An interventional study of walk out from operating room in Enhanced Recovery After Surgery, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Not applicable, Interventional, and Supportive care
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.
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.
Summary statistics of mean (SD) for normally distributed data or median (IQR) for skewed data will be generated for continuous variables, and frequency (percentage) will be generated for categorical or ordinal variables. Continuous variables will be analyzed by Student's t test or Mann-Whitney U test or Repeated Measures Analysis of Variance, and categorical outcomes will be analyzed by χ² test.
Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 217 studies on the registry; 111 are open to participants now.
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Exclusion Criteria:
patients will return to the ward after surgery by walking
Behavioral: walk out from operating room
patients will return to the ward after surgery by lying on the transporting bed
After the surgery of laparoscopic colectomy or laparoscopic rectectomy surgery (Dixon technique), 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
Length of hospital stay after surgery
hospital stay time from operation completion to actual hospital discharge
Time frame: at hospital discharge(expected 7 days after surgery)
Time to fulfill the criteria of hospital discharge (recovery time)
The ideal time point for discharge, which is also considered as recovery time. The criteria for measuring recovery time included: 1) tolerance of diet and not necessary for intravenous nutrition; 2) analgesic-free, which is defined as visual analogue scale ≤3 without intravenous analgesic drugs, 3) adequate mobility; 4) afebrile status without major infectious complications
Time frame: expected 7 days after surgery
Re-admission incidence within 30 days after operation because of surgical complication
Incidence of admit to hospital again within 30 days after operation because of surgical complication
Time frame: 30 days after operation
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)
Time frame: at 1-day, 2-day, 3-day, 4-day after surgery and at hospital discharge (up to 8 days after surgery
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 State-Trait Anxiety Index 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
Time frame: 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
Severity of postoperative nausea and vomiting
Severity of postoperative nausea and vomiting is measured with the postoperative nausea and vomiting(PONV) intensity scale. 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.
Time frame: at 1-day, 2-day after surgery(up to 2 days after surgery)
Time to first flatus after surgery
the time length between operation completion and the first flatus
Time frame: at the time of first exhaust after surgery(expected average of 2 days after surgery)
Time to first defecation after surgery
the time length between operation completion and the first defecation
Time frame: at the time of the first defecation after surgery(expected average of 3 days after surgery)
The volume of drainage after surgery
Total volume of drainage after surgery and drainage volume at 24-hour and 48-hour after the end of surgery
Time frame: expected average of 4 days after surgery
Time to the removal of drainage tube
recorded the time length between operation completion and the removal of drainage tube
Time frame: at the time of drainage removal(expected average of 4 days after surgery)
Incidence of surgical complications within 30 days after surgery
Incidence of bleeding, wound infection, wound dehiscence within 30 days after surgery
Time frame: 30 days after surgery
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
Time frame: 30 days after surgery
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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