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

Enhanced Recovery After Surgery Clinical Trial

Official title:

Effects of Walking Out From Operating Room on Postoperative Recovery of Patients Undergoing Laparoscopic Radical Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04029753
• Other study ID #: 2019ZSLYEC-053
• Status: Recruiting
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2022
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Sanqing Jin, MD
• Phone: 0086-13719366863
• Email: sanqingjin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Postoperative bed rest increases the risk of complications such as thromboembolism and intestinal adhesion, but actual clinical 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 the operating room (very early mobilization after surgery) on the postoperative recovery of patients undergoing laparoscopic radical gastrectomy.

A sample size of 96 patients in each group is calculated 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 deviations are 2 days in the experimental group and the control group, (3)α=0.05, (4) power 90% and (5) missed follow-up rate 10%. Considering that this study is not for rare diseases, in order to ensure adequate sample size, we adjust the sample size of each group to an integer of 100.

Patients will receive written and verbal information about the trial before written consent is obtained. The randomization will take place when the surgeons confirm preliminarily there is no need to place drainage tube for coelom hyperthermia perfusion after laparoscopy. Then 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, age and total or distal gastrectomy 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18-65 Years old

2. scheduled for laparoscopic radical gastrectomy.

3. American Society of Anesthesiologists (ASA) grading I or 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. Preoperative hemoglobin<80 g/L or albumin<30 g/L

4. Patients have diabetics or patients with gastric emptying disorders;

5. 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 );

6. Patients have schizophrenia, epilepsy, Parkinson's disease, mental retardation, or hearing impairment.

7. Patients have thrombosis such as in lower extremity or in vena cava or in other veins.

8. Patients have neuromuscular disorders affecting lower limb activity, such as myasthenia gravis and cerebral infarction, which cause lower limb muscle weakness;

9. Patients have contraindications for epidural puncture.

10. Postoperative placement of drainage tube for coelom hyperthermia perfusion

11. Patients participate in other clinical trials.

12. Patients refuse to sign informed consent for research.

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Laparoscopic Radical Gastrectomy

Intervention

Behavioral:
• Walk out from operating room
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.

Locations

Country	Name	City	State
China	the Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (11)

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. — View Citation

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. Epub 2012 Aug 2. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2016 May 27. — View Citation

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. — View Citation

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

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. Review. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to fulfill the criteria of hospital discharge	the ideal time point for discharge, which is also considered as recovery time. The criteria for measuring recovery time included: 1) the patients receive 80% of normal nutritional support (30 kcal/kg/day calories is regard as normal nutritional support)and 30ml/kg fluid intake by oral; 2)gastrointestinal function has been restored: flatus with or without defecation; 3)analgesic-free, which is defined as visual analogue scale =3 without intravenous analgesic drugs, 4) adequate mobility without support; 5) afebrile status without major infectious complications	expected 7 days after surgery
Secondary	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
Secondary	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). 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).	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)...)
Secondary	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, 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)...)
Secondary	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, 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)...)
Secondary	Postoperative pain score	pain score after surgery is evaluated using a visual analogue scale 0-10 rated by the patients	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)...)
Secondary	Severity of postoperative nausea and vomiting	everity of postoperative nausea and vomiting is measured with the PONV intensity grading. 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.	every 24 hours after surgery (at 1-day, 2-day, 3-day)
Secondary	Time to first flatus after surgery	the time length between operation completion and the first flatus	from the time of operation completion until the time of the first flatus occurrence, assessed up to 7 days.
Secondary	Time to first defecation after surgery	the time length between operation completion and the first defecation	from the time of operation completion until the time of the first defecation occurrence, assessed up to 10 days.
Secondary	The volume of drainage after surgery	total volume of drainage after surgery and drainage volume every 24 hours after surgery.	every 24 hours from the time of operation completion until the time of drainage tube removal, assessed up to 30 days.
Secondary	Time to the removal of drainage tube	recorded the time length between operation completion and the removal of drainage tube	from the time of operation completion until the time of drainage tube removal, assessed up to 30 days.
Secondary	Incidence of surgical complications within 7 days after surgery	incidence of bleeding, wound infection, wound dehiscence, ileus, stenosis, Leakage within 30 days after surgery	7 days after surgery
Secondary	Incidence of surgical complications within 30 days after surgery	incidence of bleeding, wound infection, wound dehiscence, ileus, stenosis, Leakage within 30 days after surgery	30 days after surgery
Secondary	Unplanned re-admission incidence within 30 days after operation	incidence of unplanned admit to hospital again within 30 days after operation	30 days after operation
Secondary	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 operation