Clinical trial NCT04029753: Patients Undergoing Laparoscopic Radical Gastrectomy Walk Out From Operating Room After Surgery ( WOFOR-G-01 )
Official title: Effects of Walking Out From Operating Room on Postoperative Recovery of Patients Undergoing Laparoscopic Radical Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Radical Gastrectomy
Enhanced Recovery After Surgery
Keywords: Early Mobilization
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-65 Years old
2. scheduled for laparoscopic radical gastrectomy.
3. American Society of Anesthesiologists (ASA) grading I or II

Exclusion Criteria:

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. Body mass index (BMI) ≥30 kg/m2;
3. Preoperative hemoglobin\<80 g/L or albumin\<30 g/L
4. Patients have diabetics or patients with gastric emptying disorders;
5. 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 );
6. Patients have schizophrenia, epilepsy, Parkinson's disease, mental retardation, or hearing impairment.
7. Patients have thrombosis such as in lower extremity or in vena cava or in other veins.
8. Patients have neuromuscular disorders affecting lower limb activity, such as myasthenia gravis and cerebral infarction, which cause lower limb muscle weakness;
9. Patients have contraindications for epidural puncture.
10. Postoperative placement of drainage tube for coelom hyperthermia perfusion
11. Patients participate in other clinical trials.
12. Patients refuse to sign informed consent for research.

Primary outcomes:
measure: Length of hospital stay after surgery
timeFrame: at hospital discharge(expected 7 days after surgery)
Secondary outcomes:
measure: Time to fulfill the criteria of hospital discharge
timeFrame: expected 7 days after surgery
measure: The percentage of patients feeling ready for hospital discharge when they reach the discharge criteria.
timeFrame: expected 6 days after surgery
measure: Postoperative recovery score using 40-item quality of recovery scoring system(QoR-40)
timeFrame: 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)...)
measure: Six-minute walking test
timeFrame: 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)...)
measure: Anxiety score
timeFrame: 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)...)
measure: Postoperative pain score
timeFrame: 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)...)
measure: Severity of postoperative nausea and vomiting
timeFrame: every 24 hours after surgery (at 1-day, 2-day, 3-day)
measure: Time to first flatus after surgery
timeFrame: from the time of operation completion until the time of the first flatus occurrence, assessed up to 7 days.
measure: Time to first defecation after surgery
timeFrame: from the time of operation completion until the time of the first defecation occurrence, assessed up to 10 days.
measure: The volume of drainage after surgery
timeFrame: every 24 hours from the time of operation completion until the time of drainage tube removal, assessed up to 30 days.
measure: Time to the removal of drainage tube
timeFrame: from the time of operation completion until the time of drainage tube removal, assessed up to 30 days.
measure: Incidence of surgical complications within 7 days after surgery
timeFrame: 7 days after surgery
measure: Incidence of surgical complications within 30 days after surgery
timeFrame: 30 days after surgery
measure: Unplanned re-admission incidence within 30 days after operation
timeFrame: 30 days after operation
measure: Incidence of major cardiovascular and cerebrovascular adverse events within 30 days after operation
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University
name: Sanqing Jin, MD
role: PRINCIPAL_INVESTIGATOR
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