Patients Undergoing Laparoscopic Colorectal Surgery Walk Out From Operating Room After Surgery ( WOFOR-C1 )

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

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 colorectal surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age 18-65 Years old

2. scheduled for laparoscopic colectomy or laparoscopic rectectomy surgery (Dixon technique)

3. American Society of anesthesiology (ASA) grade I or grade II

Disqualifiers

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. Patients with poor blood glucose control (glycosylated hemoglobin>7%);

3. 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 );

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • walk out from operating room

    Behavioral

    After the surgery of laparoscopic colectomy or laparoscopic rectectomy surgery (Dixon technique), 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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: walk out from operating roomExperimental treatment 1 intervention
Group B: leave operating room by transporting bedNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Length of hospital stay after surgery

hospital stay time from operation completion to actual hospital discharge

Time frame
at hospital discharge(expected 7 days after surgery)

Secondary outcomes

1

Time to fulfill the criteria of hospital discharge (recovery time)

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

Time frame
expected 7 days after surgery
2

Re-admission incidence within 30 days after operation because of surgical complication

Incidence of admit to hospital again within 30 days after operation because of surgical complication

Time frame
30 days after operation
3

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)

Time frame
at 1-day, 2-day, 3-day, 4-day after surgery and at hospital discharge (up to 8 days after surgery
4

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 State-Trait Anxiety Index 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

Time frame
the day before surgery, and at 1-day, 2-day, 3-day, 4-day after surgery and at hospital discharge(up to 8 days after surgery

Other outcomes

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