Patients Undergoing Laparoscopic Nephrectomy Walk Out From Operating Room After Surgery

NCT ID: NCT03960697

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-04
• Study Completion Date: 2023-08-31

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.

Conditions

Laparoscopic Nephrectomy; Enhanced Recovery After Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

walk out from operating room

patients will return to the ward after surgery by walking

Group Type: EXPERIMENTAL

walk out from operating room

Intervention Type: 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

leave operating room by transporting bed

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

SanQing Jin

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SanQing Jin, MD

Role: PRINCIPAL_INVESTIGATOR

The Sixth Affiliated Hospital, Sun Yat-sen University

Locations

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

The sixth affiliated hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

SanQing Jin, MD

Role: CONTACT

sanqingjin@hotmail.com

0086-13719366863

Yang Zhao, MD

Role: CONTACT

md03yang@126.com

0086-13802435520

Facility Contacts

SanQing Jin, MD

Role: primary

sanqingjin@hotmail.com

0086-13719366863

SanQing Jin

Role: primary

sanqingjin@hotmail.com

0086-13719366863

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SixthSunYatSen

Identifier Type: -

Identifier Source: org_study_id