4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Patients Undergoing Laparoscopic Nephrectomy Walk Out From Operating Room After Surgery (WOFOR-N1)

Patients Undergoing Laparoscopic Nephrectomy Walk Out From Operating Room After Surgery (WOFOR-N1)

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Laparoscopic Nephrectomy Enhanced Recovery After Surgery Behavioral: walk out from operating room Not Applicable

Detailed Description:

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Walking Out From Operating Room on Postoperative Recovery of Patients Undergoing Laparoscopic Total or Partial Nephrectomy
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: walk out from operating room
patients will return to the ward after surgery by walking
 Behavioral: walk out from operating room
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
No Intervention: leave operating room by transporting bed
patients will return to the ward after surgery by lying on the transporting bed
Outcome Measures
Primary Outcome Measures :
  1. Length of hospital stay after surgery [ Time Frame: at hospital discharge(expected 6 days after surgery) ]
    hospital stay time from operation completion to actual hospital discharge,


Secondary Outcome Measures :
  1. Time to fufill the criteria of hospital discharge (recovery time) [ Time Frame: expected 6 days after surgery ]
    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

  2. The percentage of patients feeling ready for hospital discharge when they reach the discharge criteria. [ Time Frame: expected 6 days after surgery ]
    The percentage of patients feeling ready for hospital discharge when they reach the discharge criteria.

  3. Re-admission incidence within 30 days after operation [ Time Frame: 30 days after operation ]
    Incidence of admit to hospital again within 30 days after operation

  4. Postoperative recovery score using 40-item quality of recovery scoring system(QoR-40) [ Time Frame: at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 days after surgery) ]
    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).

  5. Six-minute walking test [ Time Frame: the day before surgery, and at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 days after surgery ]
    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.

  6. Anxiety score [ Time Frame: the day before surgery, and at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 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 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.

  7. Postoperative pain score [ Time Frame: at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 days after surgery) ]
    Pain score after surgery is evaluated using a visual analogue scale 0-10 rated by the patients

  8. Severity of postoperative nausea and vomiting [ Time Frame: at 1-day, 2-day after surgery(up to 2 days after surgery) ]
    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.

  9. Time to first flatus after surgery [ Time Frame: at the time of first exhaust after surgery(expected average of 2 days after surgery) ]
    the time length between operation completion and the first flatus

  10. Time to first defecation after surgery [ Time Frame: at the time of the first defecation after surgery(expected average of 3 days after surgery) ]
    the time length between operation completion and the first defecation

  11. The volume of drainage after surgery [ Time Frame: expected average of 4 days after surgery ]
    Total volume of drainage after surgery and drainage volume at 24-hour and 48-hour after the end of surgery.

  12. Time to the removal of drainage tube [ Time Frame: at the time of drainage removal(expected average of 4 days after surgery) ]
    recorded the time length between operation completion and the removal of drainage tube

  13. Incidence of surgical complications within 30 days after surgery [ Time Frame: 30 days after surgery ]
    Incidence of bleeding, wound infection, wound dehiscence within 30 days after surgery

  14. Incidence of major cardiovascular and cerebrovascular adverse events within 30 days after operation [ Time Frame: 30 days after surgery ]
    Incidence of a complex event consisting of all-cause death, myocardial infarction, stroke and emergency target vessel revascularization within 30 days after surgery


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-65 Years old
  2. scheduled for laparoscopic partial nephrectomy or laparoscopic total nephrectomy.
  3. ASA grade I or grade 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. Patients have diabetics or patients with gastric emptying disorders;
  4. 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 );
  5. Patients have schizophrenia, epilepsy, Parkinson's disease, mental retardation, or hearing impairment.
  6. Patients have thrombosis such as in lower extremity or in vena cava or in renal vein or in other veins.
  7. Patients have neuromuscular disorders affecting lower limb activity, such as myasthenia gravis and cerebral infarction, which cause lower limb muscle weakness;
  8. Patients have contraindications for epidural puncture.
  9. Patients participate in other clinical trials.
  10. Patients refuse to sign informed consent for research.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: SanQing Jin, MD 0086-13719366863 sanqingjin@hotmail.com
Contact: Yang Zhao, MD 0086-13802435520 md03yang@126.com

Locations
Layout table for location information
China, Guangdong
the Sixth Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: SanQing Jin, MD    0086-13719366863    sanqingjin@hotmail.com   
Sub-Investigator: Yang Zhao, MD         
The sixth affiliated hospital,Sun Yat-sen University Recruiting
GuangZhou, Guangdong, China, 510655
Contact: SanQing Jin    0086-13719366863    sanqingjin@hotmail.com   
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: SanQing Jin, MD the Sixth Affiliated Hospital, Sun Yat-sen University
Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date January 6, 2020
Actual Study Start Date  ICMJE June 4, 2019
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019) 		Length of hospital stay after surgery [ Time Frame: at hospital discharge(expected 6 days after surgery) ]
hospital stay time from operation completion to actual hospital discharge,
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Time to fufill the criteria of hospital discharge (recovery time) [ Time Frame: expected 6 days after surgery ]
    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
  • The percentage of patients feeling ready for hospital discharge when they reach the discharge criteria. [ Time Frame: expected 6 days after surgery ]
    The percentage of patients feeling ready for hospital discharge when they reach the discharge criteria.
  • Re-admission incidence within 30 days after operation [ Time Frame: 30 days after operation ]
    Incidence of admit to hospital again within 30 days after operation
  • Postoperative recovery score using 40-item quality of recovery scoring system(QoR-40) [ Time Frame: at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 days after surgery) ]
    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).
  • Six-minute walking test [ Time Frame: the day before surgery, and at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 days after surgery ]
    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.
  • Anxiety score [ Time Frame: the day before surgery, and at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 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 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.
  • Postoperative pain score [ Time Frame: at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 days after surgery) ]
    Pain score after surgery is evaluated using a visual analogue scale 0-10 rated by the patients
  • Severity of postoperative nausea and vomiting [ Time Frame: at 1-day, 2-day after surgery(up to 2 days after surgery) ]
    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.
  • Time to first flatus after surgery [ Time Frame: at the time of first exhaust after surgery(expected average of 2 days after surgery) ]
    the time length between operation completion and the first flatus
  • Time to first defecation after surgery [ Time Frame: at the time of the first defecation after surgery(expected average of 3 days after surgery) ]
    the time length between operation completion and the first defecation
  • The volume of drainage after surgery [ Time Frame: expected average of 4 days after surgery ]
    Total volume of drainage after surgery and drainage volume at 24-hour and 48-hour after the end of surgery.
  • Time to the removal of drainage tube [ Time Frame: at the time of drainage removal(expected average of 4 days after surgery) ]
    recorded the time length between operation completion and the removal of drainage tube
  • Incidence of surgical complications within 30 days after surgery [ Time Frame: 30 days after surgery ]
    Incidence of bleeding, wound infection, wound dehiscence within 30 days after surgery
  • Incidence of major cardiovascular and cerebrovascular adverse events within 30 days after operation [ Time Frame: 30 days after surgery ]
    Incidence of a complex event consisting of all-cause death, myocardial infarction, stroke and emergency target vessel revascularization within 30 days after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patients Undergoing Laparoscopic Nephrectomy Walk Out From Operating Room After Surgery
Official Title  ICMJE Effects of Walking Out From Operating Room on Postoperative Recovery of Patients Undergoing Laparoscopic Total or Partial Nephrectomy
Brief Summary 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.
Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Laparoscopic Nephrectomy
  • Enhanced Recovery After Surgery
Intervention  ICMJE Behavioral: walk out from operating room
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
Study Arms  ICMJE
  • Experimental: walk out from operating room
    patients will return to the ward after surgery by walking
    Intervention: Behavioral: walk out from operating room
  • No Intervention: leave operating room by transporting bed
    patients will return to the ward after surgery by lying on the transporting bed
Publications *
  • 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. 2008:507543. doi: 10.1155/2008/507543.
  • 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.
  • Barreca M, Renzi C, Tankel J, Shalhoub J, Sengupta N. Is there a role for enhanced recovery after laparoscopic bariatric surgery? Preliminary results from a specialist obesity treatment center. Surg Obes Relat Dis. 2016 Jan;12(1):119-26. doi: 10.1016/j.soard.2015.03.008. Epub 2015 Mar 20.
  • Collins JW, Patel H, Adding C, Annerstedt M, Dasgupta P, Khan SM, Artibani W, Gaston R, Piechaud T, Catto JW, Koupparis A, Rowe E, Perry M, Issa R, McGrath J, Kelly J, Schumacher M, Wijburg C, Canda AE, Balbay MD, Decaestecker K, Schwentner C, Stenzl A, Edeling S, Pokupić S, Stockle M, Siemer S, Sanchez-Salas R, Cathelineau X, Weston R, Johnson M, D'Hondt F, Mottrie A, Hosseini A, Wiklund PN. Enhanced Recovery After Robot-assisted Radical Cystectomy: EAU Robotic Urology Section Scientific Working Group Consensus View. Eur Urol. 2016 Oct;70(4):649-660. doi: 10.1016/j.eururo.2016.05.020. Epub 2016 May 24. Review.
  • Patel HR, Cerantola Y, Valerio M, Persson B, Jichlinski P, Ljungqvist O, Hubner M, Kassouf W, Müller S, Baldini G, Carli F, Naesheim T, Ytrebo L, Revhaug A, Lassen K, Knutsen T, Aarsaether E, Wiklund P, Catto JW. Enhanced recovery after surgery: are we ready, and can we afford not to implement these pathways for patients undergoing radical cystectomy? Eur Urol. 2014 Feb;65(2):263-6. doi: 10.1016/j.eururo.2013.10.011. Epub 2013 Oct 22.
  • Palumbo V, Giannarini G, Crestani A, Rossanese M, Calandriello M, Ficarra V. Enhanced Recovery After Surgery Pathway in Patients Undergoing Open Radical Cystectomy Is Safe and Accelerates Bowel Function Recovery. Urology. 2018 May;115:125-132. doi: 10.1016/j.urology.2018.01.043. Epub 2018 Feb 15.
  • Azhar RA, Bochner B, Catto J, Goh AC, Kelly J, Patel HD, Pruthi RS, Thalmann GN, Desai M. Enhanced Recovery after Urological Surgery: A Contemporary Systematic Review of Outcomes, Key Elements, and Research Needs. Eur Urol. 2016 Jul;70(1):176-187. doi: 10.1016/j.eururo.2016.02.051. Epub 2016 Mar 9. Review.
  • Tyson MD, Chang SS. Enhanced Recovery Pathways Versus Standard Care After Cystectomy: A Meta-analysis of the Effect on Perioperative Outcomes. Eur Urol. 2016 Dec;70(6):995-1003. doi: 10.1016/j.eururo.2016.05.031. Epub 2016 Jun 11. Review.
  • Cerantola Y, Valerio M, Persson B, Jichlinski P, Ljungqvist O, Hubner M, Kassouf W, Muller S, Baldini G, Carli F, Naesheimh T, Ytrebo L, Revhaug A, Lassen K, Knutsen T, Aarsether E, Wiklund P, Patel HR. Guidelines for perioperative care after radical cystectomy for bladder cancer: Enhanced Recovery After Surgery (ERAS(®)) society recommendations. Clin Nutr. 2013 Dec;32(6):879-87. doi: 10.1016/j.clnu.2013.09.014. Epub 2013 Oct 17. Review.
  • Semerjian A, Milbar N, Kates M, Gorin MA, Patel HD, Chalfin HJ, Frank SM, Wu CL, Yang WW, Hobson D, Robertson L, Wick E, Schoenberg MP, Pierorazio PM, Johnson MH, Stimson CJ, Bivalacqua TJ. Hospital Charges and Length of Stay Following Radical Cystectomy in the Enhanced Recovery After Surgery Era. Urology. 2018 Jan;111:86-91. doi: 10.1016/j.urology.2017.09.010. Epub 2017 Oct 13.
  • Sugi M, Matsuda T, Yoshida T, Taniguchi H, Mishima T, Yanishi M, Komai Y, Yasuda K, Kinoshita H, Yoshida K, Watanabe M. Introduction of an Enhanced Recovery after Surgery Protocol for Robot-Assisted Laparoscopic Radical Prostatectomy. Urol Int. 2017;99(2):194-200. doi: 10.1159/000457805. Epub 2017 Feb 17.
  • Lee TG, Kang SB, Kim DW, Hong S, Heo SC, Park KJ. Comparison of early mobilization and diet rehabilitation program with conventional care after laparoscopic colon surgery: a prospective randomized controlled trial. Dis Colon Rectum. 2011 Jan;54(1):21-8. doi: 10.1007/DCR.0b013e3181fcdb3e.
  • van der Leeden M, Huijsmans R, Geleijn E, de Lange-de Klerk ES, Dekker J, Bonjer HJ, van der Peet DL. Early enforced mobilisation following surgery for gastrointestinal cancer: feasibility and outcomes. Physiotherapy. 2016 Mar;102(1):103-10. doi: 10.1016/j.physio.2015.03.3722. Epub 2015 May 7.
  • Ni CY, Wang ZH, Huang ZP, Zhou H, Fu LJ, Cai H, Huang XX, Yang Y, Li HF, Zhou WP. Early enforced mobilization after liver resection: A prospective randomized controlled trial. Int J Surg. 2018 Jun;54(Pt A):254-258. doi: 10.1016/j.ijsu.2018.04.060. Epub 2018 May 9.
  • da Costa Torres D, Dos Santos PM, Reis HJ, Paisani DM, Chiavegato LD. Effectiveness of an early mobilization program on functional capacity after coronary artery bypass surgery: A randomized controlled trial protocol. SAGE Open Med. 2016 Dec 14;4:2050312116682256. doi: 10.1177/2050312116682256. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019) 		182
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-65 Years old
  2. scheduled for laparoscopic partial nephrectomy or laparoscopic total nephrectomy.
  3. ASA grade I or grade 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. Patients have diabetics or patients with gastric emptying disorders;
  4. 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 );
  5. Patients have schizophrenia, epilepsy, Parkinson's disease, mental retardation, or hearing impairment.
  6. Patients have thrombosis such as in lower extremity or in vena cava or in renal vein or in other veins.
  7. Patients have neuromuscular disorders affecting lower limb activity, such as myasthenia gravis and cerebral infarction, which cause lower limb muscle weakness;
  8. Patients have contraindications for epidural puncture.
  9. Patients participate in other clinical trials.
  10. Patients refuse to sign informed consent for research.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: SanQing Jin, MD 0086-13719366863 sanqingjin@hotmail.com
Contact: Yang Zhao, MD 0086-13802435520 md03yang@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960697
Other Study ID Numbers  ICMJE SixthSunYatSen
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SanQing Jin, Sixth Affiliated Hospital, Sun Yat-sen University
Study Sponsor  ICMJE Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: SanQing Jin, MD the Sixth Affiliated Hospital, Sun Yat-sen University
PRS Account Sixth Affiliated Hospital, Sun Yat-sen University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

治疗案例

前沿医讯