Patients Undergoing Laparoscopic Nephrectomy Walk Out From Operating Room After Surgery

NCT03960697 | Unknown

• 1 other identifier: SixthSunYatSen
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 2

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.

Conditions

Laparoscopic Nephrectomy; Enhanced Recovery After Surgery

Keywords

early mobilization

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay after surgery

  hospital stay time from operation completion to actual hospital discharge,

  at hospital discharge(expected 6 days after surgery)

Secondary Outcomes (14)

• Time to fufill the criteria of hospital discharge (recovery time)

  expected 6 days after surgery

• 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

  30 days after operation

• Postoperative recovery score using 40-item quality of recovery scoring system(QoR-40)

  at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 days after surgery)

• Six-minute walking test

  the day before surgery, and at 1-day, 2-day, 3-day, 4-day after surgery(up to 4 days after surgery

Study Arms (2)

walk out from operating room

EXPERIMENTAL

patients will return to the ward after surgery by walking

Behavioral: walk out from operating room

leave operating room by transporting bed

NO INTERVENTION

patients will return to the ward after surgery by lying on the transporting bed

Interventions

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

walk out from operating room

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 Years old
• scheduled for laparoscopic partial nephrectomy or laparoscopic total nephrectomy.
• ASA grade I or grade II

You may not qualify if:

• 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
• 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 renal vein 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.
• Patients participate in other clinical trials.
• Patients refuse to sign informed consent for research.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (2)

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

The sixth affiliated hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Related Publications (15)

• 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.

  PMID: 18784846 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.

  PMID: 23968966 BACKGROUND

• 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.

  PMID: 25892343 BACKGROUND

• 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, Pokupic 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.

  PMID: 27234997 BACKGROUND

• Patel HR, Cerantola Y, Valerio M, Persson B, Jichlinski P, Ljungqvist O, Hubner M, Kassouf W, Muller 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.

  PMID: 24183418 BACKGROUND

• 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.

  PMID: 29454972 BACKGROUND

• 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.

  PMID: 26970912 BACKGROUND

• 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.

  PMID: 27297680 BACKGROUND

• 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((R))) society recommendations. Clin Nutr. 2013 Dec;32(6):879-87. doi: 10.1016/j.clnu.2013.09.014. Epub 2013 Oct 17.

  PMID: 24189391 BACKGROUND

• 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.

  PMID: 29032237 BACKGROUND

• 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.

  PMID: 28222423 BACKGROUND

• 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.

  PMID: 21160309 BACKGROUND

• 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.

  PMID: 26059985 BACKGROUND

• 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.

  PMID: 29753000 BACKGROUND

• 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.

  PMID: 28348739 BACKGROUND

Study Officials

• SanQing Jin, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SanQing Jin, MD

CONTACT

0086-13719366863; sanqingjin@hotmail.com

Yang Zhao, MD

CONTACT

0086-13802435520; md03yang@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 23, 2019
• Study Start: June 4, 2019
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

CN (2)