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临床试验/NCT05734222
NCT05734222招募中不适用

Optimization of Surgical Treatment of Patients With Postoperative Median and Median-lateral Ventral Hernias

Samara State Medical University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
1
主要终点
rate of seroma

研究概览

简要总结

The goal of our work of optimization of the treatment of postoperative hernias is to improve the results of treatment of patients with median and median-lateral postoperative hernias of medium (W2) and large (W3) sizes by developing new surgical techniques. The main questions it aims to answer are:

  1. To study the topographic and variant anatomy of vessels and nerves in the retromuscular, preperitoneal, postperitoneal and pre-abdominal cell spaces of the anterior abdominal wall. To determine the most probable sources of blood flow and lymph from the anatomical formations forming the bed of the endoprosthesis.
  2. To develop technical, surgical techniques that allow to form an implant bed with minimal traumatization of blood vessels and nerves and reduce the risk of postoperative complications.
  3. To develop a technique for plasty of the anterior abdominal wall in mid-lateral postoperative hernias with a combination of retromuscular and subaponeurotic spaces.

The researchers will compare an experimental group in which a new method of preparing the implant place will be used and a control group in which standard methods of treating postoperative ventral hernias were used to see whether the new method affects the improvement of the postoperative period and the reduction of complications.

详细描述

Relevance of the research topic:

The problem of surgical treatment of postoperative ventral hernias (POVG) remains relevant to the present time. PWS account for 20-22% of the total number of hernias and occupy the second place in frequency of occurrence after inguinal hernias. Despite the rapid development of minimally invasive technologies in abdominal surgery, according to various authors, the frequency of occurrence of POVG after elective operations reaches 4-18.1%, and after urgent operations - 18.1-58.7% The use of mesh implants in the treatment of POVH reduced the number of relapses, but led to an increase in the frequency of postoperative wound complications, reaching, according to various authors, impressive figures - 20.9-49.2%. Complications of hernioplasty lead to an increase in postoperative beda day and an outpatient period of follow-up treatment, a sharp increase in material costs for treatment. Treatment of late complications of allogernioplasty (postoperative fistulas, mesh implant rejections) requires repeated additional hospitalizations and outpatient treatment courses.

In modern times, one of the priority areas of scientific research in herniology is the improvement of prosthetic plastics and the development of methods for the prevention of seromas, which are the most common complication of the course of the postoperative period and occur in a wide range from 0.8% to 60%.

Retromuscular plasty of the anterior abdominal wall is currently the most physiological and reliable method of surgery for hernias of median localization. Optimal methods of plastic surgery for median and lateral hernias are indicated, including in clinical recommendations, but the question of plastic surgery for ventral postoperative hernias of median-lateral localization remains open.

Variant anatomy of vessels and nerves of the anterior abdominal wall for herniologists is important in the development of surgical techniques that minimize traumatization of neurovascular bundles during anterior abdominal wall plastic surgery. In this way, it is possible to reduce blood and lymph flow from cellular spaces, preserve the neurovascular trophic anatomical formations of the anterior abdominal wall and reduce the risk of postoperative complications. Based on the above, the development of surgical techniques that minimize traumatization of neurovascular bundles is an urgent task. The development of plastic methods for combined mid-lateral hernias is also an urgent task of modern surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

盲法说明

  1. The comparison groups will include patients who underwent retromuscular plastic surgery followed by aspiration drainage of the prosthesis bed. When analyzing the results, the presence of obesity and coagulopathy will be taken into account, CT and ultrasound examination will be carried out. Special attention will be paid to the presence and volume of liquid formations in the implant bed.

  2. Immediate results will be evaluated up to 1 year Criteria for evaluating immediate results: treatment time, pain syndrome, the presence of seromas and hematomas, their infection and suppuration.

  3. Long-term results will be evaluated in terms from 1 to 1.5 years. Evaluation criteria: the presence of recurrent hernia, the presence of late complications - fistulas, seromas requiring drainage, pain syndrome.

入排标准

年龄范围
25 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The study will include patients with postoperative ventral hernias of median and lateral localization and an average hernial gate width from 4.1 to 15 cm (W2-W3 according to the EHS classification).. The size of the hernial gate is determined by CT.

排除标准

  • Patients without postoperative ventral hernias median and lateral localization

结局指标

主要结局

rate of seroma

时间窗: 5 days

rate of development of seroma in postoperative area

rate of hematoma

时间窗: 5 days

rate of development of hematoma in postoperative area

Recurrence rate

时间窗: One year

Rate of hernia recurrences diagnosed at clinical and/or ultrasound examination

次要结局

  • Pus(7 days)
  • Persisting postoperative pain(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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