跳至主要内容
临床试验/NCT05913245
NCT05913245招募中不适用

Impact of the Preoperative Carbohydrate Loading for Enhancing Recovery After Radical Cystectomy: a Randomized Controlled Trial.

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年3月30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
66
试验地点
2
主要终点
Insulin resistance

研究概览

简要总结

In recent years, the world of anesthesiology is questioning one of its great dogmas: Are so many hours of strict fasting necessary in patients who are candidates for elective surgeries? The main objective of our clinical trial will be demonstrate whether preoperative oral loading with hydrocarbonate beverages reduces the time of return of intestinal function in the postoperative period compared to water administration and strict fasting in patients undergoing elective radical cystectomy.

详细描述

Many anaesthesiology societies now recommend intake of clear fluids (water, tea or coffee without milk, juices without pulp) up to two hours before induction of anaesthesia for most patients undergoing elective surgery. This change the traditional practice of overnight fasting, while reducing thirst in the hours before surgery and seems to attenuate the response to the stress that results from a major operation, such as activation of endocrine and inflammatory systems which leads to tissue catabolism and insulin resistance. Among all the complications, one of the most frequent in patients undergoing mayor surgeries is undoubtedly paralytic ileus. The Enhanced Recovery After Surgery (ERAS) guidelines emphasize the importance of preventing this event. To prevent ileus, prokinetic agents such as metoclopramide are used, which although it has not been shown to shorten the period until the first flatulence or the first peristaltic movement, decrease nausea and vomiting. Chewing gum is another measure that is carried out, since it stimulates peristalsis and this measure if it had significant effects in time until first flatulence and in time until first peristaltic movement. In recent years there has been a great change in the perioperative management of patients who will undergo a radical cystectomy. The weight of traditional perioperative care has been an important barrier to the implementation of Fast Track (FT) protocols, since it is difficult to change a therapeutic strategy that has been carried out for decades. The positive results obtained in colorectal surgery led to Fast Track being implemented in other types of surgery similar to colorectal surgery such as radical cystectomy. Although there is apparently widespread enthusiasm for the implementation of Fast Track protocols, evidence of the use of this type of protocols in cystectomy is not robust, numerous studies claim that there is a big difference between the application of FT and the application of traditional measures in terms of length of hospital stay or complications. Because of this, more large-volume randomized experimental studies of patients are needed. This randomized double blind placebo-controlled trial of preoperative oral carbohydrate (CHO) treatment in patients undergoing elective radical cystectomy will investigate whether this treatment reduced the time of return of intestinal function. Secondary outcomes will be the incidence of infection of surgical wounds, the incidence of postoperative complications, the length of hospital stay and early postoperative fatigue in the three groups of patients undergoing this type of surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Written informed consent.
  • Patients older than 18 years old proposed for radical cystectomy.

排除标准

  • American Society of Anesthesiologists (ASA) classification grade: IV
  • Renal failure (creatinine levels above 3 mg/dL or dialysis)
  • Liver failure (Child-Pugh B or higher)
  • Gastroesophageal reflux disease.
  • Gastrointestinal obstruction.
  • Ongoing treatment with corticosteroids.
  • Previous infections within the last 3 months.

结局指标

主要结局

Insulin resistance

时间窗: 1 Day of surgery

Determinate the insulin resistance measured by the homeostatic model assessment (HOMA) index.

次要结局

  • Insulin resistance(Postoperative day #1)
  • To determine the recovery time of intestinal activity by measuring time to first bowel movement.(1 week)
  • To compare and determine whether there are differences between the incidence of infection of surgical wounds, the incidence of postoperative complications and the length of hospital stay in the three groups of patients undergoing this type of surgery.(Up to 30 days)

研究者

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

Daniel López-Herrera Rodriguez

PhD

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

研究点 (2)

Loading locations...

相似试验