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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 total and partial nephrectomy.
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 total and partial nephrectomy.
A sample size of 91 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, (2) standard deviation 2 days, (3) α=0.05, (4) power 90% 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, disease character and age 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| walk out from operating room | Experimental | patients will return to the ward after surgery by walking |
|
| leave operating room by transporting bed | No Intervention | patients will return to the ward after surgery by lying on the transporting bed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| walk out from operating room | Behavioral | After the surgery of laparoscopic total or partial nephrectomy, 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay after surgery | hospital stay time from operation completion to actual hospital discharge, | at hospital discharge(expected 6 days after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to fufill 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SanQing Jin, MD | Contact | 0086-13719366863 | sanqingjin@hotmail.com | |
| Yang Zhao, MD | Contact | 0086-13802435520 | md03yang@126.com |
| Name | Affiliation | Role |
|---|---|---|
| SanQing Jin, MD | The Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18784846 | Background | Chughtai B, Abraham C, Finn D, Rosenberg S, Yarlagadda B, Perrotti M. Fast track open partial nephrectomy: reduced postoperative length of stay with a goal-directed pathway does not compromise outcome. Adv Urol. 2008;2008:507543. doi: 10.1155/2008/507543. | |
| 23968966 | Background | Karl A, Buchner A, Becker A, Staehler M, Seitz M, Khoder W, Schneevoigt B, Weninger E, Rittler P, Grimm T, Gratzke C, Stief C. A new concept for early recovery after surgery for patients undergoing radical cystectomy for bladder cancer: results of a prospective randomized study. J Urol. 2014 Feb;191(2):335-40. doi: 10.1016/j.juro.2013.08.019. Epub 2013 Aug 19. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2019 | May 20, 2019 | Prot_SAP_000.pdf |
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|
| expected 6 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 |
| Re-admission incidence within 30 days after operation | Incidence of admit to hospital again within 30 days after operation | 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 (9 items), 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). | at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 days after surgery) |
| 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, and at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 days after surgery |
| 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, and at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 days after surgery |
| Postoperative pain score | Pain score after surgery is evaluated using a visual analogue scale 0-10 rated by the patients | at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 days after surgery) |
| Severity of postoperative nausea and vomiting | Severity of postoperative nausea and vomiting is measured with the 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. | 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 | 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 | 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. | 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 | 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 | 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 | 30 days after surgery |
| The sixth affiliated hospital,Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
|
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