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临床试验/NCT06679504
NCT06679504已完成不适用

Quality of Life After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation

Suez Canal University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年7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
80
试验地点
1
主要终点
Quality of life assessment

研究概览

简要总结

The quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. As many as 10% of the patients report increased pain following surgery. Therefore, the current study aimed to assess the quality-of-life for patients with post-inguinal hernia repair by mesh fixation versus fibrin glue.

详细描述

A wide variety of mesh fixation techniques are available for laparoscopic hernia repair. These can be broadly divided into mechanical and nonmechanical methods. Mechanical methods include sutures and tissue penetrating fixation devices like tackers. Nonmechanical techniques include self-gripping meshes and tissue adhesives (glues).

Mechanical methods are hypothesized to cause more postoperative pain and increased risk of seroma formation, hematoma formation, and osteitis pubis due to tissue trauma and also have increased risk of chronic pain due to nerve entrapment. On the other hand, nonmechanical methods do not have these disadvantages.

Furthermore, the quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. As many as 10% of the patients report increased pain following surgery. Such a chronic pain is often developed due to the use of open inguinal technique along with heavy weight mesh with mechanical fixation techniques, presence of severe pain before surgery and young age. To the best of our knowledge, there are lacking evidence assessing the impact of mesh fixation using fibrin glue upon the quality of life of patients. Therefore, the current study aimed to assess the quality-of-life for patients who had post inguinal hernia repair by mesh fixation versus fibrin glue.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age group of 18-60 years.
  • All types of inguinal hernias.
  • Didn't undergo pervious hernia repair surgery.

排除标准

  • Patients who are unfit for general anesthesia or with American Society of Anesthesiologists (ASA) grade 3 and above.
  • Presence of other groin or abdominal hernias.
  • Patients with complicated hernias such as irreducibility, obstruction, and incarceration.
  • Patients with obesity or morbid obesity BMI >= 35.

结局指标

主要结局

Quality of life assessment

时间窗: 7 days, 15 days, 1 month, 2 months, and 3 months.

The postoperative quality of life has been compared between both groups using SF-36 scoring questionnaire. The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). The higher scores mean better quality of life..

次要结局

  • Postoperative pain assessment(7 days, 15 days, 1 month, 2 months, and 3 months.)

研究者

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

Waleed Ghareeb

Consultant and lecturer of Surgery

Suez Canal University

研究点 (1)

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