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

NCT04576533 | Recruiting

• 1 other identifier: 2020ZSLYEC-137
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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 colorectal surgery.

Conditions

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 (11)

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

  expected 7 days after surgery

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

  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 and at hospital discharge (up to 8 days after surgery

• Anxiety state evaluated by State-Trait Anxiety Inventory Form. The form used in this study is the Chinese version.

  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

• Severity of postoperative nausea and vomiting

  at 1-day, 2-day after surgery(up to 2 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 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

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 colectomy or laparoscopic rectectomy surgery (Dixon technique)
• \. American Society of anesthesiology (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;
• \. Patients with poor blood glucose control (glycosylated hemoglobin\>7%);
• \. 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 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 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 (15)

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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: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 6, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

CN (1)