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临床试验/NCT06815822
NCT06815822招募中不适用

Prevention of Postoperative Hernias in Emergency Surgery

Jan Kochanowski University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Incisional hernia

研究概览

简要总结

The aim of this observational study is to understand the risk factors and incidence of postoperative hernias among patients undergoing emergency surgery. The main question it aims to answer is:

What is the incidence of postoperative hernias in this group of patients?

A brief telephone interview will be conducted with participants who will be included in this study one year after the surgery. If the presence of a postoperative hernia is suspected, the patient will be invited to a follow-up visit to the surgical clinic, where the diagnosis will be confirmed by imaging tests.

详细描述

Introduction Emergency and urgent surgical procedures carry a high risk of complications. One of the long-term complications is postoperative hernia. Despite numerous studies analysing methods to reduce the incidence of this complication, it remains a significant surgical problem. Studies covering both elective and emergency procedures report that postoperative hernias occur in 2% to 40% of operated patients. The discrepancies in reported incidence rates may result from the asymptomatic nature of some hernias. An example is port-site hernias, for which the exact incidence is not fully determined. Another significant surgical issue is parastomal hernias, occurring in up to 50% of patients. Differences in the incidence of postoperative hernias also arise from the method and duration of patient follow-up. Due to these factors and the specificity of emergency procedures, the frequency of postoperative hernias is often underestimated in this patient group.

Considering the clinical consequences of postoperative hernias, preventing their occurrence is crucial. According to the literature, patients with diabetes, chronic lung disease, smoking habits, obesity, immunodeficiency, or a history of previous abdominal surgeries are at high risk of developing postoperative hernias. The European Hernia Society guidelines highlight the need for further research on methods for preventing postoperative hernias. The surgical approach and technique also influence the incidence of this complication. One of the technical factors is the method of fascial closure. According to the World Society of Emergency Surgery guidelines, the "small bites" technique is suggested for closing midline laparotomies to prevent postoperative hernias and wound complications in emergency surgery; however, the evidence comes from elective procedures. These guidelines emphasise the necessity of conducting prospective studies to confirm the efficacy of this technique in emergency and urgent surgeries. Other aspects of surgical technique, such as suture material, routine use of subcutaneous or intra-abdominal drains, and their impact on postoperative hernia incidence, remain a topic of debate.

The number of large, multicentre studies analysing prevention strategies for this complication is limited, especially concerning postoperative management. According to the available literature, including the European Hernia Society guidelines, the use of abdominal binders and the timing of full activity resumption remain controversial and require further investigation. Another known risk factor for postoperative hernias is surgical site infection, which affects approximately one-third of patients undergoing emergency procedures. A less common but significant surgical complication influencing postoperative hernia development is wound dehiscence, with an estimated incidence of around 4%. Both surgical site infections and wound dehiscence are associated with increased perioperative mortality, making the optimisation of therapeutic strategies to reduce their occurrence essential.

Objective The aim of this study is to determine the incidence of postoperative hernias among patients undergoing emergency surgery and to identify modifiable risk factors for their occurrence. Understanding these factors will help reduce the incidence of this complication and improve treatment outcomes by developing effective preventive strategies for this specific patient group.

Methodology This study will be a nationwide, prospective, cohort, multicentre observational study conducted from 1 June 2025 to 31 December 2026. It will be coordinated by the Department of Surgical Medicine with the Laboratory of Medical Genetics, Medical College, Jan Kochanowski University in Kielce. The study has been approved by the Bioethics Committee of Medical College, Jan Kochanowski University in Kielce (approval number: 5/2025).

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incisional hernia

时间窗: From the moment of inclusion until one year from the date of surgery.

Occurrence of postoperative abdominal hernia in the incision line.

Port-site hernia

时间窗: From the moment of inclusion until one year from the date of surgery.

Occurrence of port-site hernia after laparoscopy.

Parastomal hernia

时间窗: From the moment of inclusion until one year from the date of surgery.

Occurrence of a parastomal hernia after open/laparoscopic stoma formation

次要结局

  • Burst abdomen(From the moment of inclusion in the study until 30 days after surgery.)
  • Surgical site infection(From the moment of inclusion in the study until 30 days after surgery or 90 days in the case of mesh use (if the primary procedure was repair of an incarcerated hernia or the mesh was placed to prevent postoperative hernia).)

研究者

发起方
Jan Kochanowski University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bartosz Molasy

MD, PhD

Jan Kochanowski University

研究点 (1)

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