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临床试验/NCT04690179
NCT04690179Unknown不适用

Sarcopenia and Sarcopenic Obesity in Complex Abdominal Wall Surgery: Postoperative Complications and Their Impact on Recurrence

Hospital Universitario Ramon y Cajal0 个研究点目标入组 150 人开始时间: 2021年1月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
主要终点
Complications

研究概览

简要总结

The objective of our study is to evaluate the prevalence of sarcopenia and sarcopenic obesity in our surgical population and their relationship in postoperative complications after complex abdominal wall surgery and its influence on hernia recurrence.

This is a retrospective study on a prospective maintains database of complex abdominal wall surgery.

We select patients with defects larger than 10 cm from any location (W3 of the EHS classification), excluding other causes of complex abdominal wall in order to have a more homogeneous sample.

Pre-surgical computed tomography (CT) scans of the selected patients will be reviewed to establish the diagnosis of sarcopenia, obesity, sarcopenia-obesity or the absence of these (normal). The CT scans will be reviewed by two trained investigators, blinded to postoperative complications and survival. In case of disagreement, a third investigator will break the tie.

The radiological diagnosis of sarcopenia has been established based on the skeletal muscle mass index. Skeletal muscle mass measurement will be performed in a cross-section in the pre-surgical CT scan at the level of the third lumbar vertebra (L3).

The BMI, the Visceral Fat Area and the Subcutaneous Fat Area (SFA) will also be measured. With the previous data, the VFA / SFA ratio will be calculated.

The study will be completed with the collection of sociodemographic data, comorbidities and presence of risk factors for the development of incisional hernia, ASA, size and location of the hernia, surgical technique, postoperative complications according to Clavien-Dindo, stay, readmission, late complications and hernia recurrence. Likewise, the presence or absence of recurrence will be collected.

Statistical analysis will be performed to see if there is a correlation between sarcopenia and sarcopenic obesity with the appearance of local and systemic complications and recurrence. To evaluate the independent contribution of each variable to the presence of complications, a univariate and multivariate logistic regression analysis will be performed.

详细描述

The incidence of incisional hernia after laparotomy is as high as 20% according to current literature, and repair of incisional hernias is one of the most frequently performed operations by general surgeons. A not inconsiderable part of these hernias, due to their size, complexity or degree of contamination, is considered complex abdominal wall. Surgery in these patients is a major surgery that is accompanied by a marked anabolic response and a high incidence of local and systemic complications and a high recurrence rate.

In recent years, there has been a growing interest in evaluating the relationship between surgical results and body composition. Sarcopenia is a new concept that reflects the loss of skeletal muscle mass. Recent publications have recognized sarcopenia as a prognostic factor in the evolution of surgical patients operated on for cancer, transplants, trauma and emergency surgery, but there is still little evidence that it plays a role in surgery for the complex abdominal wall.

The prevalence of sarcopenia is growing progressively. One of the causes may be that life expectancy has increased worldwide and is well known that ageing is associated with the progressive loss of muscle mass (9).

Sarcopenia can be classified into primary, which is caused by ageing, and secondary, which is caused by immobility or diseases such as cancer (10).

On the other hand, obesity is defined as abnormal or excessive accumulation of fat mass. It is a major public health problem and is recognized as a risk factor for global morbidity and mortality. Its incidence continues to increase worldwide and its prevalence has doubled since 1980 (11). It is well documented that visceral obesity is associated with high complication rates in patients who undergo abdominal wall surgery (12-15).

研究设计

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

入排标准

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

入选标准

  • Patients operated for an incisional hernia with a transverse diameter greater than 10 cm measured in the preoperative Computed Tomography.

排除标准

  • Not having a preoperative Computed Tomography performed in the three months before the operation.

结局指标

主要结局

Complications

时间窗: Thirty postoperative day

Presence of local or systemic complications

Recurrence

时间窗: Twenty four postoperative month

Appearance of an incisional hernia recurrence

次要结局

未报告次要终点

研究者

发起方
Hospital Universitario Ramon y Cajal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luis Blázquez Hernando

Surgeon

Hospital Universitario Ramon y Cajal

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