The Impact of Comorbidities, Frailty Malnutrition and Sarcopenia on Short-term Mortality in Patients Undergoing Laparoscopic Colon Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- correlation between the development of a postoperative complication within 30 days from surgery and patient-related characteristics (comorbidity, frailty, malnutrition and sarcopenia)
研究概览
简要总结
There are many factors involved in outlining the patient's profile and in defining which factors can be configured as risks related to the surgical act; for the modern surgeon it is no longer possible to identify the patient at risk of complications based on the mere age or some comorbidities historically considered more influential on the surgical outcome, but each patient must be evaluated in its entirety including age, fragility, comorbidity, state nutritional and sarcopenia and, if necessary, implementing preoperative therapeutic strategies aimed at minimizing the impact of some of these factors on the outcome of surgery.
Our study aimed at creating, if possible, an "identikit" of the patient who is more likely to have serious postoperative complications; in order to improve the therapeutic decision and the approach to patients with severe surgical risk since choosing the right treatment for the right patient is essential to obtain a good result.
详细描述
The data and information collected for each patient will initially be extracted through the setting of filters that are specific for date and type of surgical procedure, on the data management system for surgery of the Arcispedale S.Anna (Ormaweb). Subsequently, for patients who meet the inclusion criteria, the data collection will be implemented by evaluating discharge letters, radiological and pathological reports relating to the analysis of the surgical specimen, contained in the management program of the data (SAP network) of the Arcispedale S.Anna di Cona and, if necessary, the digitized archive of the medical records of the Archispedale S.Anna will be queried to analyze the medical records relating to the hospitalization during which the patient underwent surgery. The radiological examinations of the patients, in particular the Computed Tomography of the abdomen, will be further analyzed using specific software for the analysis of the density and muscle conformation of the psoas muscles in order to evaluate the state of sarcopenia and extrapolate the indices related to psoas muscle density, psoas index, and total psoas area.
The following data about each patient will be collected:
- demographic variables as age at the time of surgery, sex, weight, height and BMI, weight loss in the 3-6 months prior to surgery, performance status, ASA score (American Society of Anesthesiologists score) also malnutrition scores according to MUST indexes (Malnutrition Universal Screening Tool) and NRS 2002 (Nutrition Risk Screening 2002) will be taken into account.
- Pre-existing or intercurrent comorbidities aimed at formulating the comorbidity score according to the Charlson Comorbidity Index; and frailty according to the 11 items of the Frailty Index (arterial hypertension, vascular disease, heart disease, vascular encephalopathy or previous transient ischemic attack, diabetes mellitus, inflammatory bowel disease, chronic pulmonary obstructive disease , renal or hepatic insufficiency, neurological or haematological diseases).
- Radiological characteristics of the patient (distance between the anterior-superior iliac spines, density, size and area of the psoas muscles considered at L4 vertebra level) for the constitution of indices of sarcopenia (Bilateral average density of the psoas muscles in HU, Hounsfield Unit Average Calculation , Total psoas area and Psoas Index).
- Characteristics of the surgery (date of surgery, duration in minutes, type of surgery, peri-surgical antibiotic prophylaxis, incision time, any intraoperative complications reported in the official operative document).
- Characteristics of the postoperative hospital stay (duration, complication according to the Clavien-Dindo scale and its possible treatment, date of death or follow-up and time elapsed since surgery).
- Definitive histological examination including macroscopic and microscopic description of the specimen, classification according to TNM score (Tumour, Node, Metastasis), number of lymph nodes removed).
The scales used to evaluate the malnutrition scores, comorbidity and frailty scores and the sarcopenia indices are the following:
- CCI (Charlson Comorbidity Index): score used for the assessment of comorbidities
- 11-items FI (Frailty Index): score used for the assessment of frailty
- M.U.S.T. (Malnutrition Universal Screening Tool) and NRS-2002 (Nutritional Risk Screening): scores used to define the state of malnutrition
- Scores used to define the state of sarcopenia with the aid of the PACS Carestream program.
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
- 否
入选标准
- •age > 18 y.o.
- •colorectal surgery with laparoscopic technique according to the following surgical procedures: right hemicolectomy, left hemicolectomy, segmental resection of the transverse colon, sigmoidectomy.
- •elective surgery
排除标准
- •colorectal surgery with laparotomy technique
- •emergency surgery
- •surgical equipe different from the one operating in the U.O Chirurgia 1 at Sant'Anna University Hospital in Ferrara
结局指标
主要结局
correlation between the development of a postoperative complication within 30 days from surgery and patient-related characteristics (comorbidity, frailty, malnutrition and sarcopenia)
时间窗: Preoperative assessment of pre-existing comorbidities, the frailty, malnutrition and sarcopenia status and within 30 days from surgery for Clavien Dindo complication score
presence of a proportional correlation between the development of postoperative complications and its the extent within 30 days from surgery assessed according to the Clavien Dindo scale (mild complications 1-2; severe complications 3-4-5) and patient-related factors that may have influenced the occurrence of postoperative complications. For assessing the pre-existing comorbidities we used the Charlson Comorbidity Index (CCI), the level of frailty will be assessed by the 11-items Frailty Index, malnutrition is assessed by two scores (M.U.S.T. and NRS-2002) allowing a stratification of the patient's risk of malnutrition. In addition, the level of preoperative sarcopenia present on computed tomography will also be assessed using specific software to calculate the average density of the psoas muscles, Psoas Index (PI) and Total Psoas Area (TPA).
short-term mortality rates within 30 days from surgery
时间窗: Within 30 days from surgery
short-term (30 days after surgery) mortality rate in patients undergoing resective colorectal surgery
次要结局
- relatedness between the average density sarcopenia indices, HUAC, PI, TPA and the distance between the anterior-superior iliac spines and the size of the psoas muscles (RPSI)(prior to surgery)
- Assessing the sarcopenia status in patients undergoing colon laparoscopic surgery(Prior to surgery)
- Assessing comorbidity status in patients undergoing colon laparoscopic surgery(Prior to surgery)
- Assessing the malnutrition status in patients undergoing colon laparoscopic surgery(Prior to surgery)
- Assessing the frailty index in patients undergoing colon laparoscopic surgery(Prior to surgery)
研究者
Gabriele Anania
Associate Professor
University Hospital of Ferrara