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临床试验/NCT04347772
NCT04347772Unknown不适用

Intensive Perioperative Nutrition Therapy

Universiti Putra Malaysia2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
68
试验地点
2
主要终点
Length of Bowel function

研究概览

简要总结

Perioperative malnutrition is common in patients undergoing gastrointestinal and oncological surgery and it also associated with longer hospital stays, reduced responses to and increased complications from therapies, increased costs, poorer quality of life and lower survival rate. Evidence has shown that appropriate perioperative nutrition therapy have a significantly improve perioperative outcomes. Current practice emphasises the roles of early nutrition therapy as early intervention in order to combat the post-operative complications of patients and the implementation is now widely adopted. However, there is very limited data to date on the effects of perioperative nutrition therapy in patients before hospital admission, during hospital stay and after discharge to prevent the post-operative complications. Therefore, there is a need to study in this area in order to determine the effects of perioperative nutrition therapy to overcome the post-operative complications in patients undergoing surgery. This is a pragmatic randomized clinical trial will be conducted among sixty eight adults patient undergoing major elective surgery in Hospital Serdang. Participants will be randomized to one of two groups by means of sealed envelope into Intervention Group (SS) or Control Group (NN). All data will be collected during a face to face interview, blood sampling and direct anthropometric measurement with the participants at Hospital Serdang. The effects of intervention between treatment groups on outcome parameters will be carried out by using the SPSS General Linear Model (GLM) for repeated measure procedure. The perioperative nutrition therapy intervention implemented in the study will serve as a baseline data for providing an appropriate nutritional management in patients undergoing surgery.

详细描述

Malnutrition is well reported and common in surgery patients. Surgery itself leads to inflammation corresponding with the extent of the surgical trauma, and leads to a metabolic stress response. The existing research suggests that patients undergoing surgery for upper gastrointestinal or colorectal cancer are particularly at risk of malnutrition. Recent research from Malaysia shows almost similar findings from previous studies which is about 29.1% of surgical patients were malnourished and shows increase length of hospital stay, higher rate of surgical site infection and mortality.

Nutrition requirement for surgery is higher if compared with normal requirement in order to support speedy recovery. However, most of the patients especially cancer patients do unable to achieve even 50% energy requirement before operation. This will cause further depletion of nutritional status of patient. In conjunction with this, patients with suboptimal nutritional status pre-operatively will have a higher risk of postoperative complications. Interestingly, one of Malaysian study shows significant number of post-surgery complications compared to pre-surgery which was associated to the poor level of nutrition. The success of surgery does not depend exclusively on technical surgical skills but also on metabolic intervention therapy, taking into account the ability of patient to carry a metabolic load and to provide appropriate nutrition support. In fact, in patient with cancer, management during perioperative period may be crucial for long term outcome.

Nutrition therapy is the provision of nutrition or nutrients either orally (regular diet, therapeutic diet, e.g. fortified food, oral nutritional supplements) or via enteral nutrition (EN) or parenteral nutrition (PN) to prevent or treat malnutrition. Dietary advice or nutrition counselling is part of a nutrition therapy. In the surgical patient, the indications for nutritional therapy are prevention and treatment of catabolism and malnutrition. This affects mainly the perioperative maintenance of nutritional state in order to prevent postoperative complications. It is strongly recommended not to wait until severe disease-related malnutrition has developed, but to start nutrition therapy early, as soon as a nutritional risk becomes apparent.

Early oral feeding is the preferred mode of nutrition for surgical patients. Avoidance of any nutritional therapy bears the risk of underfeeding during the postoperative course after major surgery. Considering that malnutrition and underfeeding are risk factors for postoperative complications, early enteral feeding is especially relevant for any surgical patient at nutritional risk, especially for those undergoing upper gastrointestinal surgery e.g. for cancer. In addition, appropriate perioperative nutrition therapy has been shown on improvement of perioperative outcomes especially in gastrointestinal and oncologic surgical patients.

Early nutrition intervention or perioperative EN is optimising patient's nutritional status so that their bodies can receive optimal effects during surgical. The general indications for nutritional support therapy in patients undergoing surgery are the prevention and treatment of undernutrition, i.e. the correction of undernutrition before surgery and the maintenance of nutritional status after surgery, when periods of prolonged fasting and/or severe catabolism are expected. Morbidity, length of hospital stay, and mortality are considered principal outcome parameters when evaluating the benefits of nutritional support.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those who receiving elective major surgery treatments
  • Aged from 18 years old to 80 years old
  • Malaysian
  • Able to communicate verbally
  • MST score ≥ 2
  • Provided and signed informed consent

排除标准

  • Those who had received pre-operative enteral or PN
  • Those who requiring emergency surgery
  • Complicated with chronic diseases and fluid retention (renal/ cardiovascular/ pulmonary/ hepatic)
  • Those who participated in other research study.

结局指标

主要结局

Length of Bowel function

时间窗: 2 months

To compare the effect of intensive perioperative nutrition therapy versus usual care on the length of bowel function. The duration of bowel start function post-operatively in hours or days will be recorded. The duration covers from zero hours after surgery until the first day of bowel function presented. The start of bowel function is the first day of commencement of any type of fluids or solid food given

Length of solid food toleration

时间窗: 2 months

To compare the effect of intensive perioperative nutrition therapy versus usual care on the length of solid food toleration. The duration of solid food toleration post-operatively in hours or days will be recorded. The duration covers from zero hours after surgery until the first day of reintroduction of solid food.

Length of hospital stay

时间窗: 2 months

To compare the effect of intensive perioperative nutrition therapy versus usual care on the length of hospital stay. The duration of hospital stay in days will be recorded. The duration covers from the day of ward admission (before operation) until discharge (after operation).

次要结局

  • Nutritional status - Serum white blood cell(2 months)
  • Nutritional status - Serum C-reactive protein (CRP)(2 months)
  • Nutritional status - Dietary Intake(2 months)
  • Functional status - handgrip strength(2 months)
  • Nutritional status - Mid Arm Circumference (MAC)(2 months)
  • Nutritional status - Tricep Skinfold (TSF)(2 months)
  • Nutritional status - Serum Albumin(2 months)
  • Nutritional status - Serum Haemoglobin(2 months)
  • Malnutrition Status - The scored Patient Generated Subjective Global Assessment (PG-SGA)(2 months)
  • Nutritional status - Body Mass Index (BMI)(2 months)

研究者

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

Zalina Abu Zaid

Principal Investigator

Universiti Putra Malaysia

研究点 (2)

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