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临床试验/NCT04576533
NCT04576533招募中不适用

Effects of Walking Out From Operating Room on Postoperative Recovery of Patients Undergoing Laparoscopic Colorectal Surgery

Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Length of hospital stay after surgery

研究概览

简要总结

Early mobilization is considered as an important strategy to enhance postoperative recovery. However, direct association between very early mobilization and improved recovery needs randomized control trials to prove. This study proposes the program of walking out from operating room (WOFOR) after surgery, which means that encouraging patients to walk out from the operating room and return to the ward by walking under the condition of painlessness, clear consciousness and normal muscle strength of lower limb. The aim of this randomized controlled trial is to investigate the effect of WOFOR on the postoperative recovery of patients undergoing laparoscopic colorectal surgery.

详细描述

Postoperative bed rest increases the risk of complications such as thromboembolism and intestinal adhesion. Encouraging early mobilization after surgery should be important, although actual effects of early mobilization still need randomized control trails to prove. The aim of this randomized controlled trial is to investigate the effect of walking out from operating room (very early mobilization after surgery) on the postoperative recovery of patients undergoing laparoscopic colorectal surgery.

A sample size of 300 patients in each group will be selected by a prior power analysis on the basis of the following assumptions: (1) an absolute reduction in the length of the hospital stay by 1 day ( 9 days in intervention group and 8 days in control group), (2) standard deviation 3 days, (3) α=0.05, (4) power 80% and .(5) missed follow-up rate 5%.

Patients will receive written and verbal information about the trial before written consent is obtained. The randomization will take place before the day of the surgery and the patients will be assigned to either intervention (return to ward by walking) or control group (return to ward by lying on the transporting bed ). A stratified randomization with three factors including sex(female or male), tumor site (colon or rectum) and age (18-40 or 41-65 years old ) will be performed to ensure an even spread. The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a statistician.

The patients will receive general anesthesia combined with epidural analgesia. After surgery, the patients will be evaluated whether fulfilling the criteria for mobilization including stable physiological parameters, consciousness, normal level of orientation and muscle strength, and painlessness every ten minutes. If patients fulfill the criteria, they will receive different methods of returning to the ward based on the grouping. In the control group, the patient will return to the ward by lying on the transporting bed. In the intervention group, the patients will be raised to a sitting position for five minutes. If the patients do not complain any discomfort and have stable physiological parameters, they will be encouraged to stand. If standing do not cause any discomfort, they will be encouraged to walk within the range of 5-meter long and 60-centimeter wide. If patients can walk within the range, they will return to the surgical ward by walking under the protection of medical staffs.

Then, all study patients will be subject to the same management such as the guidance of drink and diet recovery, the guidance of mobilization in the ward (the duration and distance of walking in the ward will be recorded every day), nutrition supplement after surgery, and the criteria of drainage removal and hospital discharge. The outcomes such as the length of hospital stay after surgery will be recorded and analyzed to evaluate the effects of walking out from the operating room. The analysis of Intention-to-treat and Per-protocol-sets will be both performed by statisticians.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Age 18-65 Years old
  • 2. scheduled for laparoscopic colectomy or laparoscopic rectectomy surgery (Dixon technique)
  • 3. American Society of anesthesiology (ASA) grade I or grade II

排除标准

  • 1. Patients have severe cardiac diseases (cardiac function grading greater than grade 3/arrhythmia including sick sinus syndrome, atrial fibrillation, atrial flutter, atrioventricular block, frequent ventricular premature, multiple ventricular premature, ventricular premature R on T, ventricular fibrillation and ventricular flutter/acute coronary syndrome) or respiratory failure or hepatic failure or renal failure;
  • 2. Patients with poor blood glucose control (glycosylated hemoglobin>7%);
  • 3. Patients with poor blood pressure control (receive regular antihypertensive medical treatment but still have systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg );
  • 4. Patients have schizophrenia, epilepsy, Parkinson's disease, mental retardation, or hearing impairment.
  • 5. Patients have thrombosis such as in lower extremity or in other veins.
  • 6. Patients have neuromuscular disorders affecting lower limb activity, such as myasthenia gravis and cerebral infarction, which cause lower limb muscle weakness;
  • 7. Patients have contraindications for epidural puncture.
  • 8. Patients refuse to sign informed consent for research.

结局指标

主要结局

Length of hospital stay after surgery

时间窗: at hospital discharge(expected 7 days after surgery)

hospital stay time from operation completion to actual hospital discharge

次要结局

  • Time to fulfill the criteria of hospital discharge (recovery time)(expected 7 days after surgery)
  • Severity of postoperative nausea and vomiting(at 1-day, 2-day after surgery(up to 2 days after surgery))
  • Time to the removal of drainage tube(at the time of drainage removal(expected average of 4 days after surgery))
  • Postoperative recovery score using 40-item quality of recovery scoring system(QoR-40)(at 1-day, 2-day, 3-day, 4-day after surgery and at hospital discharge (up to 8 days after surgery)
  • Incidence of major cardiovascular and cerebrovascular adverse events within 30 days after operation(30 days after surgery)
  • Re-admission incidence within 30 days after operation because of surgical complication(30 days after operation)
  • Anxiety state evaluated by State-Trait Anxiety Inventory Form. The form used in this study is the Chinese version.(the day before surgery, and at 1-day, 2-day, 3-day, 4-day after surgery and at hospital discharge(up to 8 days after surgery)
  • Time to first flatus after surgery(at the time of first exhaust after surgery(expected average of 2 days after surgery))
  • The volume of drainage after surgery(expected average of 4 days after surgery)
  • Incidence of surgical complications within 30 days after surgery(30 days after surgery)
  • Time to first defecation after surgery(at the time of the first defecation after surgery(expected average of 3 days after surgery))

研究者

发起方
Sixth Affiliated Hospital, Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

SanQing Jin

professor

Sixth Affiliated Hospital, Sun Yat-sen University

研究点 (1)

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