跳至主要内容
临床试验/NCT02984917
NCT02984917Unknown不适用

Anterior Transversalis Fascia Approach Versus Preperitoneal Space Approach for Inguinal Hernia Repair in Residents in Northern China: a Prospective, Multi-center, Randomized, Controlled Trial

The Fourth Affiliated Hospital of China Medical University9 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2017年2月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
9
主要终点
VAS pain score

研究概览

简要总结

To investigate the advantages and disadvantages of the anterior transversalis fascia approach versus the preperitoneal approach for inguinal hernia repair in residents from northern China regarding common postoperative complications (including acute and chronic pain, wound infection, rates of wound infection, hematoma, seroma, and hernia recurrence) and severe postoperative complications.

详细描述

History and current related studies Inguinal hernia is a common surgical disease that manifests as protrusion of abdominal cavity contents through the inguinal canal because of an abdominal wall defect. It is more common in males than in females, with an overall incidence of 5-10%. Methods for surgical repair of abdominal wall defects in the inguinal region are classified as either 'tension'repairs or 'tension-free' repairs. Herniorrhaphy through repair of the posterior wall of the inguinal canal was first described by Bassini in 1887, and is regarded as a classic surgical method.

As understanding of the anatomic location and pathophysical characteristics of inguinal hernia developed, the American surgeon Lichtenstein proposed a new concept of tension-free herniorrhaphy. This technique was quickly adopted worldwide because of its advantages including minimal invasion, technical ease, effectiveness, low complication rate, low recurrence rate, and allowance of resumption of unrestricted physical activity. The most common technique is open tension-free herniorrhaphy.

Many surgical repair methods involving patches (of varying types and materials) are available for inguinal hernia repair.

Tension-free herniorrhaphy methods include anterior transversalis fascia repair, preperitoneal repair, abdominal cavity patch repair and combined repair approaches. Lichtenstein herniorrhaphy is the representative technique of anterior transversalis fascia repair. Preperitoneal repair techniques include transabdominal preperitoneal, total extraperitoneal, and Kugel repair techniques. The combined repair approaches refer to tension-free herniorrhaphy using a modified Kugel patch and the Ultrapro hernia system.

There are few reports on the effects of different inguinal hernia repair approaches on postoperative complications, particularly regarding severe postoperative complications, in patients in northern China. The incidence of severe complications after inguinal hernia repair is relatively low, but this surgery can lead to physical impairment or organ dysfunction that greatly decreases patient quality of life and places a heavy burden on the patient's family and society. At present, there is a scarcity of clinical evidence from large-sample, randomized, controlled trials investigating the effectiveness of inguinal hernia repair via the anterior transversalis fascia approach versus the preperitoneal approach.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Diagnosed with primary unilateral inguinal hernia
  • Aged 18-80 years
  • American Society of Anesthesiologists (ASA) classification I-II
  • Provision of informed consent

排除标准

  • Severe organ dysfunction or inability to tolerate surgery
  • Hernia recurrence
  • Giant hernia (inner size of the hernia > 4 cm)
  • Scrotal hernia
  • Incarcerated inguinal hernia
  • Inability to complete follow-up or questionnaire because of mental disorder or other reasons
  • History of preperitoneal surgery, such as radical prostatectomy

结局指标

主要结局

VAS pain score

时间窗: changes of month 1, month 3, month 12, month 24 after operation

Visual Analogue Scale(VAS) pain score is one of the most commonly used tools for assessing pain.It comprises a 10 cm line with 0 at one end, representing no pain, and 10 at the other end, representing the worst pain imaginable; the patient places a mark on the line to indicate the degree of pain that they are experiencing.

次要结局

  • Postoperative complications(changes of month 1, month 3, month 12, month 24 after operation)

研究者

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

Hangyu Li

Chief Physician

The Fourth Affiliated Hospital of China Medical University

研究点 (9)

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