal Hernia Repair

Cairo University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Incidence of patients suffering from Seroma

研究概览

简要总结

The aim of the study is to evaluate the effect of drainage on the incidence of seroma after laparoscopic transabdominal preperitoneal inguinal hernia repair.

详细描述

Inguinal hernia repair is one of the most common surgical conditions encountered in primary care settings. Globally, around 20 million groin hernia repairs are performed each year. Surgical procedure is the gold standard treatment for inguinal hernia repair.

Laparoscopic hernioplasty is suitable for patients with inguinal hernia who can undergo general anesthesia, especially in cases like hernia recurrence after open repair, bilateral hernias, and simultaneous procedures like cholecystectomy.

Although open mesh repair has already demonstrated a low recurrence rate, laparoscopic mesh repair has become increasingly popular in recent years due to its benefits, including a better view of the groin anatomy, ease in addressing bilateral hernias, and superior cosmetic outcomes. The two most widely used laparoscopic mesh repair techniques are Totally Extra peritoneal (TEP) and Trans abdominal Preperitoneal (TAPP) repair, both of which are based on the myopectineal orifice theory. The key difference between TEP and TAPP lies in the method used to access the preperitoneal space.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged from18 to 70 years.
  • Both sexes.
  • Patients were diagnosed with all types of inguinal hernia who are candidates for elective trans-abdominal Preperitoneal (TAPP) repair.

排除标准

  • Previous history of pelvic or lower abdominal surgery.
  • Coagulopathy.
  • Any condition contraindicating laparoscopic surgery.
  • Patients with complicated hernia (irreducible/incarcerated or obstructed/strangulated hernia).
  • Active infections.
  • Uncorrected medical comorbidities.
  • Bilateral inguinal hernia either preoperative or intraoperative diagnosis.

结局指标

主要结局

Incidence of patients suffering from Seroma

时间窗: 6 months post-procedure

Incidence of patients suffering from Seroma in each group after Transabdominal preperitoneal inguinal hernia repair.

次要结局

  • Degree of pain(24 hours post-procedure)
  • Degree of patient satisfaction(24 hours post-procedure)
  • Measurement of operative time(Till closure of the skin (Up to 60 minutes).)
  • Incidence of recurrence(6 months post-procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Abdirashid Ahmed

MSc Candidate in General Surgery, Faculty of Medicine, Cairo University, Giza, Egypt

Cairo University

研究点 (1)

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