Patients Undergoing Laparoscopic Radical Gastrectomy Walk Out From Operating Room After Surgery ( WOFOR-G-01 )

Study Overview
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Brief Summary
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Although early and progressive mobility is widely accepted as an important aspect of postoperative care, guidelines and recommendations suggesting the exact timing and intensity of mobilization efforts are nonexistent. We propose the concept of walking out from the operating room (WOFOR), which means under meticulous anesthesia treatment, perfect postoperative analgesia conditions, rigorous assessment of consciousness and normal muscle strength, postoperative patients can walk safely out of the operating room and return to the ward. The aim of this randomized controlled trial is to investigate the effect of walking out from the operating room on the postoperative recovery of patients undergoing laparoscopic radical gastrectomy.

Detailed Description
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Postoperative bed rest increases the risk of complications such as thromboembolism and intestinal adhesion, but actual clinical 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 the operating room (very early mobilization after surgery) on the postoperative recovery of patients undergoing laparoscopic radical gastrectomy. A sample size of 96 patients in each group is calculated 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, (2) standard deviations are 2 days in the experimental group and the control group, (3)α=0.05, (4) power 90% and (5) missed follow-up rate 10%. Considering that this study is not for rare diseases, in order to ensure adequate sample size, we adjust the sample size of each group to an integer of 100. Patients will receive written and verbal information about the trial before written consent is obtained. The randomization will take place when the surgeons confirm preliminarily there is no need to place drainage tube for coelom hyperthermia perfusion after laparoscopy. Then 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, age and total or distal gastrectomy 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, 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.

Official Title
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Effects of Walking Out From Operating Room on Postoperative Recovery of Patients Undergoing Laparoscopic Radical Gastrectomy

Conditions
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Laparoscopic Radical Gastrectomy, Enhanced Recovery After Surgery

Intervention / Treatment
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* Behavioral: Walk out from operating room


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 Years old scheduled for laparoscopic radical gastrectomy. American Society of Anesthesiologists (ASA) grading I or II Exclusion Criteria: 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; Body mass index (BMI) ≥30 kg/m2; Preoperative hemoglobin<80 g/L or albumin<30 g/L Patients have diabetics or patients with gastric emptying disorders; 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 ); Patients have schizophrenia, epilepsy, Parkinson's disease, mental retardation, or hearing impairment. Patients have thrombosis such as in lower extremity or in vena cava or in other veins. Patients have neuromuscular disorders affecting lower limb activity, such as myasthenia gravis and cerebral infarction, which cause lower limb muscle weakness; Patients have contraindications for epidural puncture. Postoperative placement of drainage tube for coelom hyperthermia perfusion Patients participate in other clinical trials. Patients refuse to sign informed consent for research.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walk out from operating room<br>Patients will return to the ward after surgery by walking. | Behavioral: Walk out from operating room<br>* After the surgery of laparoscopic radical gastrectomy, patients will be encouraged to walk out from the operating room and return to the ward by walking under the condition of stable physiological parameters, painlessness, clear consciousness and normal muscle strength of lower limb.<br>|
| No Intervention: Leave operating room by transporting bed<br>Patients will return to the ward after surgery by lying on the transporting bed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay after surgery | hospital stay time from operation completion to actual hospital discharge | at hospital discharge(expected 7 days after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to fulfill the criteria of hospital discharge | the ideal time point for discharge, which is also considered as recovery time. The criteria for measuring recovery time included: 1) the patients receive 80% of normal nutritional support （30 kcal/kg/day calories is regard as normal nutritional support）and 30ml/kg fluid intake by oral; 2)gastrointestinal function has been restored: flatus with or without defecation; 3)analgesic-free, which is defined as visual analogue scale ≤3 without intravenous analgesic drugs, 4) adequate mobility without support; 5) afebrile status without major infectious complications | expected 7 days after surgery | 
| The percentage of patients feeling ready for hospital discharge when they reach the discharge criteria. | the percentage of patients feeling ready for hospital discharge when they reach the discharge criteria. | expected 6 days after surgery | 
| Postoperative recovery score using 40-item quality of recovery scoring system(QoR-40) | to evaluate the postoperative recovery using 40-item quality of recovery scoring system including emotional state (9items), physical comfort (12 items), physical independence (5 items), psychologic support (7 items), and pain (7 items). Each item is graded on a five-point Likert scale, and global scores range from 40 (extremely poor quality of recovery)to 200 (high quality of recovery). Each item is graded on a five-point Likert scale, and global scores range from 40 (extremely poor quality of recovery) to 200 (high quality of recovery). | every 24 hours after surgery (at 1-day, 2-day, 3-day), and then every 48 hours until the discharge after surgery (at 5-day, 7-day (if any), 9-day (if any)...) | 
| Six-minute walking test | physical capacity measured with the six-minute Walking test before surgery and after surgery.The longer walking distance in six minutes, the better physical capacity. | the day before surgery, every 24 hours after surgery (at 1-day, 2-day, 3-day), and then every 48 hours until the discharge after surgery (at 5-day, 7-day (if any), 9-day (if any)...) | 
| Anxiety score | anxiety state evaluated by State-Trait Anxiety Inventory Form. The form used in this study is the Chinese version. The scales consist of 20 items; the responses range from 1 to 4 points (forced choice). The scores range from 20 (extremely low level of anxiety) to 80 (high level of anxiety). The STAI classifies anxiety into five stages: stages 1 and 2 suggest mild anxiety; stage 3 suggests moderate anxiety, and stages 4 and 5 suggest severe anxiety. | the day before surgery, every 24 hours after surgery (at 1-day, 2-day, 3-day), and then every 48 hours until the discharge after surgery (at 5-day, 7-day (if any), 9-day (if any)...) | 
| Postoperative pain score | pain score after surgery is evaluated using a visual analogue scale 0-10 rated by the patients | every 24 hours after surgery (at 1-day, 2-day, 3-day), and then every 48 hours until the discharge after surgery (at 5-day, 7-day (if any), 9-day (if any)...) | 
| Severity of postoperative nausea and vomiting | everity of postoperative nausea and vomiting is measured with the PONV intensity grading. Briefly, no PONV is defined as the absence of any emetic symptoms and nausea during the entire study period. Mild PONV is defined as the occurrence of mild nausea or one episode of vomiting if caused by an exogenous stimulus such as drinking or movement. Moderate PONV is reached when the patient vomits up to 2 times or experiences nausea that requires a rescue antiemetic therapy only once. Severe PONV is reached if the patient suffers more than two emetic episodes or needs more than one dose of a rescue antiemetic drugs. | every 24 hours after surgery (at 1-day, 2-day, 3-day) | 
| Time to first flatus after surgery | the time length between operation completion and the first flatus | from the time of operation completion until the time of the first flatus occurrence, assessed up to 7 days. | 
| Time to first defecation after surgery | the time length between operation completion and the first defecation | from the time of operation completion until the time of the first defecation occurrence, assessed up to 10 days. | 
| The volume of drainage after surgery | total volume of drainage after surgery and drainage volume every 24 hours after surgery. | every 24 hours from the time of operation completion until the time of drainage tube removal, assessed up to 30 days. | 
| Time to the removal of drainage tube | recorded the time length between operation completion and the removal of drainage tube | from the time of operation completion until the time of drainage tube removal, assessed up to 30 days. | 
| Incidence of surgical complications within 7 days after surgery | incidence of bleeding, wound infection, wound dehiscence, ileus, stenosis, Leakage within 30 days after surgery | 7 days after surgery | 
| Incidence of surgical complications within 30 days after surgery | incidence of bleeding, wound infection, wound dehiscence, ileus, stenosis, Leakage within 30 days after surgery | 30 days after surgery | 
| Unplanned re-admission incidence within 30 days after operation | incidence of unplanned admit to hospital again within 30 days after operation | 30 days after operation | 
| Incidence of major cardiovascular and cerebrovascular adverse events within 30 days after operation | incidence of a complex event consisting of all-cause death, myocardial infarction, stroke and emergency target vessel revascularization within 30 days after surgery | 30 days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Mobilization