Patients Undergoing Laparoscopic Radical Gastrectomy Walk Out From Operating Room After Surgery ( WOFOR-G-01 )

NCT04029753 | Unknown

• 1 other identifier: 2019ZSLYEC-053
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Radical Gastrectomy; 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 7 days after surgery)

Secondary Outcomes (15)

• Time to fulfill the criteria of hospital discharge

  expected 7 days after surgery

• The percentage of patients feeling ready for hospital discharge when they reach the discharge criteria.

  expected 6 days after surgery

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

  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)...)

• Six-minute walking test

  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)...)

• Anxiety score

  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)...)

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 radical gastrectomy, 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 radical gastrectomy.
• American Society of Anesthesiologists (ASA) grading I or 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;
• Preoperative hemoglobin\<80 g/L or albumin\<30 g/L
• 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 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.
• Postoperative placement of drainage tube for coelom hyperthermia perfusion
• 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 (1)

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Related Publications (11)

• Ding J, Sun B, Song P, Liu S, Chen H, Feng M, Guan W. The application of enhanced recovery after surgery (ERAS)/fast-track surgery in gastrectomy for gastric cancer: a systematic review and meta-analysis. Oncotarget. 2017 Jun 20;8(43):75699-75711. doi: 10.18632/oncotarget.18581. eCollection 2017 Sep 26.

  PMID: 29088903 BACKGROUND

• Mortensen K, Nilsson M, Slim K, Schafer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; Enhanced Recovery After Surgery (ERAS(R)) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Br J Surg. 2014 Sep;101(10):1209-29. doi: 10.1002/bjs.9582. Epub 2014 Jul 21.

  PMID: 25047143 BACKGROUND

• Pedziwiatr M, Mavrikis J, Witowski J, Adamos A, Major P, Nowakowski M, Budzynski A. Current status of enhanced recovery after surgery (ERAS) protocol in gastrointestinal surgery. Med Oncol. 2018 May 9;35(6):95. doi: 10.1007/s12032-018-1153-0.

  PMID: 29744679 BACKGROUND

• Mingjie X, Luyao Z, Ze T, YinQuan Z, Quan W. Laparoscopic Radical Gastrectomy for Resectable Advanced Gastric Cancer Within Enhanced Recovery Programs: A Prospective Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):959-964. doi: 10.1089/lap.2016.0057. Epub 2016 Nov 22.

  PMID: 27875094 BACKGROUND

• Chen Hu J, Xin Jiang L, Cai L, Tao Zheng H, Yuan Hu S, Bing Chen H, Chang Wu G, Fei Zhang Y, Chuan Lv Z. Preliminary experience of fast-track surgery combined with laparoscopy-assisted radical distal gastrectomy for gastric cancer. J Gastrointest Surg. 2012 Oct;16(10):1830-9. doi: 10.1007/s11605-012-1969-4. Epub 2012 Aug 2.

  PMID: 22854954 BACKGROUND

• Li MZ, Wu WH, Li L, Zhou XF, Zhu HL, Li JF, He YL. Is ERAS effective and safe in laparoscopic gastrectomy for gastric carcinoma? A meta-analysis. World J Surg Oncol. 2018 Jan 26;16(1):17. doi: 10.1186/s12957-018-1309-6.

  PMID: 29373978 BACKGROUND

• Ma Z, Bao X, Gu J. Effects of laparoscopic radical gastrectomy and the influence on immune function and inflammatory factors. Exp Ther Med. 2016 Aug;12(2):983-986. doi: 10.3892/etm.2016.3404. Epub 2016 May 27.

  PMID: 27446308 BACKGROUND

• Abdikarim I, Cao XY, Li SZ, Zhao YQ, Taupyk Y, Wang Q. Enhanced recovery after surgery with laparoscopic radical gastrectomy for stomach carcinomas. World J Gastroenterol. 2015 Dec 21;21(47):13339-44. doi: 10.3748/wjg.v21.i47.13339.

  PMID: 26715818 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

• Havey R, Herriman E, O'Brien D. Guarding the gut: early mobility after abdominal surgery. Crit Care Nurs Q. 2013 Jan-Mar;36(1):63-72. doi: 10.1097/CNQ.0b013e3182753237.

  PMID: 23221443 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

Zhinan Zheng, MD

CONTACT

0086-15915734893; 253039456@qq.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: July 14, 2019
• First Posted: July 23, 2019
• Study Start: August 27, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

CN (1)